CD 006194

External xation versus conservative treatment for distal radial fractures in adults (Review)
Handoll HHG, Huntley JS, Madhok R
This is a reprint of a Cochrane review, prepared and maintained by The Cochrane Collaboration and published in The Cochrane Library 2008, Issue 4 http://www.thecochranelibrary.com
External xation versus conservative treatment for distal radial fractures in adults (Review) Copyright 2008 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
TABLE OF CONTENTS HEADER . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ABSTRACT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . PLAIN LANGUAGE SUMMARY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . BACKGROUND . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . OBJECTIVES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . METHODS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . RESULTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . DISCUSSION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . AUTHORS CONCLUSIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ACKNOWLEDGEMENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . REFERENCES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . CHARACTERISTICS OF STUDIES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . DATA AND ANALYSES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Analysis 1.1. Comparison 1 External xation versus plaster cast, Outcome 1 Functional grading: not excellent. . . Analysis 1.2. Comparison 1 External xation versus plaster cast, Outcome 2 Functional grading: not excellent. Worst and best case scenarios sensitivity analyses. . . . . . . . . . . . . . . . . . . . . . . . . . Analysis 1.3. Comparison 1 External xation versus plaster cast, Outcome 3 Functional grading: fair or poor. . . . Analysis 1.4. Comparison 1 External xation versus plaster cast, Outcome 4 Subjective and objective functional evaluation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Analysis 1.5. Comparison 1 External xation versus plaster cast, Outcome 5 Upper extremity function part of Musculoskeletal Function Assessment tool (0 to 100: maximum disability). . . . . . . . . . . . . Analysis 1.6. Comparison 1 External xation versus plaster cast, Outcome 6 Difculties in activities of daily living. . Analysis 1.7. Comparison 1 External xation versus plaster cast, Outcome 7 Job change because of injury. . . . . Analysis 1.8. Comparison 1 External xation versus plaster cast, Outcome 8 Mass grip strength (% of normal side). . Analysis 1.9. Comparison 1 External xation versus plaster cast, Outcome 9 Grip, chuck and pinch strengths (injured normal side): units not given. . . . . . . . . . . . . . . . . . . . . . . . . . . . . Analysis 1.10. Comparison 1 External xation versus plaster cast, Outcome 10 Maximal voluntary contraction: injured uninjured side (Newtons). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Analysis 1.11. Comparison 1 External xation versus plaster cast, Outcome 11 Persistent pain (1 year & 7 years). . . Analysis 1.12. Comparison 1 External xation versus plaster cast, Outcome 12 Pain (6 months). . . . . . . . Analysis 1.13. Comparison 1 External xation versus plaster cast, Outcome 13 Range of movement at 1 year (% of normal side). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Analysis 1.14. Comparison 1 External xation versus plaster cast, Outcome 14 Range of movement at 2 years (injured normal side). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Analysis 1.15. Comparison 1 External xation versus plaster cast, Outcome 15 Range of movement at 1 year. . . . Analysis 1.16. Comparison 1 External xation versus plaster cast, Outcome 16 Range of movement at 7 years. . . . Analysis 1.17. Comparison 1 External xation versus plaster cast, Outcome 17 Complications. . . . . . . . . Analysis 1.18. Comparison 1 External xation versus plaster cast, Outcome 18 Reex sympathetic dystrophy - exploratory analysis. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Analysis 1.19. Comparison 1 External xation versus plaster cast, Outcome 19 Cosmetic deformity. . . . . . . Analysis 1.20. Comparison 1 External xation versus plaster cast, Outcome 20 Patient dissatised with wrist. . . . Analysis 1.21. Comparison 1 External xation versus plaster cast, Outcome 21 Anatomical grading: not excellent. . Analysis 1.22. Comparison 1 External xation versus plaster cast, Outcome 22 Anatomical grading: fair or poor. . . Analysis 1.23. Comparison 1 External xation versus plaster cast, Outcome 23 Anatomical displacement. . . . . Analysis 1.24. Comparison 1 External xation versus plaster cast, Outcome 24 Anatomical measurements. . . . . Analysis 1.25. Comparison 1 External xation versus plaster cast, Outcome 25 Structural deformity. . . . . . . APPENDICES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . FEEDBACK . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . WHATS NEW . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . HISTORY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . CONTRIBUTIONS OF AUTHORS . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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DECLARATIONS OF INTEREST SOURCES OF SUPPORT . . . NOTES . . . . . . . . . . INDEX TERMS . . . . . .
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[Intervention Review]
External xation versus conservative treatment for distal radial fractures in adults
Helen HG Handoll1 , James S Huntley2 , Rajan Madhok3
1 Centre
for Rehabilitation Sciences (CRS), Research Institute for Health Sciences and Social Care, University of Teesside, Middlesborough, UK. 2 University Department of Orthopaedic Surgery, Royal Inrmary of Edinburgh, Edinburgh, UK. 3 Cochrane Bone, Joint and Muscle Trauma Group, University of Manchester, Manchester, UK
Contact address: Helen HG Handoll, Centre for Rehabilitation Sciences (CRS), Research Institute for Health Sciences and Social Care, University of Teesside, School of Health and Social Care, Middlesborough, Tees Valley, TS1 3BA, UK. h.handoll@tees.ac.uk. H.Handoll@ed.ac.uk. Editorial group: Cochrane Bone, Joint and Muscle Trauma Group. Publication status and date: Edited (no change to conclusions), published in Issue 4, 2008. Review content assessed as up-to-date: 16 May 2007. Citation: Handoll HHG, Huntley JS, Madhok R. External xation versus conservative treatment for distal radial fractures in adults. Cochrane Database of Systematic Reviews 2007, Issue 3. Art. No.: CD006194. DOI: 10.1002/14651858.CD006194.pub2. Copyright 2008 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
ABSTRACT Background Fracture of the distal radius (broken wrist) is a common clinical problem. It can be treated conservatively, usually involving wrist immobilisation in a plaster cast, or surgically. A key method of surgical xation is external xation. Objectives To evaluate the evidence from randomised controlled trials comparing external xation with conservative treatment for fractures of the distal radius in adults. Search strategy We searched the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register (September 2006), the Cochrane Central Register of Controlled Trials, MEDLINE, EMBASE and other databases, conference proceedings and reference lists of articles. No language restrictions were applied. Selection criteria Randomised or quasi-randomised controlled clinical trials involving adults with a fracture of the distal radius, which compared external xation with conservative treatment. Data collection and analysis After independent study selection by all review authors, two authors independently assessed the included trials. Independent data extraction of new trials was performed by two authors. Pooling of data was undertaken where appropriate. Main results Fifteen heterogeneous trials, involving 1022 adults with dorsally displaced and potentially or evidently unstable distal radial fractures, were included. While all trials compared external xation versus plaster cast immobilisation, there was considerable variation especially in
External xation versus conservative treatment for distal radial fractures in adults (Review) Copyright 2008 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. 1
terms of patient characteristics and interventions. Methodological weaknesses among these trials included lack of allocation concealment and inadequate outcome assessment. External xation maintained reduced fracture positions (redisplacement requiring secondary treatment: 7/356 versus 51/338 (data from 9 trials); relative risk 0.17, 95% condence interval 0.09 to 0.32) and prevented late collapse and malunion compared with plaster cast immobilisation. There was insufcient evidence to conrm a superior overall functional or clinical result for the external xation group. External xation was associated with a high number of complications, such as pin-track infection, but many of these were minor. Probably, some complications could have been avoided using a different surgical technique for pin insertion. There was insufcient evidence to establish a difference between the two groups in serious complications such as reex sympathetic dystropy: 25/384 versus 17/347 (data from 11 trials); relative risk 1.31, 95% condence interval 0.74 to 2.32. Authors conclusions There is some evidence to support the use of external xation for dorsally displaced fractures of the distal radius in adults. Though there is insufcient evidence to conrm a better functional outcome, external xation reduces redisplacement, gives improved anatomical results and most of the excess surgically-related complications are minor.
PLAIN LANGUAGE SUMMARY External xation versus conservative treatment for distal radial fractures in adults In older people, a broken wrist (from a fracture at the lower end of one of the two forearm bones) can result from a fall onto an outstretched hand. Treatment usually involves reduction (putting the broken bone back into position) and immobilising the wrist in a plaster cast (conservative treatment). Surgery may be considered for more seriously displaced fractures. One type of surgery is external xation, in which metal pins are driven into bone, generally via small skin incisions, on either side of the fracture. These pins are then xed externally by incorporation into a plaster cast or securing into the frame of an external xator. The external component holds the bony fragments in position while the bone heals. This review looked at the evidence from randomised controlled trials comparing external xation with conservative treatment. Fifteen trials, involving 1022 adults with potentially or evidently unstable fractures, were included. While all trials compared external xation versus plaster cast immobilisation, there was considerable variation in their characteristics especially in terms of patient characteristics and the method of external xation. Weak methodology, such as using inadequate methods of randomisation and outcome assessment, means that the possibility of serious bias can not be excluded. The review found that external xation reduced fracture redisplacement that prompted further treatment and generally improved nal anatomical outcome. It appears to improve function too but this needs to be conrmed. The complications, such a pin tract infection, associated with external xation were many but were generally minor. Serious complications occurred in both groups. The review concludes that there is some evidence to support the use of external xation for these fractures.
BACKGROUND
Note: This is one of ve reviews that will cover all surgical interventions for treating distal radial fractures in adults. Each review will provide updated evidence for one of the several surgical categories that are presented together in the currently available review (Handoll 2003a). Following publication of the ve reviews, Handoll 2003a will be converted to an umbrella review summarising the evidence for surgical treatment for these fractures. Description of the condition: distal radial fracture in adults Fractures of the distal radius, often referred to as wrist fractures,
are common in both children and adults. They are usually dened as occurring in the distal radius within three centimetres of the radiocarpal joint, where the lower end of the radius interfaces with two (the lunate and the scaphoid) of the eight bones forming the carpus (the wrist). The majority are closed injuries, the overlying skin remaining intact. In this review, we consider the treatment of distal radial fracture in adults only, in whom they are one of the most common fractures, predominantly in white and older populations in the developed world (Sahlin 1990; Singer 1998; Van Staa 2001). In women, the
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incidence of these fractures increases with age, starting at around 40 years. Before this age, the incidence is higher in men (Singer 1998). In contrast, between 60 to 94 years of age, females predominate. A recent multi-centre study in the United Kingdom of patients aged 35 years and above with Colles fracture (see below) reported an annual incidence of 9/10,000 in men and 37/10,000 in women (ONeill 2001). Young adults usually sustain this injury as a result of high-energy trauma, such as a trafc accident. In older adults, especially females, the fracture more often results from low-energy or moderate trauma, such as falling from standing height. This reects the greater fragility of the bone, resulting from osteoporosis. It has been estimated that, at 50 years of age, a white woman in the USA or Northern Europe has a 15% lifetime risk of a distal radius fracture whereas a man has a lifetime risk of just over two per cent (Cummings 1985). More recent estimates (Van Staa 2001) of lifetime risk of radius or ulna fracture at 50 years of age are similar: 16.6% for women versus 2.9% for men. Distal radial fractures are usually treated on an outpatient basis. It is estimated that around 20% of patients (mainly older people) require hospital admission (Cummings 1985; ONeill 2001). This gure includes all people receiving surgery. Classication Surgeons have classied fractures by anatomical conguration and fracture pattern, to help in their management. Simple classications were based on clinical appearance and often named after those who described them. In the distal radius, the term Colles fracture is still used for a fracture in which there is an obvious and typical clinical deformity (commonly referred to as a dinner fork deformity) - dorsal displacement, dorsal angulation, dorsal comminution (fragmentation), and radial shortening. The introduction of X-rays and other imaging methods made it clear that the characteristic deformity may be associated with a range of different fracture patterns, which may be important determinants of outcome, and therefore the way in which treatment is conducted. For example, the fracture through the distal radius may be extra-articular (leaving the articular surface of the radius intact) or intra-articular (the articular surface is disrupted, sometimes in a complex manner). Numerous classications have been devised to dene and group different fracture patterns (Chitnavis 1999). One of the most commonly used is that of Frykman which distinguishes between extra-articular fractures and intra-articular fractures of the radiocarpal and radio-ulnar joints, and the presence or absence of an associated distal ulnar (ulnar styloid) fracture ( Frykman 1967). Another commonly used system is the AO (Arbeitsgemeinschaft fur Osteosynthesefragen) system (Muller 1991) which divides the fractures into three major groups: group A (extra-articular), group B (simple/partial intra-articular), and group C (complex/complete intra-articular). These three groups are then subdivided, yielding 27 different fracture types. Other classica-
tion systems have attempted to link fracture type more directly with fracture management. For instance, Cooney 1993 proposed a Universal Classication based on fracture displacement, articular involvement, reducibility (whether the fracture can be reduced; that is whether the bone fragments can be put back in place) and stability (whether, once reduced, the fragments will remain so). Description of the intervention: external xation In the last century, most distal radial fractures in adults were treated conservatively, by reduction of the fracture when displaced, and stabilisation in a plaster cast or other external brace. The results of such treatment, particularly in older people with bones weakened by osteoporosis, are not consistently satisfactory (Handoll 2003b). This has resulted in attempts to develop other strategies involving surgery aimed at more accurate reduction and more reliable stabilisation. One such strategy is external xation (Capo 2006; Fernandez 1999; Pennig 1996). Typically this is a closed, minimally invasive method where, in contrast to open surgery, the fractured bone ends are not exposed to direct view. Metal pins or screws are driven into bone, generally via small incisions of the skin and after drilling, on either side of the fracture. These pins are then xed externally, such as by incorporation into a plaster cast or securing into an external xator frame. The external component stabilises or xes the reduced fracture. Fracture reduction or alignment of the bony fragments is generally achieved by closed means, often in the process of applying external xation. Reduction may be assisted by the application of a percutaneously (through the skin) inserted wire as a joy stick to move the bony fragments back into place. There is considerable variety in the techniques (such as for pin insertion and placement) and devices used for external xation. Some devices are non-bridging (of the wrist joint) in that the distal pins are placed in the distal radial fragment. In bridging xators, the distal pins are placed in one or more metacarpal bones. Some xators are linear or uniplanar, whereas others are multiplanar. In addition, some bridging xators have an articulation (e.g. a ball joint) that allows limited wrist movement. The duration and extent of immobilisation with external xation also vary. In some cases, external xation may be augmented by additional methods of fracture xation. In this review, we include only trials using supplementary percutaneous pinning. This involves extra pins or wires being inserted through the skin and used to x or support distal radial fragments. Complications Complications from this injury are diverse and frequent (Altissimi 1986; Atkins 1989; Cooney 1980). Some are associated with the injury itself. As well as concomitant injuries to soft tissues, fracture displacement can further compromise blood vessels, tendons and nerves, with median nerve dysfunction being the most common complication (Belsole 1993). Late complications include mid3
carpal instability and post-traumatic arthritis which can occur several months or years after injury (Knirk 1986; Taleisnik 1984). Complications can also result from treatment interventions and include residual nger stiffness, which may be due to faulty application of plaster casts (Gartland 1951), pin track infection, soft tissue injury including tendon rupture, and additional fractures. Complex regional pain syndrome type 1, often termed reex sympathetic dystrophy (RSD), but also referred to as algodystrophy, Sudecks atrophy and sometimes shoulder-hand syndrome ( Fernandez 1996) is a major complication (Atkins 2003) requiring many months of physiotherapy to alleviate symptoms (pain and tenderness, impairment of joint mobility, swelling, dystrophy, vasomotor instability) in serious cases. The pathology of RSD remains unclear. Why it is important to do this review External xation is one of the main methods for surgical xation of distal radial fractures. A key question is whether it produces superior results, particularly in terms of function, to conservative treatment. The answer to this question is likely to depend particularly on fracture conguration and bone quality. The issue of what is the best method of external xation will be addressed in a separate review (Handoll 2007).
Types of studies Any randomised or quasi-randomised (method of allocating participants to a treatment which is not strictly random e.g. by date of birth, hospital record number, alternation) controlled clinical trial comparing external xation with conservative methods for treating distal radial fractures in adults was considered.
Types of participants Included were patients of either sex who have completed skeletal growth, with a fracture of the distal radius. External xation may be considered as primary treatment or take place after the failure of initial conservative management, generally within two to three weeks. Augmented external xation in the form of supplementary percutaneous pinning was also included. Trials with a mixed population of adults and children were included provided the proportion of children was clearly small (< 5%); otherwise they would have been excluded unless separate data for adults were obtained. We considered it unlikely that we would nd trials comparing external xation with conservative treatment for rarer fracture patterns such as the Bartons fractures (Smith 1988) that are inherently unstable and generally considered not to be amenable to conservative or external xation. Nonetheless, if found, trials with these types of fractures would have been considered for inclusion, and separate subgroup data sought for mixed fracture populations.
OBJECTIVES
We aimed to evaluate the evidence from randomised controlled trials for the use of external xation for fractures of the distal radius in skeletally mature people. We compared the relative effects (benets and harms) of any method of external xation versus conservative treatment involving plaster or brace use in adults with these injuries. Also considered was augmented external xation where supplementary percutaneous (through the skin) pinning was used to x or support distal radial fragments. We considered these effects primarily in terms of patient-assessed functional outcome and satisfaction, and other measures of function and impairment, pain and discomfort, the incidence of complications, anatomical deformity and use of resources. Our plan to study the outcomes in different age groups and for different fracture types, especially whether they are extra-articular or intra-articular, was thwarted by the variation in the trial characteristics. Types of interventions Randomised comparisons of surgical interventions involving external xation by itself or with supplementary percutaneous pinning versus conservative interventions such as plaster cast immobilisation. We excluded trials comparing different methods, including techniques and devices, of external xation; or trials comparing external xation with other methods of surgical xation, such as percutaneous pinning, or trials evaluating the use of supplementary methods, such as bone grafts and substitutes, other than percutaneous pinning, to external xation compared with conservative treatment. These comparisons will be covered in other reviews, including one covering the use of bone grafts and substitutes.
Types of outcome measures Our primary outcome of choice would be the number of people with an uncomplicated and speedy restoration of a pain-free fullyfunctioning wrist and arm with acceptable anatomic restoration and appearance. However, compatible with the general assessment and presentation of outcome within the orthopaedic literature, we report outcome in the following four categories. Primary outcomes (1) Functional outcome and impairment
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METHODS
Criteria for considering studies for this review
Patient functional assessment instruments such as Short Form-36 (SF-36), the Disability of the Arm, Shoulder, and Hand questionnaire (DASH) and the Patient-Rated Wrist Evaluation (PRWE) (MacDermid 2000) Return to previous occupation, including work, and activities of daily living Grip strength Pain Range of movement (wrist and forearm mobility): range of movement for the wrist is described in terms of six parameters: exion (ability to bend the wrist downwards) and extension (or upwards); radial deviation (ability to bend the wrist sideways on the thumb side) and ulnar deviation (on the little nger side); and pronation (ability to turn the hand so that the palm faces downwards) and supination (palm faces upwards) (2) Clinical outcome Residual soft tissue swelling Early and late complications associated with distal radial fractures or their treatment, including reex sympathetic dystrophy (RSD) and post traumatic osteoarthritis Cosmetic appearance Patient satisfaction with treatment Secondary outcomes (3) Anatomical outcome (anatomical restoration and residual deformity) Radiological parameters include radial length or shortening and shift, dorsal angulation, radial inclination or angle, ulnar variance, and for intra-articular fractures: step off and gap deformity of the articular surface (Fernandez 1996; Kreder 1996a). Composite measures include malunion and total radiological deformity. Denitions of four of the most commonly reported radiological parameters are presented in Table 1. Table 1. Denitions of key radiological parameters Parameter Denition Normal value
Dorsal angulation (dorsal or volar or pal- Angle between a) the line which connects Palmar or volar tilt: approximately 11-12 mar tilt) the most distal points of the dorsal and degrees. volar cortical rims of the radius and b) the line drawn perpendicular to the longitudinal axis of the radius. Side view of wrist. Radial length Distance between a) a line drawn at the tip Approximately 11-12 mm. of the radial styloid process, perpendicular to the longitudinal axis of the radius and b) a second perpendicular line at the level of the distal articular surface of the ulnar
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Table 1. Denitions of key radiological parameters
(Continued)
head. Frontal view. Radial angle or radial inclination Angle between a) the line drawn from the Approximately 22-23 degrees. tip of the radial styloid process to the ulnar corner of the articular surface of the distal end of the radius and b) the line drawn perpendicular to the longitudinal axis of the radius. Frontal view. Vertical distance between a) a line drawn Usually negative variance (e.g. -1 mm) or parallel to the proximal surface of the lu- neutral variance. nate facet of the distal radius and b) a line parallel to the articular surface of the ulnar head. We also searched Current Controlled Trials at www.controlledtrials.com (accessed September 2006) and the UK National Research Register at www.update-software.com/national/ (up to Issue 3, 2006) for ongoing and recently completed trials.
Ulnar variance
(4) Resource use
Hospital stay, number of outpatient attendances and other costs. Timing of outcome assessment Results were usually collected for the nal follow-up time for which these are available. However, we also noted interim results where a marked and important difference in the timing of recovery had occurred. Searching other resources We searched the reference list of articles. We also included the ndings from handsearches of the British Volume of the Journal of Bone and Joint Surgery supplements (1996 onwards) and abstracts of the American Society for Surgery of the Hand annual meetings (2000 to 2006: www.assh.org/), the American Orthopaedic Trauma Association annual meetings (1996 to 2005: http:// www.hwbf.org/ota/am/) and American Academy of Orthopaedic Surgeons annual meeting (2004 to 2006: http://www.aaos.org/ education/anmeet/libscip.asp). We also included handsearch results from the nal programmes of SICOT (1996 & 1999) and SICOT/SIROT (2003), and the British Orthopaedic Association Congress (2000, 2001, 2002 and 2003), and various issues of Orthopaedic Transactions and Acta Orthopaedica Scandinavica Supplementum. We also scrutinised weekly downloads of Fracture articles in new issues of 17 journals (Acta Orthop Scand; Am J Orthop; Arch Orthop Trauma Surg; Clin J Sport Med; Clin Orthop; Emerg Med Clin North Am; Foot Ankle Int; Injury; J Accid Emerg Med; J Am Acad Orthop Surg; J Arthroplasty; J Bone Joint Surg Am; J Bone Joint Surg Br; J Foot Ankle Surg; J Orthop Trauma; J Trauma; Orthopedics) from AMEDEO (www.amedeo.com).
Search methods for identication of studies
Electronic searches We searched the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register (September 2006), the Cochrane Central Register of Controlled Trials (in The Cochrane Library 2006, Issue 3) (see Appendix 1), MEDLINE (1966 to September week 1 2006), EMBASE (1988 to 2006 week 36), CINAHL (1982 to September week 2 2006). No language restrictions were applied. In MEDLINE (OVID-WEB) the search strategy was combined with all three sections of the optimal MEDLINE search strategy for randomised trials (Higgins 2005) (see Appendix 2). Similar search strategies were used for EMBASE (OVID-WEB) and CINAHL (OVID-WEB) (see Appendix 3).
Data collection and analysis

Selection of studies All review authors independently assessed potentially eligible trials for inclusion using a pre-piloted form. Any disagreement was resolved by discussion. Data extraction and management Using a data extraction form, two of the review authors (HH and JH) independently extracted trial details and data for new trials, and one author (HH) repeated data extraction of trials already included in Handoll 2003a and checked for consistency with her previous data extraction. HH entered the data into RevMan. Any disagreements were resolved by discussion. When appropriate, extraction of results from graphs in trial reports was performed where data were not provided in the text or tables. We contacted trialists of trials not reported in full journal publications for additional information or data. Contact with other trial authors was dictated by the vintage of the publication, a general impression of the expected gain, and anticipated or known difculty in locating trial authors. Results were collected for the nal follow-up time for which these were available. We also noted instances where clinically important differences had been reported at intermediate follow-up assessments. Assessment of methodological quality In this review, risk of bias is implicitly assessed in terms of methodological quality. Two of the review authors (HH and JH) independently assessed methodological quality of the newly included trials using a prepiloted form. One author (HH) repeated her assessment of the trials already included in Handoll 2003a. All disagreements were resolved by discussion. Titles of journals, names of authors or supporting institutions were not masked at any stage. A modication of the quality assessment tool used in the current umbrella review was used. Instead of scores, each item was graded based on whether the quality criterion was met: Y (met), ? (possibly or only partially met) or N (not met). The rating scheme covering 11 aspects of trial validity plus brief notes of coding guidelines for selected items are given in Table 2. Table 2. Methodological quality assessment scheme Items Scores Notes
(1) Was the assigned treatment adequately Y = method did not allow disclosure of as- Cochrane code (see Handbook): Clearly concealed prior to allocation? signment. yes = A; Not sure = B; Clearly no = C. ? = small but possible chance of disclosure of assignment or unclear. N = quasi-randomised, or open list or tables.
Table 2. Methodological quality assessment scheme
(Continued)
(2) Were the outcomes of participants who Y = withdrawals well described and acwithdrew described and included in the counted for in analysis. analysis (intention-to-treat)? ? = withdrawals described and analysis not possible, or probably no withdrawals. N = no mention, inadequate mention, or obvious differences and no adjustment. (3) Were the outcome assessors blinded to Y = effective action taken to blind assessors. treatment status? ? = small or moderate chance of unblinding of assessors, or some blinding of outcomes attempted. N = not mentioned or not possible. (4) Were important baseline characteristics Y = good comparability of groups, or conreported and comparable? founding adjusted for in analysis. ? = confounding small, mentioned but not adjusted for, or comparability reported in text without conrmatory data. N = large potential for confounding, or not discussed. (5) Were the trial participants blind to as- Y = effective action taken to blind particisignment status after allocation? pants. ? = small or moderate chance of unblinding of participants. N = not possible, or not mentioned (unless double-blind), or possible but not done. (6) Were the treatment providers blind to Y = effective action taken to blind treatment assignment status? providers. ? = small or moderate chance of unblinding of treatment providers. N = not possible, or not mentioned (unless double-blind), or possible but not done. (7) Were care programmes, other than the Y = care programmes clearly identical. trial options, identical? ? = clear but trivial differences, or some evidence of comparability. N = not mentioned or clear and important differences in care programmes. (8) Were the inclusion and exclusion crite- Y = clearly dened (including type of fracria for entry clearly dened? ture). ? = inadequately dened. N = not dened. (9) Were the outcome measures used clearly Y = clearly dened. dened? ? = inadequately dened. N = not dened.
Although many characteristics including hand dominance are important, the principal confounders are considered to be age, gender, type of fracture.
Examples of clinically important differences in other interventions are: time of intervention, duration of intervention, anaesthetic used within broad categories, operator experience, difference in rehabilitation.
Table 2. Methodological quality assessment scheme
(Continued)
(10) Were the accuracy and precision, Y = optimal. with consideration of observer variation, of ? = adequate. the outcome measures adequate; and were N = not dened, not adequate. these clinically useful and did they include active follow up? (11) Was the timing (e.g. duration of Y = optimal. (> 1 year) surveillance) clinically appropriate? ? = adequate. (6 months - 1 year) N = not dened, not adequate. (< 6 months) Measures of treatment effect Where available, quantitative data, both dichotomous and continuous, for the outcome measures listed above (see Types of outcome measures) are presented in the analyses. Relative risks and 95% condence intervals were calculated for dichotomous outcomes and mean differences and 95% condence intervals calculated for continuous outcomes. Unit of analysis issues No unit of analysis issues arose in this review. Dealing with missing data Where appropriate, we have performed intention-to-treat analyses to include all people randomised to the intervention groups. To a limited extent, we have investigated the effect of drop outs and exclusions by conducting worse and best scenario analyses. We were alert to the potential mislabeling or non identication of standard errors for standard deviations. Unless missing standard deviations could be derived from condence interval data, we did not assume values in order to present these in the analyses. Assessment of heterogeneity Heterogeneity was assessed by visual inspection of the forest plot (analysis) along with consideration of the test for heterogeneity and the I statistic (Higgins 2003). Assessment of reporting biases There were insufcient data to assess publication bias; for example, by preparing a funnel plot. Data synthesis (meta-analysis) Table 3. Categories of effectiveness (denitions) Rank Category Denition When considered appropriate, results of comparable groups of trials were pooled. Initially we used the xed-effect model and 95% condence intervals. We also considered using the random-effects model, especially where there was unexplained heterogeneity. Subgroup analysis and investigation of heterogeneity There were no data available to carry out our pre-specied subgroup analyses by age, gender and type of fracture (primarily, extraarticular versus intra-articular fractures). Presentation in separate subgroups was also considered where there was a fundamental difference in the method of external xation (such as bridging versus non-bridging external xation; the use of supplementary percutaneous pinning), but considered inappropriate. To test whether the subgroups are statistically signicantly different from one another, we tested the interaction using the technique outlined by Altman and Bland (Altman 2003).
Sensitivity analysis There were no data available to carry out our pre-specied sensitivity analyses examining various aspects of trial and review methodology, including the study quality (specically allocation concealment, outcome assessor blinding and reportage of surgical experience). Interpretation of the evidence We graded the ndings of the treatment comparison(s) according to the six categories of effectiveness used by contributors to Clinical Evidence (BMJ 2006) (see Table 3) to assist our interpretation of the evidence.
Table 3. Categories of effectiveness (denitions)
(Continued)
Benecial
Interventions for which effectiveness has been demonstrated by clear evidence from randomised controlled trials, and for which expectation of harms is small compared with the benets. Interventions for which effectiveness is less well established than for those listed under benecial. Interventions for which clinicians and patients should weigh up the benecial and harmful effects according to individual circumstances and priorities. Interventions for which there is currently insufcient data or data of inadequate quality. Interventions for which lack of effectiveness is less well established than for those listed under likely to be ineffective or harmful Interventions for which ineffectiveness or harmfulness has been demonstrated by clear evidence. All of the included studies were fully reported in medical journals. Six of the included trials were initially located by handsearching. The rest were located in the following ways: The Cochrane Bone, Joint and Muscle Trauma Group Specialist Register (2); MEDLINE (5); PubMed (1) and bibliography checking (1). A translation from Chinese was obtained for Zheng 2003. Details of the methods, participants, interventions and outcome measures of individual trials are provided in the Characteristics of included studies table. Setting The publication dates of the main reports of these trials span 18 years; Pring 1988 being the earliest. Each trial took place in one of nine countries: Canada (1 trial), China (1), India (1), Israel (1), New Zealand (1), Spain (1), Sweden (2), The Netherlands (2), and the UK (5). All were all single-centre studies apart from Kreder 2006, which had three centres. Most were conducted in teaching hospitals. Participants Age and gender The 15 included trials involved a total of 1022 participants. Five trials (Horne 1990; Howard 1989; Jenkins 1989; Roumen 1991; Stein 1990) provided no information on the gender composition of their study populations. For the rest, the percentage of females ranged from 17% (Rodriguez-Merchan 92) to 91% (Hegeman 2004). The mean ages of the trial populations ranged from 36 years (Rodriguez-Merchan 92) to 72 years (Horne 1990). Aside
Likely to be benecial
Trade off between benets and harms
Unknown effectiveness
Unlikely to be benecial
Likely to be ineffective or harmful
RESULTS Description of studies

See: Characteristics of included studies; Characteristics of excluded studies. Results of the search The search for trials predated the development of this review, which is essentially a reworked update of part of a previously published review (Handoll 2003a) covering all surgical intervention for these fractures. We have not documented the numbers of references retrieved by electronic searches; updates of MEDLINE, EMBASE and CINAHL are now generated on a weekly basis. Of 21 potentially eligible studies put forward for study selection, 15 were included, ve were excluded and one is in Studies awaiting assessment. Twelve of the included trials were previously included in Handoll 2003a; this includes Young 2003, whose study ID has been changed to reect the identication of a full report. The three additional trials (Hegeman 2004; Kreder 2006; Zheng 2003) have been included in the current review; the Kreder trial was listed as ongoing in Handoll 2003a. Included studies
10
from restricting trial participation to people over 55 years, Roumen 1991 provided no information on age. Only the age range (18 to 52 years) of the study population was provided for Zheng 2003. It is clear that the vast majority of participants in the included trials were skeletally mature: in particular, three trials (Kapoor 2000; Kreder 2006; Young 2003) excluded children either by explicitly setting a minimum age limit or stipulating that the participants should be adult or skeletally mature. Four trials (Hegeman 2004; Horne 1990; Lagerstrom 1999; Roumen 1991) further restricted the trial population to more mature adults: above 55, 60, 45 and 55 years respectively. Upper age limits were applied in eight trials (Abbaszadegan 1990: 75 years; Hegeman 2004: 80 years; Howard 1989: 75 years; Jenkins 1989: 65 years; Kreder 2006: 75 years; Lagerstrom 1999: 75 years; Rodriguez-Merchan 92: 45 years; Young 2003: 75 years). Overall the trials in terms of age and gender of their study populations appear to fall into three categories: Four trials (Jenkins 1989; Kapoor 2000; RodriguezMerchan 92; Zheng 2003) had predominantly younger adult populations. There were more males than females in three of these trials; no data on gender mix were provided for Jenkins 1989. Seven trials (Abbaszadegan 1990; Howard 1989; Kreder 2006; McQueen 1996; Pring 1988; Stein 1990; Young 2003) included a general adult population, albeit some with an upper age limit (generally 75 years). The majority of participants were women in ve of these trials; no data on gender mix were provided for Howard 1989 and Stein 1990. Four trials (Hegeman 2004; Horne 1990; Lagerstrom 1999; Roumen 1991) restricted their population to older people. The majority of participants in three of these trials were women; no data on gender mix were provided for Horne 1990. Types of fractures Two trials (McQueen 1996; Roumen 1991) recruited people whose fractures had redisplaced by two weeks, whereas the other 13 trials involved primary treatment of people with acute fractures. No trial referred to people with open fractures and it is likely that all fractures were closed; this was explicit in Kreder 2006 and Zheng 2003. Several descriptions were used to dene the types of fracture in the included trials. Fourteen trials gave explicit reference to the inclusion of dorsally displaced or Colles fractures (including the use of Olders classication: Older 1965) or presented radiological results indicating that fractures were dorsally displaced. Kapoor 2000 included both dorsally and volarly displaced intra-articu-
lar fractures. Six trials (Horne 1990; Jenkins 1989; Kapoor 2000; Pring 1988; Rodriguez-Merchan 92; Zheng 2003) provided no criteria of the extent of the displacement required for trial entry. Kreder 2006 set an upper limit of the extent of dorsal angulation and metaphyseal comminution as well as stipulating joint congruity; this reected the inclusion criteria of another concurrent trial involving more displaced fractures (Kreder 2005). Only intra-articular fractures were included in six trials (Hegeman 2004; Kapoor 2000; Lagerstrom 1999; Rodriguez-Merchan 92; Roumen 1991; Stein 1990). Both intra-articular and extra-articular fractures were clearly included in the remaining trials except Howard 1989; however, some, if not most, of the severely displaced and comminuted Colles fractures of this trial were intra-articular. Of the 13 trials applying or reporting fracture type according to an established classication system, two trials grouped fractures according to more than one classication system. Seven trials referred to the Frykman system, four trials to the AO system and two trials to Olders system. Zheng 2003 categorised their fractures according to the universal system (Cooney 1993), which also includes whether the fractures were reducible. Interventions All 15 trials compared external xation with plaster cast immobilisation. There was, however, considerable variety in the devices used for external xation and in surgical techniques such as methods of reduction, pin insertion and pin placement. The duration and extent of immobilisation in both the external xation and conservative treatment groups also varied among trials. One trial ( Pring 1988) used pins incorporated into plaster. One trial (Jenkins 1989) applied a (multiplanar) xator that did not bridge the wrist joint. Linear or uniplanar xators which bridged the wrist joint were clearly used in eight trials (Abbaszadegan 1990; Horne 1990; Lagerstrom 1999; McQueen 1996; Rodriguez-Merchan 92; Stein 1990; Young 2003; Zheng 2003) and non-linear or multi-planar xators used in three trials (Howard 1989; Kapoor 2000; Roumen 1991). The congurations of the external xator frames used in Hegeman 2004 and Kreder 2006 were not clear, but were probably uniplanar. Explicit use of optional percutaneous K-wire xation to stabilise the fracture was referred to in three trials (Kreder 2006; Rodriguez-Merchan 92; Zheng 2003). In Jenkins 1989, the distal wires were orientated so that they transxed comminuted fractures (such as die punch fractures) of the distal fragment before the external xator was assembled. A concise summary of the participants, fracture type, timing and details of the interventions for the 15 trials is given in Table 4.
Table 4. Key characteristics of participants, fractures and interventions
11
(Continued)
Study ID
Participants gender, age)
(N, Fracture Type/Clas- Timing of surgery/ Fixation sication Reduction
Conservative treatment
Abbaszadegan 1990 47; 77% female; Displaced (5+ mm After closed reducmean age 63 years. radial short- tion and plaster cast ening); extra-articu- for 1-3 days. lar and intra-articular. Colles. Older 3 & 4. Hegeman 2004 32; 91% female; Displaced (> 10 demean age 70 years. grees dorsal angulation and < 20 degrees radial inclination and > 3 mm positive ulnar variance) unstable intraarticular. AO C2 or C3. Timing of intervention: not stated, but after X-ray examination. Reduction (probably closed).
Skin incision for Closed reduction pins. Trans-articu- and plaster cast for 4 lar xation. External weeks Hoffman xator for 4 weeks.
No details of pin insertion. Trans-articular xation. Hoffmann II compact external xator for 6 weeks
Closed reduction and below elbow plaster cast for 6 weeks
Horne 1990
37; % female un- Displaced extra-ar- Not stated but day known; mean age 72 ticular and intra-ar- care surgery after years. ticular. (Colles im- presentation to fracplied) Frykman 1, 2, ture clinic. Closed 3, 4, 5 and 8. reduction.
Stab Closed reduction incision for pins. and plaster cast for 5 Trans-articular xa- weeks. tion. Modied AO tubular external xator for 5 weeks. Careful pin insertion. Trans-articular xation. MediumC-Hoffman external xator for 5 to 6 weeks. Closed reduction and below elbow plaster cast for 5 to 6 weeks.
Howard 1989
50; % female un- Severely disknown; mean age 47 placed (30 degrees years. dorsal angulation / > 10 mm radial shortening) comminuted Colles fracture. Intra-articular fractures included.
Not stated, usually next available trauma list. Reduction during external xation.
Jenkins 1989
153; % female un- Displaced. Extra-ar- Probably closed reknown; mean age 44 ticular and intra-ar- duction at fracture years. ticular. Colles. clinic. Operation on Frykman. day of injury or following day.
Stab incision for Closed reduction pins. Non-bridging and plaster cast for 4 xation (not across weeks. wrist joint). The distal wires transxed the comminuted (if present) distal radial fragment. AO/ASIF external mini-xator for 4 weeks.
12
(Continued)
Kapoor 2000
61 of 90 in comparison; 25% female; mean age of whole trial group was 39 years.
Displaced (dorsal or volar). All intra-articular. Frykman (3, 4, 7 and 8) and AO.
Not stated, but acute injury treatment. No details of reduction method.
No details of pin in- Closed reduction sertion. Trans-artic- and plaster cast for 6 ular xation. Roger to 7 weeks. and Anderson external xator, rigid frame, for 6 to 7 weeks. Skin incision for insertion of pins into radial shaft. Transarticular xation. Small AO xator for 6 to 8 weeks. Optional percutaneous K-wire xation: removed 4 to 6 weeks. Closed reduction and long arm splint for up to 2 weeks, then long arm cast which was reduced to a short arm cast at 3 to 4 weeks; removed 6 to 8 weeks.
Kreder 2006
113; 65% female; Displaced (but < 10 mean age 53 years. degrees dorsal tilt/ angulation) with metaphyseal comminution (< 1/3rd of radius diameter). Extra-articular and intra-articular (stable congruous joint). AO A and C. 35; 86% female; Displaced (10+ demean age 58 years. grees dorsal angulation / radial angulation; 3+ mm radial shortening) intra-articular Colles fracture. Frykman 5 to 8. 90 of 120 in comparison; 90% female; mean age 64 years.
Not stated but within 1 week of injury. Closed reduction under regional anaesthesia.
Lagerstrom 1999
Not stated, but probably acute. No details of reduction method.
No details of pin Below elbow plaster insertion. Light (in cast for 6 weeks. weight) non-cylindrical AO external xator for 6 weeks.
McQueen 1996
Redisplaced (> 10 Within 2 weeks Open incisions for Closed reduction degrees dorsal angu- from injury. Closed pin insertion. Trans- and plaster cast for 6 lation or > 3 mm reduction. articular xation. weeks. radial shortening). Pennig external xaAO types A and C tor for 6 weeks. Ball (extra-articular and joint released for intra-articular). limited wrist motion in 30 participants at 3 weeks. After accident and emergency attendance and closed reduction using Chinese nger traps. PerClosed reduction cutaneous pin inser- and forearm plaster tion. Trans-articular cast for 5 weeks. xation. Pins incorporated into plaster cast. Cast removed after 5 weeks.
Pring 1988
75; 81% female; Displaced mean age 62 years. Colles fracture. Extra-articular and intra-articular.
13
(Continued)
RodriguezMerchan 92
70; 17% female; Comminuted intra- Probably closed remean age 36 years. articular fractures. duction on rst day Frykman 3 to 8. after injury and operation then or next day.
Pins Closed reduction driven into bone. and forearm plaster Trans-articular xa- cast for 7 weeks. tion. Clyburn dynamic external xator for 7 weeks. Posterior splint applied for 3 weeks if joint disrupted. Optional K wire inserted for 3 weeks if joint unstable.
Rouman 1991
43; % female un- Redisplaced Colles At 2 weeks. Closed No details of pin Plaster cast continknown; age over 55 fracture reduction. insertion. Trans-ar- ued for 5 weeks. years. (>10 degrees dorsal ticular xation. Ace angulation or > 5 Colles external xamm radial shortentor for 5 weeks. ing). All intra-articular. Frykman (5 to 8) and Sarmiento. 62; % female un- Comminuted disknown; mean age 50 placed intra-articuyears. lar fractures. Older 3 and 4 (thus Colles). Not stated but after presentation to fracture clinic. Admission to hospital for 24 hours or day care facility for surgery. Closed reduction. Not stated. Closed reduction. Hospital admission for external xation. No details of pin insertion. Trans-articular xation likely. Small AO external tubular xator for 6 weeks. Closed reduction and above-elbow plaster cast for 6 weeks.
Stein 1990
Young 2002
125; 78% female; Displaced (> 10 demean age 57 years. grees dorsal angulation or > 2 mm radial shortening) distal radial fractures. Extra-articular and intra-articular. Colles. Frykman: all grades (18).
PercutaClosed reduction neous pin insertion and forearm plaster for 2nd metacarpal, cast for 6 weeks. direct vision for insertion into radial shaft. Trans-articular xation. Pennig external xator for 6 weeks. Ball joint released for limited wrist motion at 3 weeks. Pins inserted Closed reduction through skin inci- and forearm plaster sions. Trans-articu- cast for 6 weeks. lar xation. Small size Zhongjia SGDtype unilateral mul14
Zheng 2003
29; 48% female, Closed unstable disrange 18 - 52 years tal radial fracture. Universal classication (Cooney) 2B, 2C (extra-articular), 4B, 4C (intra-artic-
Not stated. Closed or open reduction. Participants were either outpatients or inpatients.
(Continued)
ular).
tifunctional external xator. Optional Kirschner wire for unstable fractures. Fixator made dynamic and K-wire removed from week 4. Fixator removed after 6 weeks.
Excluded studies Five studies were excluded for reasons stated in the Characteristics of excluded studies table. Four studies were found not to be randomised trials and there was insufcient information on one quasi-randomised trial (Sprenger 1988), published only as an abstract. (The latter trial appeared as an included trial in Handoll 2003a.) Ongoing studies No ongoing studies were identied. Studies awaiting assessment The possible inclusion of Moroni 2004 requires a response from the lead author concerning the numbers allocated to each group.
Risk of bias in included studies

The quality of trial methodology, judged using the 11 quality criteria listed in Table 2, is disappointing. Associated with this is a high potential for the key systematic biases (selection, performance, assessment and attrition) leading to questions about internal validity, and issues of clinical relevance and applicability or external validity. These will be considered further in the Discussion. The results, together with some notes on specic aspects, of the quality assessment for the individual trials are shown in Table 5. Information specic to the rst three items of the quality assessment is given in the methods sections of the Characteristics of included studies table. A summary of the results for individual items of quality assessment is given below. Table 5. Quality assessment results for individual trials (see Table 03 for scheme) Study ID Study ID Items and grades Item 1: Allocation concealment Item 2: Intention-totreat analysis Item 3: Outcome assesItems and grades Item 5: Participant blinding Item 6: Treatment provider blinding Items and grades Notes
Item 9: Well dened out- Comments and explanacome measures tions for specic items Item 10: Optimal outcome assessment
15
Table 5. Quality assessment results for individual trials (see Table 03 for scheme)
(Continued)
sor blinding Item 7: Identical care Item 4: Comparable programmes baseline characteristics Item 8: Clearly dened inclusion criteria
Item 11: Optimal timing of follow up (> 1 year) In brackets: date of last follow up; % lost to last follow up Y, ?, ? (1 year; 2%) Item 4: separate age, sex and type of fracture data not provided. Item 7: method(s) of anaesthesia not given.
Abbaszadegan 1990
?, Y, N, N
N, N, N, Y
Hegeman 2004
?, Y, N, Y
N, N, ?, Y
Y, ?, ? (1 year; 0%?)
Horne 1991
?, N, N, N
N, N, ?, ?
Y, N, N (4 - 15 months; Item 2: discrepancies in 22%) numbers followed up in the two groups. Item 4: baseline data not provided for all participants. Y, ?, Y (10 years; 20% or Item 2: although Y 22%) there were some data discrepancies between the two abstracts reporting the long-term follow up. Y, ?, Y (13 months; 19%) Item 4: There was a 10 year difference in the mean ages of the two groups (38 versus 48). Item 8: The maximum age differed between 65 in the Masters thesis and 60 in the 2 journal publications. Y, ?, Y (mean 4 years; Item 2: no mention of 33%) loss to follow up but fewer participants in the analyses at 4 years. Y, Y, Y (2 years; 25%) Item 7: regional aneasthesia was used in the external xation group and haematoma block in the plaster group.
Howard 1989
?, Y, N, ?
N, N, Y, Y
Jenkins 1989
N, ?, N, N
N, N, N, ?
Kapoor 2000
?, N, N, ?
N, N, N, ?
Kreder 2006
Y, Y, N, Y
N, N, ?, Y
16
Table 5. Quality assessment results for individual trials (see Table 03 for scheme)
(Continued)
Lagerstrom 1999
?, ?, N, N
N, N, Y, Y
Y, ?, Y (2 years; 6%)
Item 4: key patient characteristics were not split by group except for gender. There were males (5/18) in the external xation group but none (0/17) in the plaster group.
McQueen 1996 Pring 1988
?, Y, N, ? ?, N, N, ?
N, N, ?, Y N, N, ?, N
Y, ?, ? (1 year; 9%) Y, ?, ? (6 months; 12%) Item 2: 9 people from the plaster group were given external xation and reportedly analysed separately but no data were given. Item 1: though described as double-blind, no details were given of the method of randomisation. Item 2: It is possible that some patients who were lost to follow up (17) or had died (2) from the initial group of 126 people with displaced fractures would have be included in the trial should their fractures have redisplaced.
Rodriguez-Merchan 92
?, ?, N, ?
N, N, ?, Y
Y, ?, ? (1 year; 0%?)
Roumen 1991
?, N, N, N
N, N, N, Y
Y, ?, ? (6 months; 0%?)
Stein 1990
N, ?, N, N
N, N, N, Y
?, N, ? (6 months to 4 Item 10: The nal folyears; 0%?) low up of participants, recruited over a 4 year period, ranged from 6 months to 4 years. Y, ?, Y (7 years; 31%) Y, ?, ? (1 year; 0%?) Item 4: Insufcient information but also imbalance in number of males (5 versus 10).
Young 2003 Zheng 2003
?, Y, N, ? N, ?, N, N
N, N, ?, Y N, N, ?, ?
17
Allocation concealment (item 1) Only one trial (Kreder 2006), which used sealed opaque sequentially marked envelopes, was considered to have satised the criteria for secure allocation concealment. It was unclear whether allocation was concealed prior to randomisation in 11 trials. Three of these used envelopes (Hegeman 2004; McQueen 1996; Young 2003), one used a computer (Lagerstrom 1999) and seven trials provided no information (Abbaszadegan 1990; Horne 1990; Howard 1989; Kapoor 2000; Pring 1988; Rodriguez-Merchan 92; Roumen 1991). The three remaining trials used quasi-randomised methods based on dates of birth (Jenkins 1989), day of hospital admission (Stein 1990) and admission number (Zheng 2003). Intention-to-treat analysis (item 2) Clear statements of participant ow with evidence of intentionto-treat analysis were available for six trials (Abbaszadegan 1990; Hegeman 2004; Howard 1989; Kreder 2006; McQueen 1996; Young 2003). Failure to provide the numbers assigned to each group at randomisation, post-randomisation exclusions, inappropriate analyses and lack of accountability of losses were reasons for a N rating for four trials (Horne 1990; Kapoor 2000; Pring 1988; Roumen 1991). Blinding of outcome assessors (item 3) No trial reported blind outcome assessment although four trials ( Howard 1989; Kreder 2006; Pring 1988; Young 2003) referred to independent assessors for some outcomes. Total blinding of outcome assessment is impractical for trials testing surgical interventions but it is possible for some outcomes and more so at longerterm follow up. Comparability of baseline characteristics (item 4) Two trials (Hegeman 2004; Kreder 2006) provided sufcient information indicating the similarity in the baseline characteristics of gender, age and type of fracture. Potentially important imbalances between treatment groups in participant characteristics, where information was provided, were found in Jenkins 1989 (age), Lagerstrom 1999 (gender) and Zheng 2003 (gender). Blinding of patients and treatment providers (items 5 and 6) These are unlikely in these studies and none was claimed. Care programme comparability (item 7) We found it difcult to conrm comparability of care programmes other than the trial interventions, although we judged it highly likely in two trials (Howard 1989; Lagerstrom 1999). Systematic differences between the arms of a trial, such as the different methods of anaesthesia for closed reduction in Kreder 2006, can change the actual comparison under test. Description of inclusion criteria (item 8) Ten trials provided sufcient trial inclusion and exclusion criteria to dene their study populations. This item was rated N (not
met) in Pring 1988 where no details of the type of fractures included were available aside from Colles. Denition of outcome measures and quality of outcome measurement (items 9 and 10) The denition of outcome measurement was clear enough to give a good idea of what was recorded in all of the included trials except Stein 1990. Two trials (Horne 1990; Stein 1990) were considered to have inadequate outcome measurement, which included follow up of variable duration. Only Kreder 2006 was rated as having optimal quality outcome measurement, which included use of validated patient assessed quality of life instruments and active follow up. Nonetheless, several other trials (including Hegeman 2004; McQueen 1996; Young 2003) had active follow up and applied clearly relevant measures of function. Of note is the grading or scoring of overall functional outcome according to nonvalidated scoring systems in several trials. These systems, which often included anatomical and clinical outcomes, included modications of other scoring systems such as that of Gartland and Werley (Gartland 1951). Also, noted but not rated, were instances where adjustments were made for hand dominance. The variety of schemes used and other outcome measures reported by the trials is evident from inspection of the Characteristics of included studies table.
Length of follow up (item 11) Follow up ranged from a minimum of four months (Horne 1990) to 10 years (Howard 1989). Follow up of variable duration at times where participants are at different stages of recovery, may be a potential cause of bias in Horne 1990 (4 to 15 months) and Stein 1990 (6 months to 4 years). Loss to follow up (not rated) Loss to follow up was substantial in several trials (see Characteristics of included studies table and Table 5). Nearly a third of participants were missing from the nal analyses of Kapoor 2000 and Young 2003. The latter trial, however, gave a full account of the losses at seven years whereas losses were not explained in Kapoor 2000. For some of the trials appearing to have no losses, it may be the case that these were not reported.
Effects of interventions
In the following, the results are presented for the basic comparison, namely external xation versus plaster cast immobilisation, despite the evident variation among the trials in patient characteristics and interventions (see Table 4), and in the methods and timing of outcome assessment and selection of reported outcomes (see below and Characteristics of included studies table). Furthermore, few of the trials are sufciently similar to fall neatly into specic sub-categories. For instance, the pooling of data from the two trials studying treatment of redisplaced fractures in older
18
people (McQueen 1996; Roumen 1991) would appear valid but there remains clear dissimilarity in the known characteristics of the trials (e.g. different types of external xator; the re-reduction of fractures in the conservative treatment group and the inclusion of extra-articular fractures in McQueen 1996 but not in Roumen 1991). Hence, whilst some exploratory analysis has taken place, we considered that, on the whole, subgroup analysis was not appropriate. Separate data for participants in the three trials with optional supplementary pinning were not available. Functional outcome and impairment Final overall functional outcome, or some aspect of function, was considered better in the external xation group in eight studies ( Abbaszadegan 1990; Howard 1989; Jenkins 1989; Kapoor 2000; Pring 1988; Rodriguez-Merchan 92; Stein 1990; Zheng 2003). No statistically signicant differences in nal functional outcome were reported by seven studies (Horne 1990; Kreder 2006; Lagerstrom 1999; McQueen 1996; Pring 1988; Roumen 1991; Young 2003). Though some statistically signicant differences in some aspects of function were apparent at one year follow up in Young 2003, the trialists considered that the differences were not clinically signicant; nonetheless we have presented these as well as the seven year results in the analyses. Functional scores Functional scoring systems were used in 13 of the trials ( Abbaszadegan 1990; Hegeman 2004; Horne 1990; Howard 1989; Jenkins 1989; Kapoor 2000; Kreder 2006; Pring 1988; RodriguezMerchan 92; Roumen 1991; Stein 1990; Young 2003; Zheng 2003); most were modications of Gartland and Werleys scheme (Gartland 1951). Some consideration of deformity was present in the schemes used by Abbaszadegan 1990, Hegeman 2004, Kapoor 2000, Pring 1988 and Roumen 1991; whilst various complications were included in that used by six trials (Hegeman 2004; Horne 1990; Howard 1989; Kapoor 2000; Young 2003; RodriguezMerchan 92). The functional scores were usually graded into four categories (excellent, good, fair and poor). However, some trials reported results for combined categories (such as fair or poor) only. Jenkins 1989 and Stein 1990 presented results split by subjective and objective gradings. The subjective end gradings from Jenkins 1989 and Stein 1990 were pooled with the overall functional gradings from the other studies in Analyses 01.01, 01.02 and 0.03. A higher proportion of people treated with external xation achieved an excellent functional grading; in other words, a lower proportion of people treated with external xation had a not excellent grading (see Analysis 01.01: 134/256 versus 166/265; RR 0.82, 95% CI 0.71 to 0.95). Analysis 01.02 shows a worst-case (for conservative treatment) and then a best-case analysis for this outcome. The result strongly favours external xation when it is assumed that all participants lost to follow up or excluded (not possible for Horne 1990) in the external xation group had an excellent result compared with none of those lost or excluded from the conservative treatment group. In the converse case, a neutral result is obtained (RR 1.09, 95% CI 0.95 to 1.25). More people
in the external xator group achieved excellent grades at 10 years in Howard 1989 but the data presented in the two abstract reports for long-term follow up were inconsistent. As shown in Analysis 01.03, the numbers with an unsatisfactory outcome (either fair or poor gradings) were statistically signicantly fewer in the external xation group (62/308 versus 83/304; RR 0.73; 95% CI 0.55 to 0.98; xed-effect model). This was not statistically signicant when using the random-effects model (RR 0.72; 95% CI 0.47 to 1.09: analysis not shown). The signicant heterogeneity (P = 0.07; I = 41.4%) is lost on the removal of the results of Roumen 1991 and the result is again statistically signicant (RR 0.65, 95% CI 0.47 to 0.88; analysis not shown). In summary, these pooled results from non-validated functional scoring schemes favour external xation in terms of more people with excellent results (depicting a good recovery) and fewer people with an unsatisfactory outcome (either fair or poor result). However, as shown by the results of sensitivity analyses (e.g. Analysis 01.02) such ndings are not robust. Analysis 01.04 presents the separate subjective and objective results reported in Jenkins 1989 and Stein 1990: here it is notable that the trial participants of Jenkins 1989 rated the end functional result less favourably than the result using objective measures. Kreder 2006 found non-signicant trends to better functional results for the surgical group in the upper extremity function part of the Musculoskeletal Function Assessment tool (see Analysis 01.05), and in the results for the bodily pain domain of the SF-36 and JebsenTaylor (Jebsen 1969) hand function scores (data reported as standard deviations from the norm for these outcomes are not presented in the Analyses). The mean demerit Scheck score (Scheck 1962) for function was better, but not statistically signicantly so, in the external xation group of Pring 1988 at six months (3.30 versus 4.19). Activities of daily living At three months, more people in the external xation group of Hegeman 2004 had problems with some activities of daily living; this was signicant for ne hand co-ordination (see Analysis 01.06). None of the differences were signicant at one year for Hegeman 2004. Young 2003 found similar numbers of people in the two groups experiencing difculties with specic functional tasks at seven years (see Analysis 01.06). Occupation There was no signicant differences between the two groups of Kreder 2006 in the numbers of people who changed their job because of their injury at six months, one year or two years (see Analysis 01.07). The time to return to work or normal activities averaged 70 versus 75 days in Young 2003 (statistical signicance not reported). Grip strength The greater grip strength in the external xation groups of Jenkins 1989 and Young 2003 (1 year data) was statistically signicant (see Analysis 01.08). Kapoor 2000 found a marginally statistically signicantly better restoration of grip strength in the external xation
19
group (70% versus 63% of unaffected arm; reported P = 0.05). The differences between the two groups in mass grip strength were found not to be statistically signicant at nal follow up in seven trials: Abbaszadegan 1990, Hegeman 2004 (see Analysis 01.08), Kreder 2006 (see Analysis 01.09); Lagerstrom 1999 (see Analysis 01.10), McQueen 1996 (see Analysis 01.08), Pring 1988 (mass grip strength as % of normal side: 67.6% versus 63.8%) and Young 2003 (7 year results: see Analysis 01.08). Due to the statistically signicant heterogeneity (P = 0.004; I = 77.6%) in the results of the four trials (Hegeman 2004; Jenkins 1989; McQueen 1996; Young 2003) providing data for grip strength, these were not pooled. Lagerstrom 1999, who measured isometric grip strength, found that the recovery in grip strength was slower in the external xator group and considered there was some indication for specic physiotherapy for patients treated by external xation. One person in the external xator group in Young 2003 at seven years had persistent wrist weakness necessitating a wrist splint. Pain Pain was reported as being signicantly less in the external xator group in Abbaszadegan 1990 (nal mean visual analogue score (0 to 10 severe): 0 versus 1; reported P < 0.002) but numbers with persistent pain were reported to be similar in Hegeman 2004, Lagerstrom 1999 (19% overall had persistent pain after two years; separate data by intervention group were not available) and Young 2003 (see Analysis 01.11). Roumen 1991 reported the numbers of patients experiencing pain: at rest, during movement and ulnar compression pain. There were no statistically signicant differences for any of these three measures (see Analysis 01.12). Young 2003 also gave details of the circumstances for persistent pain at seven years; notably the constant pain on movement of the wrist in two people in the external xation group was sufcient for them to adapt their activities to avoid using the wrist. Range of movement The available data for range of movement are presented in Analyses 01.13 to 01.16. The difference in the exion/extension arc values were reported as being statistically signicant, in favour of the external xator group, in Abbaszadegan 1990 (% of normal wrist: 95% versus 83%; reported P = 0.0002), but not in McQueen 1996 (see Analysis 01.13). McQueen 1996 also found no difference in the overall range of motion. Only wrist extension was better in the external xation group at one year in Hegeman 2004. There were no statistically signicant differences in range of motion outcomes at one year for Jenkins 1989 (see Analysis 01.13). There was no indication in Kapoor 2000 as to whether the superior range of motion in the external xator group was reected in statistically signicant differences in the losses in the following three parameters: dorsi-palmar exion (19 versus 37 degrees); radial-ulnar deviation (13 versus 16 degrees); pronation-supination (23 versus 40 degrees). Kreder 2006 reported there was no statistically signicant differences in wrist and forearm range of motion at any of the follow ups, on the application of the Bonferroni correction
for multiple comparison testing. The clinical implications of the signicant ndings, when not using the Bonferroni correction, for Kreder 2006 at two years in favour of external xation in exion and radial deviation, and in favour of plaster cast for supination, are not known but are likely to be minor (see Analysis 01.14). Though statistically signicant, the differences between the two groups in ulnar deviation and pronation at one year follow up in Young 2003 are not clinically important (see Analysis 01.15); there were no statistically signicant differences in range of motion outcomes at seven year follow up of this trial (see Analysis 01.16). Clinical outcome and complications Complications The various complications suffered by the participants of these trials are presented in Analysis 01.17. Null events have also been entered when reported. Redisplacement resulting in secondary treatment mainly occurred in the conservative treatment groups, the exceptions being three participants whose external xator was distracted to combat radial shortening in Howard 1989, one participant given open reduction and internal xation in Kreder 2006 and three participants who underwent remanipulation in Young 2003. Similarly, redisplacement or, as in McQueen 1996, recurrent instability of already redisplaced fractures were signicantly more common in conservatively treated participants. Pin-site infections in 10 of the 69 people with pin-track infections (61/444 versus 1/402; RR 12.02, 95% CI 5.07 to 28.49) did not resolve with cleansing and antibiotics or, in Kreder 2006, with the early removal of supplementary percutaneous pins. Of the three serious infections in Jenkins 1989, two infections were recurrent and resulted in xator removal and one developed into the only reported case of osteomyelitis. Surgical curettage of the pin tracks was required for two people in Kreder 2006. Two infections resulted in xator removal in McQueen 1996, and the third required curettage. The two infections in Stein 1990 resolved on xator removal; it is not clear whether this was premature. Some reference to care of pin sites was made in six trials (Howard 1989; Jenkins 1989; Kapoor 2000; Kreder 2006; McQueen 1996; RodriguezMerchan 92). There are 10 other cases of pin loosening or other pin site problems (see Analysis 01.17). In addition, Pring 1988 reported several complications for external xation including thumb pain and various pin-related problems (see Characteristics of included studies table) but failed to distinguish between primary and secondary external xation. Radial nerve neuropathy, often a short term sensory disturbance of the supercial radial nerve, was more common in the external xator group; radial nerve symptoms in the plaster cast group were reported in a few cases of Howard 1989 and Young 2003. There was a marked excess of nerve related complications in the conservative treatment group in Howard 1989 that was not so apparent in the other trials. The majority of cases of reex sympathetic dystrophy (RSD) were reported as serious, requiring many months of intensive physiotherapy to resolve. There is no statistically signicant difference
20
between the two groups (25/384 versus 17/347; RR 1.31, 95% CI 0.74 to 2.32) in RSD. Previously, in Handoll 2003a, it was noticed that the two trials (McQueen 1996; Roumen 1991) including redisplaced, and hence unstable, fractures as well as older participants had more cases of RSD in the external xator group, in contrast to most of the other included trials. As before, an exploratory analysis (see Analysis 01.18) was set to examine the difference in the direction of effect of the two subgroups (primary displaced fractures versus redisplaced fractures). As the difference between the two results is not statistically signicant (P = 0.191) more evidence is required to establish if external xation has a greater risk of RSD in older people with proven unstable fractures. It should also be noted that the differences between the two treatment groups in either subgroup of trials did not reach statistical signicance. Most cases with arthritis at seven years had mild cases of joint space narrowing in Young 2003 (11 versus 12); only one was symptomatic. The severity of the arthritic changes at 10 years in Howard 1989 was not reported (see Analysis 01.17). Cosmetic outcomes There were no signicant differences between the two groups in overall cosmetic deformity (Kapoor 2000) or various features of cosmetic deformity described in Hegeman 2004 (see Analysis 01.19). Howard 1989 reported that the pin-track scars were accepted by the patients; the only complaint being that the xator made it difcult to use the hand. In Young 2003, 13 of the 36 people available at seven year follow up had unsightly forearm scars at the proximal pin insertion sites. Young 2003 found there was no difference between the two groups in the few people who were dissatised with their wrist at seven years (see Analysis 01.20). Anatomical outcome (anatomical restoration and residual deformity) Overall anatomical results at nal radiological follow up were better, often signicantly so, in the external xation group in all trials except Horne 1990. The results of Horne 1990 may in part reect the choice of radiological parameters (Van der Linden 1981) reported in Horne 1990 and the small numbers of participants ( Axelrod 1991). Differences between the one year and seven year results for radial shortening (see Analysis 01.23) and dorsal angulation (see Analysis 01.24) in Young 2003 probably reveal a trend for deterioration over time but other factors, including the reduction in the sample size at seven years, may also inuence these results. All the other trials indicated that external xation held the reduced position better than plaster cast immobilisation. Redisplacement requiring secondary treatment occurred in 15% of conservatively treated fractures over nine trials (see Analysis 01.17: 7/356 versus 51/338; RR 0.17, 95% CI 0.09 to 0.32). Exceptionally, there were similar numbers of people in the two groups with redisplacement and treated redisplacement in Young 2003. Secondary treatment for redisplaced conservatively treated fractures consisted of remanipulation and external xation in Abbaszadegan 1990, Lagerstrom 1999 and Pring 1988; these participants were
then analysed as a separate group in these three trials. External xation group participants with serious infection and plaster cast group participants requiring remanipulation were excluded from the rest of the analyses in Jenkins 1989. It is of concern to note that four people were recorded as requiring remanipulation in the full report of this trial, but six in another report (Jenkins 1988). Howard 1989 (external xator group: distraction of the xator increased for loss in radial length; plaster cast group: remanipulation), Kreder 2006 (external xator group: open reduction and internal xation; plaster cast group: external xation if remanipulation was unsuccessful), Stein 1990 (plaster cast group: remanipulation) and Young 2003 (both groups: remanipulation) all retained those participants conrmed as having secondary treatment for redisplacement. Most of the 27 redisplacements occurring in the conservative treatment group in Rodriguez-Merchan 92 were probably remanipulated, but this was not stated explicitly in the trial report. Kreder 2006 reported that similar numbers had distal radius ulnar joint instability at six weeks (3/54 versus 2/59; RR 1.64, 95% CI 0.28 to 9.44); one person in the external xation group had stabilisation of this joint by ulnar styloid repair. Statistically signicantly fewer people in the external xator group had recurrent instability in McQueen 1996 (14/60 versus 16/30; RR 0.44, 95% CI 0.25 to 0.77). Anatomical scores Four of the six trials rating overall anatomical results used the same rating scheme (Stewart 1984; Stewart 1985) which was derived from the scheme used by the two other trials (Roumen 1991; Stein 1990). The pooled results from these six trials give a consistent picture of the signicantly superior anatomical results for external xation (see Analysis 01.21 Anatomical grading: not excellent. 90/202 versus 148/169; RR 0.53, 95% CI 0.45 to 0.61; and Analysis 01.22 Anatomical grading: fair or poor. 17/214 versus 96/186; RR 0.17, 95% CI 0.11 to 0.27). It should be noted that the removal of the highly favourable results for the external xation group of Stein 1990 shows these to be the basis of the statistically signicant heterogeneity (P = 0.02; I = 67%) in Analysis 01.21. This may be associated with the signicantly better postreduction results in the external xation group of this trial, despite closed reduction being used in both groups. Radiological parameters The differences, in favour of the external xation group, between the two treatment groups in the mean values of individual radiological parameters were reported to be statistically signicant, often without conrmatory data, in eight trials: Abbaszadegan 1990 (dorsal angulation; radial shortening); Hegeman 2004 (dorsal angulation, radial angulation); Howard 1989 (dorsal angulation; radial shortening); Jenkins 1989 (dorsal angulation; loss in radial angulation; radial shortening), McQueen 1996 (dorsal angulation), Pring 1988 (radial angulation; from graph), Young 2003 (dorsal angulation (at one year); radial shortening); Zheng 2003 (dorsal angulation; ulnar angulation; radial shortening. Rodriguez21
Merchan 92 also reported superior results in the external xator group; for example, dorsal angulation (mean: 0.2 versus 9.5 degrees) and loss of radial length (mean: 0.5 mm versus 4.1 mm). Losses in various radiological parameters in those trials providing sufcient data are presented in Analysis 01.23. This shows that all losses in these parameters were less in the external xation group, with two exceptions (Horne 1990: dorsal displacement; McQueen 1996: radial shortening). Since statistically signicant heterogeneity (I = 94.9%) was evident for radial shortening, pooling was not performed. The data presented in the analyses for Jenkins 1989 pertain to the time of fracture union and removal of cast and xator at around four weeks. Later data at one year for this trial showed a further loss in mean radial length in the external xator group compared with a slight gain in the cast group (mean loss: 1.24 mm versus -0.70 mm). Radial length shortening had worsened in both groups of Young 2003 at seven year follow up and the difference between the two groups was no longer statistically signicant (see Analysis 01.23); however, the difference was reported to be statistically signicant in both the draft and published reports (P < 0.05). Kreder 2006 reported the trend for better restoration in radial length and palmar tilt (volar angulation) in the external xation group was not statistically signicant. Superior anatomical values for dorsal and radial angulation and radial length were usually evident and claimed for the external xation group (see Analysis 01.24) but the variation in the denitions of dorsal angulation and normal values makes the results hard to interpret. Residual deformity Several other measures of structural deformity are presented in Analysis 01.25. Trialist-dened malunion (based on dorsal angulation and radial shortening) reported by McQueen 1996 and Young 2003 was signicantly less in the external xation group at one year (36/108 versus 47/90; RR 0.58, 95% CI 0.41 to 0.81). In contrast, the incidence of malunion in those patients available at seven years follow up in Young 2003 was similar in the two groups (RR 0.96; 95% CI 0.63 to 1.47). Jenkins 1989 found a better reduction and xation of die-punch fractures in the external xation group; this may reect the particular design of non-bridging xator used in this trial where the distal pins also transxed the fracture fragments. Resource use No trial provided quantitative data on resource use and costs. It is not known how many people receiving surgery were day cases, thus avoiding the costs of a hospital bed. Overnight hospital admission was routine for surgical patients in Rodriguez-Merchan 92 whereas Horne 1990 referred to a day-care facility. Stein 1990 referred to admission to hospital for 24 hours or to a day-care facility. There was no report of the cost implications of remanipulation of redisplaced fractures or of the routine care of pin sites or additional care resulting from pin site infection.
DISCUSSION
This review of a common surgical intervention for one of the most common fractures has 15 included trials involving a total of only 1022 participants. Though essentially these trials evaluated one basic comparison, namely external xation versus plaster cast immobilisation, there was considerable variation in the trials especially in terms of patient characteristics and interventions (see Table 4); and in their methods, including outcome assessment. Limitations of the review methods As this review abided by the criteria and methods set out in a published protocol, we have restricted our comments to two issues. The rst is the question of whether trials have been missed or inappropriately excluded in our search and selection processes. The second issue concerns decisions made regarding pooling and subgroup analysis. Our search was comprehensive and built on searches carried out over many years prior to the separate development of this review (Handoll 2003a). It has included the handsearch of conference proceedings and checks for ongoing trials. An inclusive and benet-of-doubt approach during trial searches has been maintained throughout by the lead author (HH). Additionally, trial authors of unpublished trials have been sent requests for information and trial reports. It is possible that we have missed some potentially eligible trials but, if so, these may still not be suitable for inclusion, particularly if unpublished and inadequately reported. We guarded against study selection bias by the independent selection of eligible trials by all three review authors. We decided to pool the results of evidently heterogeneous trials in an attempt to address the basic question of whether external xation of any kind produces signicantly different results compared with conservative treatment (plaster cast) in adults with distal radial fractures. We considered grouping trials by participant age and gender according to the three categories described in Description of studies; in particular to examine the results in good quality bone in the younger age group compared with osteoporotic bone in the older age group. However, we decided that any ndings would be impossible to interpret given the other differences in characteristics (types of fracture and interventions, assessment of outcome, methodology) and quality of the studies in the different age groups. Thus we concluded that the subgrouping the 15 trials into smaller separate categories was not viable. We, however, made one exception by subgrouping according to primary and secondary displaced fractures for RSD (see Analysis 01.18). This reected a previously set up hypothesis in Handoll 2003a. As discussed below, our overall approach has important implications in terms of the interpretation of review ndings. Limitations of the review evidence Overall, the available evidence is limited in scope and quantity, and is of uncertain validity. The usual reservations of the reliability
22
of evidence from small and underpowered trials apply. Especially, we were careful to avoid mis-interpreting inconclusive evidence as evidence of no effect. Systematic bias, in the form of selection, performance, exclusion or assessment bias, or a combination of these could not be ruled out for any trial. However, this was much less a concern with Kreder 2006, which was the only trial with clearly concealed treatment allocation. Another limitation was the inadequate assessment of outcome, particularly of function and in the long term. Non-validated outcome measures, such as those based on the Gartland and Werley scoring system (Gartland 1951), that combine aspects of function, pain, deformity and complications are particularly crude indicators of outcome. Considerable caution is needed when interpreting these, especially when the scores have been reduced into categories such as excellent, good, fair or poor. Many trials predated the development of validated patient functional assessment instruments such as Short Form-36 (SF-36), the Disability of the Arm, Shoulder, and Hand questionnaire (DASH) and the Patient-Rated Wrist Evaluation (PRWE) (MacDermid 2000). These help to standardise functional assessment in a meaningful way and assist interpretation (Amadio 2001). Again, Kreder 2006 proved an exception. Applicability of the review evidence Generalising the ndings of the included trials, should these be valid, is hampered by inadequate reporting of study details: in particular, the type and severity of the fracture, and quality of bone, all of which are key determinants of treatment and prognosis. The variety of fracture classication systems, with associated issues of reliability and validity further complicates this area (Jupiter 1997) and hinders direct comparisons between trials. For example, the
two fracture classications used by trials in this review (the AO and Frykman) place different emphases on various fracture patterns and anatomical components. Studies have revealed unsatisfactory interobserver reliability and intraobserver reproducibility for both classication systems (Andersen 1996; Kreder 1996b). Moreover, a large retrospective study found that neither classication system was useful for predicting clinical outcome (Flinkkila 1998). Thus, both fracture classication systems have been shown to have serious limitations. Nine trials in this review stipulated criteria for anatomical displacement of the fracture for trial entry. However, Kreder 1996a found quite broad margins of error (tolerance limits) for anatomical measurements in general. This with other factors, such as variations in anatomical reference points, again hinders treatment comparison. Fracture instability was the inherent or explicit criterion for many of the included trials, and proven for the two trials of redisplaced fractures (McQueen 1996; Roumen 1991). Generally though it is not established how best to predict fracture instability. A study of 4024 patients concluded that the patient age, metaphyseal comminution of the fracture and ulnar variance were the most important factors in predicting instability of distal radial fractures ( MacKenney 2006). Summary of the evidence We have summarized the evidence using the categories described in BMJ 2006 (see Table 3). The effectiveness of external xation compared with conservative treatment is graded as 3 (Trade off between benets and harms) as dened in Table 3. Some supporting information is provided in Table 6 and below.
Table 6. Category of effectiveness for external xation versus conservative treatment Comparison Category Justication Qualiers (1) Indications ( especially fracture types) for treatment; and type, technique and timing of EF not resolved. (2) Incomplete functional and long term outcome. (3) Heterogeneous interventions, patient characteristics. (4) Compromised methods of several trials means that serious bias cannot be ruled out. Comments Minimal details were usually provided for the conservative treatment intervention which always involved plaster cast immobilisation. There remains a possibility of suboptimal application of plaster casts in some trials. Some EF techniques were not optimal - increased risk of iatro-
External xation (EF) 3: Trade off between EF reduces redisversus conservative treat- benets and harms placement requiring secment ondary treatment (usually remanipulation under anaesthesia in the plaster cast group) and yields better anatomical results. However, the evidence of a better functional outcome from EF is weak. Moreover, EF is associated with a high risk of complications. Pin site infection, while common, is generally re-
23
Table 6. Category of effectiveness for external xation versus conservative treatment
(Continued)
solvable with local treatment. Other complications, such as supercial radial nerve paraesthesia, are less common but often more serious. Superior anatomical results, both in maintaining the reduced fracture position and in nal anatomy, in the external xation group were evident in all trials except Horne 1990 and Young 2003. Putative reasons for these two exceptions are given in the Results. The functional results of the included trials presented a mixed and incomplete picture, albeit potentially favouring external xation, that is to a great extent based on functional grades from non validated scoring systems that also rate radiological deformity. As explained above, there are insufcient data to explore the effects of different trial characteristics, including age, on functional results. Secondary displacement, here often termed redisplacement, after primary reduction and recurrent instability after re-reduction in redisplaced fractures was a frequent complication of conservatively treated patients. Most of the redisplacements resulted in a second reduction and application of a second plaster cast. Although some redisplacements might be explained by operator error, this nding is a reasonable indication of the instability of fractures in the trial populations. However, though external xation was more effective in holding a reduced fracture position it comes at a price of a high number of associated complications. Most of the complications related to external xator pins were pin-track infections that resolved with cleansing and antibiotics and there was a low incidence of pin loosening and premature removal of the external xator. Radial nerve injury was more common in the external xation group and can be a consequence of poor pin placement resulting from suboptimal surgical technique (Ahlborg 1999; Seitz 1993); the use of stab incisions in Horne 1990 rather than small incisions to visualise and retract soft-tissue during pin insertion was criticised (Axelrod 1991). RSD occurred in nearly six per cent of patients (42/731); we could not conrm that RSD was more common in patients with redisplaced fractures that had been treated by external xation. Data for long-term complications and overall outcome were too limited for comments, aside from their general absence. Sufcient data were not available to undertake meaningful subgroup analysis; e.g. fracture pattern, patient characteristics, variations in the interventions. The considerable variation in the trials
genic complications.
means that only the basic question of whether external xation confers some benet is addressed here. Some clues as to the best methods of external xation may arise from the pending systematic review of the evidence from direct comparisons of different methods of external xation (Handoll 2007).
AUTHORS CONCLUSIONS Implications for practice

There is some evidence from a set of 15 heterogeneous and generally methodologically weak trials to support the use of external xation for dorsally displaced fractures of the distal radius in adults. While the evidence shows that external xation maintains reduced fracture positions and prevents late collapse and malunion compared with plaster cast immobilisation, there was insufcient evidence to conrm a superior overall functional or clinical result. External xation was associated with a high number of complications but many of these were minor and some would probably have been avoided using a different surgical technique for pin insertion. There was not enough evidence to prove or disprove a difference in more serious complications between the two groups.
Implications for research

Given that a distal radius fracture in adults is a common injury and given that there is limited knowledge about the best method of treatment, either conservative or surgical, further research is called for (Handoll 2003a). However, rather than embark on yet more small single-centre trials, particularly those with inadequate methodology that are unlikely to provide the good quality generalisable evidence required, the identication of the priority questions for the management of these fractures is required (Handoll 2003c). The updating of the evidence summaries of other surgical interventions for these fractures is likely to inform this process.
ACKNOWLEDGEMENTS
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We thank Lesley Gillespie for her help with the search strategy. We thank the following for helpful comments and input at the editorial and external review of the protocol: Joanne Elliott, Bill Gillespie, Jesse Jupiter, Lindsey Shaw and Janet Wale. We thank the following for helpful comments at the editorial and external review of the review: Lesley Gillespie, Jesse Jupiter, Vicki Livingstone and Janet Wale. We thank Joanne Elliott and Lindsey Shaw for their help during editorial processing of the review. We thank Xiaoyan Chen for a translation from Chinese. We thank Jean Goodman, at the British Orthopaedic Association, for facilitating the perusal of the Jenkins trial thesis. We are also very grateful to those trialists, in particular Claire Young for extensive feedback, who provided clarication and further information on their trials.
REFERENCES
References to studies included in this review

Abbaszadegan 1990 {published data only} Abbaszadegan H, Jonsson U. External xation or plaster cast for severely displaced Colles fractures? Prospective 1-year study of 46 patients. Acta Orthopaedica Scandinavica 1990;61(6):52830. Hegeman 2004 {published data only} Hegeman JH. personal communication October 10 2006. Hegeman JH, Oskam J, Van der Palen J, ten Dius HJ, Vierhout PAM. Primary external xation versus plaster immobilization of the intra-articular unstable distal radial fracture in the elderly. Aktuelle Traumatologie 2004;34(2):6470. Horne 1990 {published data only} Axelrod TS. A prospective randomized trial of external xation and plaster cast immobilization in the treatment of distal radius fractures. Journal of Orthopaedic Trauma 1991;5:1145. Devane P, Horne JG. A prospective trial comparing external xation with closed reduction and cast immobilisation in the treatment of distal radial fractures [Abstract]. Journal of Bone and Joint Surgery - British Volume 1988;70(3):507. Horne G. A prospective randomized trial of external xation and plaster cast immobilization in the treatment of distal radius fractures [letter; comment]. Journal of Orthopaedic Trauma 1991;5(2):246. Horne G, Devane P. A prospective randomised trial of external xation and plaster cast immobilisation in the treatment of distal radial fractures [Abstract]. Orthopaedic Transactions 1989;13(3): 531. Horne JG, Devane P, Purdie G. A prospective randomized trial of external xation and plaster cast immobilization in the treatment of distal radial fractures [see comments]. Journal of Orthopaedic Trauma 1990;4(1):304. Howard 1989 {published data only} Freeman BJC, Atherton WG, Howard PW, Burke FD. External xation or manipulation and plaster for severely displaced
comminuted Colles fractures? [Abstract]. Journal of Bone and Joint Surgery - British Volume 1998;80 Suppl 1:53. Freeman BJC, Atherton WG, Howard PW, Burke FD. External xation or manipulation and plaster for severely displaced comminuted Colles fractures? [Abstract]. Journal of Bone and Joint Surgery - British Volume 2000;82 Suppl 2:171. Howard PW, Stewart HD, Hind RE, Burke FD. External xation or plaster for severely displaced comminuted Colles fractures? A prospective study of anatomical and functional results. Journal of Bone and Joint Surgery - British Volume 1989;71(1):6873. Jenkins 1989 {published and unpublished data} Jenkins NH. The treatment of Colles fracture [Masters thesis: Winner of Robert Jones Gold Medal and Association Prize 1989]. London: British Orthopaedic Association, 1988. Jenkins NH, Jones DG, Johnson SR, Mintowt-Czyz WJ. External xation of Colles fractures. An anatomical study. Journal of Bone and Joint Surgery - British Volume 1987;69(2):20711. Jenkins NH, Jones DG, Mintowt-Czyz WJ. External xation and recovery of function following fractures of the distal radius in young adults. Injury 1988;19(4):2358. Jenkins NH, Jones DG, Mintowt-Czyz WJ. The role of external xation in treating the Colles fracture [Abstract]. Journal of Bone and Joint Surgery - British Volume 1989;71(2):340. Kapoor 2000 {published data only} Kapoor H, Agarwal A, Dhaon BK. Displaced intra-articular fractures of distal radius: a comparative evaluation of results following closed reduction, external xation and open reduction with internal xation. Injury 2000;31(2):759. Kreder 2006 {published and unpublished data} Agel J. personal communication October 10 2006. Cebesoy O, Isik M. Is external xation necessary for distal radius fracture without joint incongruity? [letter]. Journal of Orthopaedic Trauma 2006;20(5):374. Kreder HJ, Agel J, McKee MD, Schemitsch EH, Stephen D, Hanel DP. A randomized, controlled trial of distal radius fractures with metaphyseal displacement but without joint incongruity:
25
closed reduction and casting versus closed reduction, spanning external xation, and optional percutaneous K-wires. Journal of Orthopaedic Trauma 2006;20(2):11521. Kreder HJ, Hanel DP, Agel J, McKee MD. A randomized controlled trial of closed reduction and casting versus closed reduction and external xation for distal radius fractures with metaphyseal displacement but without joint incongruity [Abstract]. American Society for Surgery of the Hand 57th Annual Meeting; 2002 Oct 3-5; Phoenix, AZ. 2002. Kreder HJ, Hanel DP, Agel J, McKee MD, Trumble TE. A randomized controlled trial of closed reduction and casting versus closed reduction and external xation for distal radius fractures with metaphyseal displacement but without joint incongruity [Abstract]. Orthopaedic Trauma Association Annual Meeting; 2002 Oct 11-13; Toronto, Ontario. 2002:http://www.hwbf.org/ ota/am/ota02/otapa/OTA02065.htm (accessed 01/11/02). Lagerstrom 1999 {published data only} Lagerstrom C, Nordgren B, Olerud C. Evaluation of grip strength measurements after Colles fracture: a methodological study. Scandinavian Journal of Rehabilitation Medicine 1999;31(1):4954. Lagerstrom C, Nordgren B, Rahme H. Recovery of isometric grip strength after Colles fracture: a prospective two-year study. Scandinavian Journal of Rehabilitation Medicine 1999;31(1):5562. McQueen 1996 {published data only} McQueen MM, Court-Brown CM. Unstable fractures of the distal radius: a prospective randomized comparison of four treatment methods [Abstract]. Orthopaedic Transactions 1997;21(2):5956. McQueen MM, Hajducka C, Court-Brown CM. Redisplaced unstable fractures of the distal radius. A prospective randomised comparison of four methods of treatment. Journal of Bone and Joint Surgery - British Volume 1996;78(3):4049. Pring 1988 {published data only} Pring DJ, Barber L, Williams DJ. Bipolar xation of fractures of the distal end of the radius: a comparative study. Injury 1988;19 (3):1458. Pring DJ, Williams DJ. Bipolar xation of fractures of the distal radius: a comparative study [Abstract]. Journal of Bone and Joint Surgery - British Volume 1986;68(4):666. Rodriguez-Merchan 92 {published data only} Merchan EC, Breton AF, Galindo E, Peinado JF, Beltran J. Plaster cast versus Clyburn external xation for fractures of the distal radius in patients under 45 years of age. Orthopaedic Review 1992;21(10): 12039. Roumen 1991 {published data only} Roumen RM, Hesp WL, Bruggink ED. Unstable Colles fractures in elderly patients. A randomised trial of external xation for redisplacement. Journal of Bone and Joint Surgery - British Volume 1991;73(2):30711. Stein 1990 {published data only} Stein H, Volpin G, Horesh Z, Hoerer D. Cast or external xation for fracture of the distal radius. A prospective study of 126 cases. Acta Orthopaedica Scandinavica 1990;61(5):4536. Young 2003 {published and unpublished data} Nanu AM, Pappasaras S, Rangan A, Checketts RG. Plaster cast vs the Pennig dynamic xator for Colles fracture - a prospective
randomised trial [Abstract]. Journal of Bone and Joint Surgery British Volume 1994;76 Suppl 2 & 3:149. Young CF. personal communication April 21 2002. Young CF. personal communication August 18 2002. Young CF, Nanu AM, Checketts RG. Plaster immobilisation versus Pennig external xator for distal radius fractures [Abstract]. Journal of Bone and Joint Surgery - British Volume 2000;82 Suppl 1:83. Young CF, Nanu AM, Checketts RG. Plaster immobilisation versus Pennig external xator for distal radius fractures [Abstract]. Presentation at the The Third Orthox Riva Congress; 2000 May 10-14; Riva del Garda, Italy 2000. Young CF, Nanu AM, Checketts RG. Seven-year outcome following Colles type distal radial fracture. A comparison of two treatment methods. Journal of Hand Surgery - British Volume 2003; 28(5):4226. Young CF, Nanu AM, Checketts RG. Seven year outcome study of Colles type distal radial fractures [Abstract]. Journal of Bone and Joint Surgery - British Volume 2003;85(Suppl 1):27. Young CF, Nanu AM, Checketts RG. Seven year outcome study of Colles type distal radial fractures [Abstract]. Presentation at the The Third Orthox Riva Congress; 2000 May 10-14; Riva del Garda, Italy 2000. Zheng 2003 {published data only} Zheng HL, Wu F, Guo T, Cai J, Zhang Y. [A comparison of conservative and surgical treatment of distal radius unstable fracture]. Journal of Clinical Orthopaedics 2003;6(3):2113.
References to studies excluded from this review

Christensen 2001 {published data only} Christensen OM, Christiansen TC, Krasheninnikoff M, Lind B, Holmich LR, Hansen FF, et al.Plaster cast compared with bridging external xation for distal radius fractures of the Colles type. International Orthopaedics 2001;24(6):35860. Kongsholm 1989 {published data only} Kongsholm J, Olerud C. Plaster cast versus external xation for unstable intraarticular Colles fractures. Clinical Orthopaedics and Related Research 1989;(241):5765. Olerud C, Kongsholm J. External xation of comminuted Colles fractures gives better results than conservative treatment. Zeitschrift fur Unfallchirurgie, Versicherungsmedizin und Berufskrankheiten 1989;82(2):99105. Solgaard 1989 {published data only} Solgaard S, Bunger C, Solund K. Displaced distal radius fractures. A comparative study of early results following external xation, functional bracing in supination, or dorsal plaster immobilization. Archives of Orthopaedic and Trauma Surgery 1989;109(1):348. Sprenger 1988 {published and unpublished data} Sennwald G. personal communication August 1 2002. Sprenger FB, Sennwald G, Weber BG. Therapy of the Colles fracture with external xative [Abstract] [Die therapie der Collesfraktur mit xateur externe]. Hefte zur Unfallheilkunde 1988;200:300. van Dijk 1996 {published data only} Van Dijk JP, Laudy FG. Dynamic external xation versus nonoperative treatment of severe distal radial fractures. Injury 1996;27 (1):5761.
26
References to studies awaiting assessment

Moroni 2004 {published data only} Moroni A, Vannini F, Faldini C, Pegref F, Giannini S. Cast vs external xation: a comparative study in elderly osteoporotic distal radial fracture patients. Scandinavian Journal of Surgery 2004;93 (1):647.
Chitnavis 1999 Chitnavis J. The wrist. In: Pynsent PB, Fairbank JC, Carr AJ editor (s). Classication of musculoskeletal trauma. Oxford: Butterworth Heinemann, 1999:14670. Cooney 1980 Cooney WP 3rd, Dobyns JH, Linscheid RL. Complications of Colles fractures. Journal of Bone and Joint Surgery - American Volume 1980;62(4):6139. Cooney 1993 Cooney WP. Fractures of the distal radius. A modern treatmentbased classication. Orthopedic Clinics of North America 1993;24 (2):2116. Cummings 1985 Cummings SR, Kelsey JL, Nevitt MC, ODowd KJ. Epidemiology of osteoporosis and osteoporotic fractures. Epidemiologic Reviews 1985;7:178208. Fernandez 1996 Fernandez DL, Jupiter JB. Fractures of the distal radius. A practical approach to management. 1st Edition. New York: Springer-Verlag, 1996. Fernandez 1999 Fernandez DL, Palmer AK. Fractures of the distal radius. In: Green DP, Hotchkiss RN, Pederson WC editor(s). Greens Operative Hand Surgery. 4th Edition. New York: Churchill Livingstone, 1999: 92985. Flinkkila 1998 Flinkkila T, Raatikainen T, Hamalainen M. AO and Frykmans classications of Colles fracture. No prognostic value in 652 patients evaluated after 5 years. Acta Orthopaedica Scandinavica 1998;69(1):7781. Frykman 1967 Frykman G. Fracture of the distal radius including sequelae-shoulder-hand-nger syndrome, disturbance in the distal radioulnar joint and impairment of nerve function. A clinical and experimental study. Acta Orthopaedica Scandinavica Supplementum 1967;108:3153. Gartland 1951 Gartland JJ, Werley CW. Evaluation of healed Colles fractures. Journal of Bone and Joint Surgery - American Volume 1951;33(4): 895910. Handoll 2003a Handoll HH, Madhok R. Surgical interventions for treating distal radial fractures in adults (Cochrane review). Cochrane Database of Systematic Reviews 2003, Issue 3. Handoll 2003b Handoll HH, Madhok R. Conservative interventions for treating distal radial fractures in adults (Cochrane Review). Cochrane Database of Systematic Reviews 2003, Issue 2.[Art. No.: CD000314. DOI: 10.1002/14651858.CD000314] Handoll 2003c Handoll HHG, Madhok R. From evidence to best practice in the management of fractures of the distal radius in adults: working towards a research agenda. BMC Musculoskeletal Disorders 2003;4 (27).
27
Additional references
Ahlborg 1999 Ahlborg HG, Josefsson PO. Pin-tract complications in external xation of fractures of the distal radius. Acta Orthopaedica Scandinavica 1999;70(2):1168. Altissimi 1986 Altissimi M, Antenucci R, Fiacca C, Mancini GB. Long-term results of conservative treatment of fractures of the distal radius. Clinical Orthopaedics and Related Research 1986;(206):20210. Altman 2003 Altman DG, Bland JM. Interaction revisited: the difference between two estimates. BMJ 2003;326(7382):219. Amadio 2001 Amadio PC. Outcome assessment in hand surgery and hand therapy: an update. Journal of Hand Therapy 2001;14(2):637. Andersen 1996 Andersen DJ, Blair WF, Steyers CM Jr, Adams BD, el Khouri GY, Brandser EA. Classication of distal radius fractures: an analysis of interobserver reliability and intraobserver reproducibility. Journal of Hand Surgery - American Volume 1996;21(4):57482. Atkins 1989 Atkins RM, Duckworth T, Kanis JA. Algodystrophy following Colles fracture. Journal of Hand Surgery - British Volume 1989;14 (2):1614. Atkins 2003 Atkins RM. Aspects of current management: Complex regional pain syndrome. Journal of Bone & Joint Surgery - British Volume 2003;85(8):11006. Axelrod 1991 Axelrod TS. A prospective randomized trial of external xation and plaster cast immobilization in the treatment of distal radius fractures [letter; comment] [see comments]. Journal of Orthopaedic Trauma 1991;5(1):1145. Belsole 1993 Belsole RJ, Hess AV. Concomitant skeletal and soft tissue injuries. Orthopedic Clinics of North America 1993;24(2):32731. BMJ 2006 A guide to the text. Clinical Evidence Online http:// www.clinicalevidence.com/ceweb/about/guide.jsp (accessed 24 March 2006). Capo 2006 Capo JT, Swan KG Jr, Tan V. External xation techniques for distal radius fractures. Clinical Orthopaedics and Related Research 2006; 445:3041.
Handoll 2007 Handoll HHG, Madhok R, Huntley JS. Different methods of external xation for treating distal radial fractures in adults. Cochrane Database of Systematic Reviews 2007, Issue 2.[Art. No.: CD006522. DOI: 10.1002/14651858.CD006522.pub2] Higgins 2003 Higgins JP, Thompson SG, Deeks JJ, Altman DG. Measuring inconsistency in meta-analyses. BMJ 2003;327(7414):55760. Higgins 2005 Higgins JPT, Green S, editors. Highly sensitive search strategies for identifying reports of randomized controlled trials in MEDLINE. Cochrane Handbook for Systematic Reviews of Interventions 4.2.5 [updated May 2005]; Appendix 5b. In: The Cochrane Library, Issue 3, 2005. Chichester, UK: John Wiley & Sons, Ltd. Jebsen 1969 Jebsen RH, Taylor N, Trieschmann RB, Trotter MJ, Howard LA. An objective and standardized test of hand function. Archives of Physical Medicine & Rehabilitation 1969;50(6):3119. Jenkins 1988 Jenkins NH, Jones DG, Mintowt-Czyz WJ. External xation and recovery of function following fractures of the distal radius in young adults. Injury 1988;19(4):2358. Jupiter 1997 Jupiter JB, Fernandez DL. Comparative classication for fractures of the distal end of the radius. Journal of Hand Surgery - American Volume 1997;22(4):56371. Knirk 1986 Knirk JL, Jupiter JB. Intra-articular fractures of the distal end of the radius in young adults. Journal of Bone and Joint Surgery - American Volume 1986;68(5):64759. Kreder 1996a Kreder HJ, Hanel DP, McKee M, Jupiter J, McGillivary G, Swiontkowski MF. X-ray lm measurements for healed distal radius fractures [published erratum appears in J Hand Surg [Am] 1996 May;21(3):532]. Journal of Hand Surgery - American Volume 1996; 21(1):319. Kreder 1996b Kreder HJ, Hanel DP, McKee M, Jupiter J, McGillivary G, Swiontkowski MF. Consistency of AO fracture classication for the distal radius. Journal of Bone & Joint Surgery - British Volume 1996; 78(5):72631. Kreder 2005 Kreder HJ, Hanel DP, Agel J, McKee M, Schemitsch EH, Trumble T, et al.Indirect reduction and percutaneous xation versus open reduction and internal xation for displaced intra-articular fractures of the distal radius: A randomised controlled trial. Journal of Bone & Joint Surgery - British Volume 2005;87(6):82936. MacDermid 2000 MacDermid JC, Richards RS, Donner A, Bellamy N, Roth JH. Responsiveness of the short form-36, disability of the arm, shoulder, and hand questionnaire, patient-rated wrist evaluation, and physical impairment measurements in evaluating recovery after a distal radius fracture. Journal of Hand Surgery - American Volume 2000;25(2):33040.
MacKenney 2006 MacKenney PJ, McQueen MM, Elton R. Prediction of instability in distal radial fractures. Journal of Bone and Joint Surgery American Volume 2006;88(9):194451. Muller 1991 Muller M, Allgower M, Schneider R, Willenegger H. Manual of internal xation: techniques recommended by the AO-ASIF Group. 3rd Edition. Berlin: Springer-Verlag, 1991. ONeill 2001 ONeill TW, Cooper C, Finn JD, Lunt M, Purdie D, Reid DM, et al.Incidence of distal forearm fracture in British men and women. Osteoporosis International 2001;12(7):5558. Older 1965 Older TM, Stabler EV, Cassebaum WH. Colles fracture: Evaluation and selection of therapy. Journal of Trauma 1965;5(4):46976. Pennig 1996 Pennig D, Gausepohl T. External xation of the wrist. Injury 1996; 27(1):115. Sahlin 1990 Sahlin Y. Occurrence of fractures in a dened population: a 1-year study. Injury 1990;21(3):15860. Scheck 1962 Scheck M. Long-term follow-up of treatment of comminuted fractures of the distal end of the radius by transxation with Kirschner wires and cast. Journal of Bone & Joint Surgery - American Volume 1962;44(2):33751. Seitz 1993 Seitz WH Jr. External xation of distal radius fractures. Indications and technical principles. Orthopedic Clinics of North America 1993; 24(2):25564. Singer 1998 Singer BR, McLauchlan GJ, Robinson CM, Christie J. Epidemiology of fractures in 15,000 adults: the inuence of age and gender. Journal of Bone and Joint Surgery - British Volume 1998; 80(2):2438. Smith 1988 Smith RJ, Floyd WE. Smiths and Bartons fractures. In: Barton N editor(s). Fractures of the hand and wrist. Edinburgh: Churchill Livingstone, 1988:25266. Stewart 1984 Stewart HD, Innes AR, Burke FD. Functional cast-bracing for Colles fractures. A comparison between cast-bracing and conventional plaster casts. Journal of Bone & Joint Surgery - British Volume 1984;66(5):74953. Stewart 1985 Stewart HD, Innes AR, Burke FD. Factors affecting the outcome of Colles fracture: an anatomical and functional study. Injury 1985; 16(5):28995. Taleisnik 1984 Taleisnik J, Watson HK. Midcarpal instability caused by malunited fractures of the distal radius. Journal of Hand Surgery - American Volume 1984;9(3):3507. Van der Linden 1981 Van der Linden W, Ericson R. Colles fracture. How should its displacement be measured and how should it be immobilized?.
28
Journal of Bone & Joint Surgery - American Volume 1981;63(8): 12858. Van Staa 2001 Van Staa TP, Dennison EM, Leufkens HG, Cooper C. Epidemiology of fractures in England and Wales. Bone 2001;29(6): 51722. Indicates the major publication for the study
29
CHARACTERISTICS OF STUDIES Characteristics of included studies [ordered by study ID]

Abbaszadegan 1990 Methods Method of randomisation not stated Assessor blinding: not reported Intention-to-treat analysis: possible (5 in POP group analysed separately but data given) Loss to follow up: 1 died in Ext-x group Teaching hospital, Sweden 47 participants Inclusion criteria: severely displaced Colles fracture, displaced (= or > 5 mm radial shortening) distal radial fracture (Older type 3 and 4), patient consent Exclusion criteria: age > 75 years, addicts, mental incapacity, neuromuscular disturbance or warfarin treatment Classication: Older (type 3 and 4) (extra- and intra-articular) Sex: 36 female Age: mean 63 years; range 22 - 75 years Assigned: 23/24 [Ext-x / POP] Assessed: 22/24 (at 1 year) Timing of intervention: not stated, but after X-ray examination (1) External xation: closed reduction under local anaesthesia, temporary dorsal plaster cast. External Hoffman xator applied at 1 to 3 days under regional anaesthesia: 2 pins inserted through 1 cm skin incision through middle of second metacarpal and 2 pins in radius. Fixator removed at 4 weeks (mean 31 days) (2) Conservative treatment: closed manipulation under local anaesthesia, then below elbow plaster cast for 4 weeks (mean 31 days) Length of follow up: 1 year; also assessed at 10-12 days, 4, 8, 12 and 24 weeks. (1) Functional: subjective function (VAS: 0 to 10: normal), overall grading (Lidstrom 1959) including activities of daily living, pain, loss of motion and deformity. Pain (VAS 0 to 10: worst), grip strength, range of movement (exion, extension, radial deviation, ulnar deviation, forearm rotation). (2) Clinical: complications: redislocation resulting in secondary external xation, pin track infection (all resolved), osteomyelitis (none), pin loosening (none), transient sensory disturbance of the supercial radial nerve. (3) Anatomical: X-ray initially, at reduction, after 10-12 days, 4 and 8 weeks. Radial shortening and dorsal angulation. Five in plaster group required remanipulation and had external xation. Separate data were provided for this group.
Participants
Interventions
Outcomes
Notes
Risk of bias Item Allocation concealment? Authors judgement Unclear Description B - Unclear
30
Hegeman 2004 Methods Randomised by random selection of envelopes containing a piece of paper with the treatment allocation Assessor blinding: not reported Intention-to-treat analysis: likely Loss to follow up: probably none Teaching hospital, The Netherlands 32 participants Inclusion criteria: unstable intra-articular distal radial fracture (> 10 degrees dorsal angulation and < 20 degrees radial inclination and > 3 mm positive ulnar variance) (AO C2 or C3). Age 55 to 80 years. Exclusion criteria: previous distal radial fracture or unable to perform functional evaluation Classication: AO (type C2 or C3) (all intra-articular) Sex: 29 female Age: mean 70 years Assigned: 15/17 [Ext-x / POP] Assessed: 15/17 (at 1 year) Timing of intervention: not stated, but after X-ray examination (1) External xation: reduction then application of Hoffmann II compact external xator: 2 pins inserted into the second metacarpal and 2 pins in radial shaft. Fixator removed after 6 weeks (2) Conservative treatment: closed manipulation then below elbow plaster cast for 6 weeks Physiotherapy started after 6 weeks. Length of follow up: 1 year; also assessed at 6 weeks, and 3 and 6 months. (1) Functional: problems in daily life (lifting cup, wringing, ne hand co-ordination, heavy load bearing), overall grading (Gartland 1951) including subjective evaluation of impairment, range of motion, residual deformity and complications. Pain (in joints), grip strength (hand and index nger), range of movement (exion, extension, radial deviation, ulnar deviation, pronation, supination). (2) Clinical: complications: complications of plaster immobilisation (loose plaster; swollen thumb), pin track infection, transient neuropraxia, RSD, Dupuytren contracture. Deformity: prominent dinner fork deformity, radial deviation of hand. (3) Anatomical: X-ray initially, after treatment, and all follow-up times. Radial shortening, radial inclination, dorsal angulation, ulnar variance. Intra-articular alignment: step off. Details on method of randomisation and plaster cast complications received from Dr Hegeman on 10 October 2006.
Participants
Interventions
Outcomes
Notes
Risk of bias Item Allocation concealment? Authors judgement Unclear Description B - Unclear
31
Horne 1990 Methods Method of randomisation not stated Assessor blinding: not reported Intention-to-treat analysis: no, baseline information or interim results not given for 8 participants; discrepancies in numbers followed in the two groups Loss to follow up: 5 lost and 3 dead by nal follow up (4 to 15 months) Teaching hospital, New Zealand 37 participants Inclusion criteria: displaced fractures of the distal radius judged as requiring reduction by resident on call. Age > 60 years. Informed consent. (Implied Colles fractures.) Exclusion criteria: none stated Classication: Frykman (included Frykman 1, 2, 3, 4, 5 and 8) (extra- and intra-articular) Sex: not given Age: of 29 analysed, mean 72 years, range 61 - 91 years Assigned: ?/? [Ext-x / POP] Assessed: 15/14 or 16/13 (see notes) (at nal follow up 4-15 months) Timing of intervention: not stated but after presentation at fracture clinic; patients in the surgical group were admitted to a day-care facility. (1) External xation: closed reduction under ischaemic arm block then modied AO tubular external xator for 5 weeks: 2 pins placed at right angles in 2nd metacarpal, 2 pins placed at right angles into dorsoradial aspect of distal radius. Stab incisions of pins. (2) Conservative treatment: closed reduction under ischaemic arm block then below-elbow backslab, 1015 degrees palmar exion and ulnar deviation, for 5 weeks. Physiotherapy afterwards if wrist or hand stiffness. Length of follow up: 4 to 15 months; also assessed at 1 and 5 weeks. (1) Functional: overall grading (not referenced but seems to be Stewart 1985, modication of Gartland 1951) including subjective (pain, disability, activity restriction, movement limitation) and objective (range of movement, nger exion, grip strength, radial/median neuritis) measures. (2) Clinical: complications: remanipulation (none), pin track problems (21%), radial nerve neuritis (26%), RSD (none) (3) Anatomical: X-ray initially, at reduction, and nal follow-up. Dorsal displacement and radial displacement (Van der Linden 1981). Abstract (Devane 1988) gives an inconsistent report of trial: 34 patients, minimum 6 months followup, some correlation between radiological result and functional outcome, external xation group held reduction signicantly better, no mention of radial nerve irritation. Highly critical letter from Axelrod 1991. Comments on entry criteria (how displaced were the fractures?), length of follow up, advised small open incisions instead of percutaneous pinning. Response from Horne did not address these issues. Numbers at nal follow up in each group varied in the main trial report (15/14 or 16/13). The two measures of displacement: dorsal displacement and radial displacement (Van der Linden 1981) are not in common use and prevent comparison with other trials.
Participants
Interventions
Outcomes
Notes
Risk of bias Item Authors judgement Description
32
Horne 1990
(Continued)
Allocation concealment? Howard 1989 Methods
Unclear
B - Unclear
Method of randomisation not stated Assessor blinding: not reported; independent assessment of functional and 10 year radiological outcome Intention-to-treat analysis: likely Loss to follow up: 6 (or 7) lost and 4 dead at 10 years General hospital, UK 50 participants Inclusion criteria: severely displaced (30 degrees of dorsal angulation or over 10 mm radial shortening) comminuted Colles fracture Exclusion criteria: age > 75 years Classication: not stated (intra-articular denitely included) Sex: not given (both sexes) Age: mean 47 years Assigned: 25/25 [Ext-x / POP] Assessed: 21/19 (or 21/18) (at 10 years) Timing of intervention: not stated, but probably soon after hospital admission; surgery was usually done on the next available trauma list. (1) External xation: medium-C Hoffman external xator: 2 pins inserted into middle of 2nd and 3rd metacarpals, 2 into radial shaft. Fixator locked after reduction (under image intensier). Removed after 5 to 6 weeks. (2) Conservative treatment: closed manipulation under Biers block and below-elbow backslab, completed next day (remanipulation if initial reduction was unsatisfactory). Plaster cast for 5 to 6 weeks. All had physiotherapy afterwards. Length of follow up: 10 years (mean 10.25 years); also assessed at 1, 2, 5 and 13 weeks and 6 months. (1) Functional: overall grading (Gartland 1951; Stewart 1984) including subjective (pain, disability, activity restriction, movement limitation) and objective (range of movement, nger exion, grip strength, radial/median neuritis) measures. (2) Clinical: complications: remanipulation, xator distraction increased, pin track infection, radial nerve neuritis, Sudecks atrophy (none), tendon (EPL) rupture, median nerve compression, ulnar nerve compression, osteoarthritis. Cosmetic appearance, patient satisfaction, osteoarthritis (3) Anatomical: X-ray initially, at reduction, and all follow-up times. Dorsal angulation, radial shift, radial shortening and radial deviation. Overall anatomical score (Stewart 1984), radiological deformity (Dias 1987), arthritis (Knirk and Jupiter 1986) Anatomical results presented graphically in main paper. 10 years follow up reported in two separate abstracts (Freeman 1998; Freeman 2000). Slight discrepancies between the two abstracts in the numbers lost to follow up at 10 years and nal functional result for the xation group.
Participants
Interventions
Outcomes
Notes
33
Howard 1989
(Continued)
Allocation concealment? Jenkins 1989 Methods
Unclear
B - Unclear
Randomised by date of birth Assessor blinding: not done Intention-to-treat analysis: problems including disparities in reported inclusion criteria and 24 excluded from analyses, including 17 with follow up < 12 months after fracture union, 3 allocated external xation (2 had premature removal of xator due to recurrent infections and 1 had an iatrogenic radial shaft fracture) and 4 allocated plaster casts who were given external xation after remanipulation. Loss to follow up: 29 (including 24 exclusions) Teaching hospital, UK 153 participants Inclusion criteria: displaced distal radial fracture (Colles fractures) requiring manipulation, unilateral, age < 65 years (or < 60 years in journal publications: see Notes) Exclusion criteria: radiographic evidence of osteoporosis Classication: Frykman (extra- and intra-articular) Sex: not given Age: mean 44 years Assigned: 84/69 [Ext-x / POP] Assessed: 68/56 (13+ months) Timing of intervention: probably reduction at fracture clinic, external xation on day of injury or next day. (1) External xation: closed reduction and usually overnight hospital admission (tended to be day cases later on in trial) for AO/ASIF external mini-xator (in Z or box conguration) application under general anaesthesia. Two proximal Kirschner wires at right angles into radial shaft (stab incisions) and 2 distal wires at right angles transxed comminuted distal fragments. Insertion under image intensied using a power drill. Wrist usually mobile but no physiotherapy. Fixator removed after 4 weeks. (2) Conservative treatment: closed manipulation under intravenous sedation, then dorsal plaster slab, completed at 1 week. Cast removed after 4 weeks. Crepe bandage and mobilisation. Immobilisation increased by one week if non-union at 4 weeks. There was no formal physiotherapy. Length of follow up: 13 months (12 months after union); also assessed at 1 and 4 weeks and 2 and 4 months. (1) Functional: range of movement (exion, extension, radial and ulnar deviation, pronation, supination) , mass grip strength. Overall grading (Stewart 1985, modication of Sarmiento) including subjective and objective outcomes. (2) Clinical: complications (* = no data given for POP group): remanipulation (4 in POP group in Masters thesis but 6 in 1988 report), pin track infection, serious infection (recurrent and deep), osteomyelitis, premature frame removal, pin site fracture (radial shaft), median nerve compression (none), sensory changes in supercial radial nerve (11 of which 2 permanent in Ext-x group), ulnar nerve problems (none), unstable distal radial-ulnar joint restricting supination* (2 of 3 had reconstructive surgery, RSD (2/24 of the POP group had shoulder-hand syndrome in the 1987 report) (3) Anatomical: measured at post reduction, union (4 weeks), and 1 and 13 months post union. Dorsal angulation, radial shortening, radial length. Overall and changes in anatomical grading (Stewart 1985)
34
Participants
Interventions
Outcomes
Jenkins 1989
(Continued)
Notes
Initially, in the rst version of the overall review, this trial was reported as 2 trials: Jenkins 1987 and Jenkins 1988. Similarities were noted and we suggested that there may be shared patients. This was conrmed on communication with the lead trialist who indicated that these were both pilot studies in an overall larger study which formed his Masters thesis. In Handoll 2003a, the results presented in this thesis replaced those presented previously. There were several inconsistencies noted between the various trial reports. One is that the upper age limit was stated to be 60 years in the journal publications and 65 years in the thesis. Another is that there were 6 remanipulations in the POP group registered in the 1988 report but only 4 (all leading to external xation and subsequent exclusion from the analyses) in the thesis. It is likely that the date of last follow up was set up as at least 12 months from union, rather than exactly 12 months from union, and some participants may have been followed up for 3 years.
Risk of bias Item Allocation concealment? Authors judgement No Description C - Inadequate
Kapoor 2000 Methods Method of randomisation not stated Assessor blinding: not reported Intention-to-treat analysis: not known, loss to follow up deduced from paper Loss to follow up: 20 (at 4 years) Teaching hospital, India 61 participants (in review comparison: see Notes) Inclusion criteria: acute displaced intra-articular distal radius fracture, adult. Dorsal or volar displacement. Exclusion criteria: not given Classication: Frykman 3, 4, 7 & 8 (and AO) (intra-articular) Sex: 15 female Age: mean 39 years (of 90) Assigned: 28/33 [Ext-x / POP] Assessed: 18/23 (at 4 years) Timing of intervention: not stated, but acute injury. (1) External xation: Roger and Anderson external frame xator: 2 pins into 2nd and 3rd metacarpals, 2 into radius shaft. Patients encouraged to use limb (eating etc) and rotate forearm. Fixator removed 6-7 weeks. Splint for 2 days after removal of xator, then mobilisation. (2) Conservative treatment: closed reduction and plaster cast. Remanipulated once if necessary. Immobilisation for 6 to 7 weeks. Length of follow up: average 4 years; also assessed at 1 week and 6 to 7 weeks (certainly Ext-x and POP groups). (1) Functional: overall grading (Sarmiento 1975) including subjective evaluation, objective evaluation, residual deformity, and complications. Range of movement (exion, extension, radial deviation, ulnar deviation, pronation, supination). (2) Clinical: complications: redisplacement (not enumerated), pin track infection, CTS (resolved), nger
35
Participants
Interventions
Outcomes
Kapoor 2000
(Continued)
stiffness (all resolved), RSD (resolved). Residual cosmetic deformity (3) Anatomical: X-ray at reduction, and probably other times (see above). Radial shortening, dorsal tilt, volar angulation, articular step off. Overall grading (no reference) Notes Trial with 90 participants had 3 intervention groups. Excluded from this review are the 29 participants receiving open reduction and internal xation using Kirschner wires, small T-plates or both. 70% of the whole trial population had fractures resulting from a road trafc accident. Discrepancies between functional grading in Table 2 and account in report abstract.
Risk of bias Item Allocation concealment? Kreder 2006 Methods Randomised by sealed opaque sequentially marked envelopes based on computer-generated random number sequences Assessor blinding: no (although independent research assistants) Intention-to-treat analysis: likely Loss to follow up: 28 3 teaching hospitals, Canada 113 participants Inclusion criteria: displaced distal radial fracture with metaphyseal comminution but without joint incongruity. Skeletally mature, aged 16 to 75 years. Stable congruous joint. Patient consent. Exclusion criteria: comminution > 1/3rd the anterior-posterior diameter of radius, dorsal tilt > 10 degrees, detectable step or gap at joint surface, history of previous wrist fracture, congenital anomaly or other severe wrist problem, not t for surgery, denitive treatment could not be administered within 1 week, mentally incompetent, unable to write in English. Open fracture, associated ipsilateral extremity injuries, other signicant system injuries. Classication: AO (extra- and intra-articular) Sex: 74 female Age: mean 53 years Assigned: 54/59 [Ext-x / POP] Assessed: 44/41 (at 2 years) Timing of intervention: within 1 week of injury. (1) External xation: closed reduction under regional anaesthesia. Application of the small spanning AO xator: 2.5 mm pins into 2nd metacarpal and 4 mm pins into radius via 1 cm skin incision. Additional (in 19 cases) smooth Kirchner wires inserted from the radial styloid or dorsum of the radius across the fracture fragments at surgeons discretion. Optional wires removed 4 to 6 weeks. Fixator removed between 6 to 8 weeks. (2) Conservative treatment: closed reduction under haematoma block (and uoroscopy), then long arm splint with wrist in neutral and elbow at 90 degrees - reduction repeated if necessary. Splint converted to long arm cast within 14 days, reduced to short arm cast at 3 to 4 weeks, removed 6 to 8 weeks. Finger exercises during xator or cast use, and wrist exercises post immobilisation. All participants received
36
Authors judgement Unclear
Description B - Unclear
Participants
Interventions
Kreder 2006
(Continued)
supervised physiotherapy [until maximum range of motion was achieved]. Outcomes Length of follow up: 2 years; also assessed at 1, 2, 3, 4 and 6 weeks, and 6 and 12 months. (1) Functional: Musculoskeletal Function Assessment (upper extremity) and SF-36 (bodily pain domain) questionnaires. Job change because of injury. Jebsen Taylor hand function (Jebsen 1969); grip, pinch, pad and chuck strengths; range of movement (exion, extension, radial deviation, ulnar deviation, pronation, supination). (2) Clinical: complications: secondary treatment resulting from redisplacement (open reduction and internal xation for I Ext-x and external xation for 5 POP); distal radial ulnar joint instability (one Ext-x had ulnar styloid repair), pin track infection, supercial infection, deep infection, RSD. (3) Anatomical: X-ray at reduction, and other times up to 6 months (see above). Union, radial shortening and palmar tilt restoration. Further details of method of randomisation and rehabilitation received from Julie Agel on 10 October 2006. Some percentages in Table 1 in the trial report giving baseline data and results did not correspond to stated numbers available at baseline or at follow up times.
Notes
Risk of bias Item Allocation concealment? Authors judgement Yes Description A - Adequate
Lagerstrom 1999 Methods Randomised using computer, within 6 unit blocks Assessor blinding: not reported Intention-to-treat analysis: problems including 2 exclusions. Five in POP group who received secondary external xation were analysed separately; data from the 5 males in the Ext-x group also remove from the analyses of grip strength Loss to follow up: 2 (excluded) Teaching hospital, Sweden 35 participants Inclusion criteria: displaced (3+ mm radial shortening; 10+ degrees dorsal or 10+ degrees radial angulation of the radius) distal intra-articular Colles fracture involving distal radio-ulnar joint. Age 45 to 75 years. Feasible to use plaster cast or external xator Exclusion criteria: medical conditions or language difculties that might interfere with outcome. Classication: Frykman (5 to 8) (intra-articular) Sex: 30 female Age: mean 58 years; range 45 - 72 years (of 33) Assigned: 18/17 [Ext-x / POP] Assessed: 16/15 (at 2 years) Timing of intervention: not stated. No mention of method of reduction. (1) External xation: light (in weight) non-cylindrical AO external xator. Immobilised for 6 weeks. (2) Conservative treatment: cylindrical below elbow plaster cast for 6 weeks.
37
Participants
Interventions
Lagerstrom 1999
(Continued)
Physiotherapy started soon (same day or next day) after fracture had been immobilised, in both groups. Outcomes Length of follow up: 2 years; also assessed at up to 10 days, 6, 10 and 18 weeks and 1 year. (1) Functional: grip strength, and pain during grip measurements. (2) Clinical: complications: redisplacement requiring treatment change, refracture. (3) Anatomical: no information. Redisplacement with 10 days. Five in POP group required remanipulation and had external xation. This group was analysed separately. Separate analyses were also undertaken for the 5 male patients, all in the external xation group.
Notes
Risk of bias Item Allocation concealment? McQueen 1996 Methods Randomised by closed envelopes Assessor blinding: not reported Intention-to-treat analysis: likely Loss to follow up: 8 (at 1 year) Teaching hospital, UK 90 participants (in review comparison: see Notes) Inclusion criteria: redisplaced unstable distal radial fracture (redisplaced to >10 degrees dorsal angulation or radial shortening > 3 mm) Exclusion criteria: inadequate primary reduction, > 2 weeks from injury to recognised instability, displaced articular fragments requiring open reduction, previous malunion, mental incapacity Classication: AO (A and C) (extra-articular and intra-articular) Sex: 81 female Age: mean 63 years, range 16 - 86 years (of 120 patients) Assigned: 30/30/30 [Ext-x / Ext-x with early mobilisation / POP] Assessed: 28/26/28 (at 1 year) Timing of intervention: under 2 weeks from injury (1) External xation: closed reduction and Pennig external xator. Two pins inserted into 2nd metacarpal and 2 into radial shaft using an open technique. Ball joint locked. Fixator removed after 6 weeks. (2) External xation: as above (1) but release of ball joint of xator at 3 weeks to allow wrist movement. (3) Conservative treatment: closed manipulation, then forearm cast for 6 weeks. Physiotherapy prescribed on purely clinical grounds. Patients did not receive physiotherapy when the xator was in place. Length of follow up: 1 year; also assessed at 6 weeks, 3 and 6 months. (1) Functional: activities of daily living (own scale), mass grip strength, other grips, pain (VAS 0 to 10: no data), range of movement (overall, exion and extension). (2) Clinical: complications: recurrent instability, malunion, pin track infection, RSD, CTS, dorsal medial
38
Participants
Interventions
Outcomes
McQueen 1996
(Continued)
neuropraxia (supercial radial nerve?), EPL rupture (none), carpal collapse. (3) Anatomical: X-ray at all follow-up times. Dorsal angulation, radial shortening, carpal malalignment, malunion. Notes Trial with 120 participants had 4 intervention groups. Excluded from this review are the 30 participants receiving open reduction and bone graft held in place with a single Kirschner wire.
Risk of bias Item Allocation concealment? Pring 1988 Methods Method of randomisation not stated Assessor blinding: not reported, two assessors worked independently of each other Intention-to-treat analysis: No, the results from 9 people allocated plaster cast but treated with external xation after redisplacement were stated as being put into a separate group for purposes of analysis. They were presented in the surgical group for surgical complications. Loss to follow up: 9 (at 6 months) District general hospital, UK 75 participants with 76 fractures Inclusion criteria: Colles fracture, displaced distal radius fracture Exclusion criteria: not stated Classication: extra- and intra-articular Sex: 61 female Age: mean 62 years Assigned: 36/39 (40 fractures) [Ext-x / POP] Assessed: ?/? (66 available at 6 months) Timing of intervention: not stated, but at accident and emergency department after closed reduction via traction using nger traps under a haematoma block (1) External xation: bipolar xation. Two half pins inserted percutaneously into the radial shaft and secured in both cortices and one pin through the thumb metacarpal at 90 degrees to the radial pins. Pins incorporated into a padded forearm cast with wrist in neutral position. (2) Conservative treatment: plaster of Paris forearm cast applied under traction with wrist in neutral position and forearm pronated. In both groups, the completed casts were split down the ulnar border. Early hand function was encouraged. If necessary, participants attended a daily hand class before and after cast removal, which was after 5 weeks. Length of follow up: 6 months; also assessed at 1, 2, 5, 7 and 12 weeks. (1) Functional: overall grading (Scheck 1962: based on Gartland 1951) included subjective evaluation, wrist appearance, wrist and nger movements, grip, radiological assessment. Grip strength. (2) Clinical: complications: redisplacement (all in POP group treated with external xation). All those (45) who had external xation including 9 people allocated POP: thumb pain (9 ), migrated pin (1), fracture through pin hole (1), pin loosening or infection (7)
39
Participants
Interventions
Outcomes
Pring 1988
(Continued)
(3) Anatomical: X-ray at reduction, 1, 2, 5 and 12 weeks. Radial length, volar angle, radial angle. Notes Risk of bias Item Allocation concealment? Rodriguez-Merchan 92 Methods Method of randomisation not stated, claimed to be double-blind Assessor blinding: not stated Intention-to-treat analysis: likely Loss to follow up: probably none Teaching hospital, Spain 70 participants Inclusion criteria: comminuted intra-articular distal radial fracture, Frykman 3 to 8 Exclusion criteria: > 45 years Classication: Frykman (3 to 8) (intra-articular) Sex: 12 female Age: mean 36 years; range 20 - 45 years Assigned: 35/35 [Ext-x / POP] Assessed: 35/35 (1 year) Timing of intervention: probably reduction on rst day, external xation on rst or next day. (1) External xation: reduction under general anaesthesia or brachial block. Clyburn dynamic external xator: 2 pins driven into radial diaphysis and 2 into diaphysis of 2nd metacarpal. Overnight hospital admission. Posterior splint applied for 3 weeks if joint disrupted; transverse pin inserted for 3 weeks if joint unstable. Device removed after 7 weeks. Pin sites dressed by medical staff at weekly intervals (2) Conservative treatment: closed manipulation under local anaesthesia, then forearm plaster. Remanipulation at 1 week if position unacceptable. Total 7 weeks, unless problems when kept for 1 more week. Before discharge, patients were given instructions to mobilise ngers and shoulder. Length of follow up: 1 year; also assessed at 1, 3 and 7 weeks. (1) Functional: overall grading (Horne 1990, thus probably based on Stewart 1985) based on subjective and objective outcomes. (2) Clinical: complications: remanipulation (offered), pin track infection, pin loosening, premature frame removal (none), joint infection (none), osteomyelitis (none), pin breakage (none), RSD (Sudecks atrophy requiring intensive physiotherapy), tendon or nerve injuries (none), non-union (none) (3) Anatomical: X-ray at 1, 3 and 7 weeks. Dorsal angulation, radial shortening, radial length. Overall grade (Stewart 1985 based on Lidstrom 1959 and Sarmiento 1975) First author listed as Merchan ECR in article. Journal is now American Journal of Orthopedics. Authors judgement Unclear Description B - Unclear Preliminary results presented at a conference (Pring 1986) were for 51 participants.
Participants
Interventions
Outcomes
Notes Risk of bias
40
Rodriguez-Merchan 92
(Continued)
Item Allocation concealment? Roumen 1991 Methods
Method of randomisation not stated Assessor blinding: not reported Intention-to-treat analysis: not known, but some of the 19 patients who had died (2) or were lost to follow up (17) from the original study group may have belonged to the randomised trial. Lost to follow up: not known - see above General hospital, The Netherlands 43 participants followed up Inclusion criteria: redisplaced Colles fracture with dorsal angulation > 10 degrees or radial shortening > 5 mm. Age > 55 years (all intra-articular) Exclusion criteria: not stated Classication: Frykman and Sarmiento (intra-articular) Sex: not given (predominantly female) Age: not given, > 55 years Assigned: ?/? reported 21/22 [Ext-x / POP] Assessed: 21/22 (6 months) Timing of intervention: all patients had initial fracture reduced, within 6 hours of injury, under local anaesthesia and treated with plaster backslab, which we assume was completed to a forearm plaster cast. Seen 1, 7 and 14 days. Allocation at 2 weeks if fracture redisplaced (see inclusion criteria). (1) External xation: fracture remanipulated under regional anaesthesia and Ace Colles external xator applied for 5 weeks (2) Conservative treatment: forearm plaster cast continued for a further 5 weeks Length of follow up: 6 months; also assessed post manipulation and 5 weeks on removal of plaster cast or xator. (1) Functional: overall grading by de Bruijn 1987 and Lidstrom 1959 systems, pain (at rest, on movement, on ulnar pressure), grip strength. (2) Clinical: complications: pin loosening, pin track infection (none), RSD (serious RSD: 2/1), CTS (no data), tenosynovitis (no data), EPL rupture. Cosmetic appearance: specially not noted. (3) Anatomical: X-ray post re-MUA and on removal of plaster cast or external xator. Overall grading Lidstrom 1959 and Sarmiento 1980. Also volar angle, radial shortening, radial angle and radial shift. A third group of patients who did not have redisplacement at 2 weeks were also followed up.
Participants
Interventions
Outcomes
Notes Risk of bias Item Allocation concealment?
41
Stein 1990 Methods Randomised by day of hospital admission Assessor blinding: not reported Intention-to-treat analysis: not known Lost to follow up: not stated, perhaps none Teaching hospital, Israel 62 participants Inclusion criteria: displaced comminuted distal radial fracture (Older type 3 and 4: Colles fracture). Shortening of distal radius 1 to 4 mm below distal ulna (Older type 3) or greater. Exclusion criteria: none stated Classication: Older (type 3 and 4) (all intra-articular) Sex: not given Age: mean 50 years; range 19 - 79 years Assigned: 40/22 [Ext-x / POP] Assessed: 40/22 Timing of intervention: not stated but after presentation at fracture clinic; participants of the surgical group were either admitted into hospital for 24 hours or to a day-care facility. Fractures reduced under regional or general anaesthesia. (1) External xation: closed reduction then the small AO external tubular xator, usually for 6 weeks: 2 pins placed in 2nd metacarpal, 2 pins placed into radial shaft. (2) Conservative treatment: closed reduction then above-elbow plaster cast with the forearm in pronation, usually for 6 weeks. Length of follow up: 6 months to 4 years (mean 3 years); also assessed at 1, 2, 4 and 6 weeks. (1) Functional: overall grading split by subjective (pain, deformity, grip strength, inability to return to previous activities) and objective results using Gartland 1951. (2) Clinical: complications: remanipulation, pin track infection (all resolved), pin loosening, breakage (none), osteomyelitis (none), supercial radial nerve irritation (temporary), RSD (3) Anatomical: X-ray initially and at all follow-up times. Dorsal angulation, radial shortening, radial angulation and shift. Overall grading of deformity (Van der Linden 1981). Results for another 64 patients with extra-articular fractures were treated with an above-elbow plaster cast were also presented in the trial report. However, these were not part of the trial.
Participants
Interventions
Outcomes
Notes
Risk of bias Item Allocation concealment? Authors judgement No Description C - Inadequate
42
Young 2003 Methods Randomised using closed envelopes Assessor blinding: not reported (independent physiotherapist at 7 years) Intention-to-treat analysis: losses accounted for. (Late decision to exclude data for a person with rheumatoid arthritis) Loss to follow up: 39 (at 7 years) General hospital, UK 125 participants Inclusion criteria: displaced Colles fracture, unilateral, dorsal angulation > 10 degrees, radial shortening > 2 mm, age 16 - 75 years Exclusion criteria: bilateral fracture, associated fractures of ipsilateral limb, die punch fractures, multiple injuries, unable to understand purpose of study Classication: Frykman (extra-articular and intra-articular) Sex: 97 female Age: mean 57 years; range 16 - 75 years Assigned: 59/66 [Ext-x / POP] Assessed: 48/60 (at 1 year); 36/50 or 36/49 (at 7 years) Timing of intervention: not stated (1) External xation: manipulation and application of bridging Pennig dynamic xator under general anaesthesia. Pins inserted percutaneously into 2nd metacarpal and under direct vision into the radial shaft. Distal ball joint unlocked at 3 weeks, xator removed at 6 weeks (2) Conservative treatment: manipulation under regional or general anaesthesia and application of below elbow plaster backslab; then completed to full below-elbow plaster cast at 1 week and removed at 6 weeks Length of follow up: 7 years (mean 7.8 years); also assessed at 1, 2, 6 and 9 weeks, 3, 6, 12 and 18 months and 2 years. (1) Functional: difculties in two aspects of activities of daily living, grip strength, range of movement ( pronation, supination, exion, extension, radial and ulnar deviation) from 9 weeks onwards. Use of wrist splint. Persistent wrist pain (1 in conservative group had rheumatoid arthritis at 7 years). Time to return to normal activities and work. Overall grades (Gartland 1951) at 7 years. (2) Clinical: complications: redisplacement by 2 weeks, remanipulation, malunion, median nerve neuropathy, pin site infection (all supercial), radial nerve neuropathy, RSD (including 1 versus 3 persistent at 1 year, and 1 versus 0 at 7 years), EPL tendon rupture, osteoarthritis (signs: just one with symptoms). Patient satisfaction, unsightly forearm scars (from external xator) (3) Anatomical: X-ray initially, pre-operatively at reduction and all the above times. Radial shortening, radial shift, radial and dorsal angulation. Malunion. Osteoarthritis (Knirk 1986) The full publication of the 7 year results is new to this review and is the rst full report of this trial previously only reported in abstracts. The trial appeared as Young 2002 in Handoll 2003a, and as Nanu 1994 in rst version of that review. For Handoll 2003a, Miss Young provided copies of the drafts of 3 papers, submitted for journal publication, and also provided answers to further queries. There are differences in presentation between the draft and published reports of the 7 year results. These include the general use of medians in the published report and the exclusion of data for one person with rheumatoid arthritis.
Participants
Interventions
Outcomes
Notes
43
Young 2003
(Continued)
Allocation concealment? Zheng 2003 Methods
Unclear
B - Unclear
Randomised by admission number Assessor blinding: not reported Intention-to-treat analysis: not known Lost to follow up: not stated, probably none Military (police) hospital, China 29 participants Inclusion criteria: closed unstable distal radial fracture Exclusion criteria: none stated Classication: Universal classication (Cooney) IIB, IIC (extra-articular), IVB, IVC (intra-articular) Sex: 14 female Age: range 18 - 52 years Assigned: 12/17 (if none lost to follow up) [Ext-x / POP] Assessed: 12/17 (at 1 year) Timing of intervention: not stated. Participants were either outpatients or inpatients. (1) External xation: closed (5 participants) or open (7 participants) reduction under brachial plexus block. Then application of small size Zhongjia SGD-type unilateral multifunctional external xator: 2 pins inserted through skin incisions (0.7 cm) into the second metacarpal and 2 pins through skin incisions in radial shaft. Kirschner wire added if fracture was still unstable. Wrist xed in medial position, slight extension and ulnar deviation or volar exion (opposite to the direction of the injury). Fixator made dynamic and K-wire removed from week 4. Fixator removed after 6 weeks. Immediate functional training nger mobilisation; then, nger, elbow and shoulder from week 2; wrist joint mobilisation and strengthening activities from week 4. (2) Conservative treatment: manual reduction under haematoma block with X-ray monitoring. Plaster of Paris short-arm (forearm) cast applied, position changed after 2 weeks to medial. Cast removed after 6 weeks. Functional training was done before and after removing the cast. Length of follow up: 1 year; also assessed at 2 and 6 weeks. (1) Functional: overall grading (Sarmiento 1975) including subjective evaluation of activity restriction and pain, objective evaluation of function, range of motion (loss of exion or extension rated) and grip strength. (2) Clinical: complications: loosened nail, injured supercial radial nerve, carpal tunnel syndrome. (3) Anatomical: X-ray initially, after treatment, and all follow-up times. Anatomical assessment (Stewart 1984), radial shortening, volar angulation, ulnar angulation Translated from Chinese by Xiaoyan Chen
Participants
Interventions
Outcomes
Notes Risk of bias Item Allocation concealment?
Authors judgement No
Description C - Inadequate
44
<: less than >: more than AO: Arbeitsgemeinschaft fur Osteosynthesefragen / Association for the Study of Internal Fixation (or ASIF) CTS: carpal tunnel syndrome DISI: dorsal intercalated segment instability EPL: extensor pollicis longus (tendon) Ext-x: external xation hypoaesthesia: decrease in sensation K-wires: Kirschner wires paraesthesia: numbness, tingling, pins and needles sensation POP: plaster of Paris ROM: range of movement (wrist and forearm) RSD: reex sympathetic dystrophy VAS: visual analogue scale VISI: volar intercalated segment instability X-pins: crossed percutaneous pinning References (listed above but not in Additional references) * de Bruijn 1987 de Bruijn HP. Functional treatment of Colles fracture. Acta Orthopaedica Scandinavica Supplementum 1987; 223:1-95. *Dias 1987 Dias JJ, Wray CC, Jones JM, Gregg PJ. The value of early mobilisation in the treatment of Colles fractures. Journal of Bone & Joint Surgery - British Volume 1987; 69(3):463-7. * Lidstrom 1959 Lidstrom A. Fractures of the distal end of the radius. A clinical and statistical study of end results. Acta Orthopaedica Scandinavica Supplementum 1959; 41:5-118. *Sarmiento 1975 Sarmiento A, Pratt GW, Berry NC, Sinclair WF. Colles fractures. Functional bracing in supination. Journal of Bone & Joint Surgery - American Volume 1975; 57(3):311-7. *Sarmiento 1980 Sarmiento A, Zagorski JB, Sinclair WF. Functional bracing of Colles fractures: a prospective study of immobilization in supination vs. pronation. Clinical Orthopaedics & Related Research 1980; 146:175-83.
Characteristics of excluded studies [ordered by study ID]
Christensen 2001
Not a randomised comparison. Compares treatment with external xation at one hospital with plaster cast at another hospital. Not a randomised comparison. Use of historic controls. Includes patients from a randomised trial of conservative treatment but the patients in the external xator group were not randomised. Insufcient information to include. Quasi-randomised trial (60 participants) reported only in an abstract. (Superior radiological results were reported for the external xator group). Though one trialist provided brief details of the method of randomisation (alternation) and setting (emergency department), the likelihood of getting further information or the trial ever being published seems remote. Retrospective comparison.
45
Kongsholm 1989 Solgaard 1989
Sprenger 1988
van Dijk 1996
DATA AND ANALYSES
Comparison 1. External xation versus plaster cast
Outcome or subgroup title 1 Functional grading: not excellent 2 Functional grading: not excellent. Worst and best case scenarios sensitivity analyses 2.1 Sensitivity analysis 1: worst case for plaster cast 2.2 Sensitivity analysis 2: best case for plaster cast 3 Functional grading: fair or poor 4 Subjective and objective functional evaluation 4.1 Subjective grading: not excellent 4.2 Subjective grading: fair/ poor 4.3 Objective grading: not excellent 4.4 Objective grading: fair/ poor 5 Upper extremity function part of Musculoskeletal Function Assessment tool (0 to 100: maximum disability) 5.1 At 6 months 5.2 At 1 year 5.3 At 2 years 6 Difculties in activities of daily living 6.1 Lifting cup at 3 months 6.2 Lifting cup at 1 year 6.3 Hand wringing at 3 months 6.4 Hand wringing at 1 year 6.5 Fine hand co-ordination at 3 months 6.6 Fine hand co-ordination at 1 year 6.7 Heavy load bearing at 3 months 6.8 Heavy load bearing at 1 year
No. of studies 9 9
No. of participants 521
Statistical method Risk Ratio (M-H, Fixed, 95% CI) Risk Ratio (M-H, Fixed, 95% CI)
Effect size 0.82 [0.71, 0.95] Subtotals only
9 9 11 2 1 2 1 2 1
610 610 612
Risk Ratio (M-H, Fixed, 95% CI) Risk Ratio (M-H, Fixed, 95% CI) Risk Ratio (M-H, Fixed, 95% CI) Risk Ratio (M-H, Fixed, 95% CI) Risk Ratio (M-H, Fixed, 95% CI) Risk Ratio (M-H, Fixed, 95% CI) Risk Ratio (M-H, Fixed, 95% CI) Risk Ratio (M-H, Fixed, 95% CI) Mean Difference (IV, Fixed, 95% CI)
0.64 [0.55, 0.74] 1.09 [0.95, 1.25] 0.73 [0.55, 0.98] Totals not selected Not estimable Not estimable Not estimable Not estimable Totals not selected
1 1 1 2 1 1 1 1 1 1 1 1
Mean Difference (IV, Fixed, 95% CI) Mean Difference (IV, Fixed, 95% CI) Mean Difference (IV, Fixed, 95% CI) Risk Ratio (M-H, Fixed, 95% CI) Risk Ratio (M-H, Fixed, 95% CI) Risk Ratio (M-H, Fixed, 95% CI) Risk Ratio (M-H, Fixed, 95% CI) Risk Ratio (M-H, Fixed, 95% CI) Risk Ratio (M-H, Fixed, 95% CI) Risk Ratio (M-H, Fixed, 95% CI) Risk Ratio (M-H, Fixed, 95% CI) Risk Ratio (M-H, Fixed, 95% CI)
Not estimable Not estimable Not estimable Totals not selected Not estimable Not estimable Not estimable Not estimable Not estimable Not estimable Not estimable Not estimable
46
6.9 Difculty in turning keys or taps at 7 years 6.10 Difculty in picking up small objects and turning door handles at 7 years 7 Job change because of injury 7.1 At 6 months 7.2 At 1 year 7.3 At 2 years 8 Mass grip strength (% of normal side) 8.1 Results at around 1 year 8.2 Results at 7 years follow up 9 Grip, chuck and pinch strengths (injured - normal side): units not given 9.1 Grip strength at 2 years 9.2 Chuck strength at 2 years 9.3 Pinch strength at 2 years 10 Maximal voluntary contraction: injured - uninjured side (Newtons) 10.1 Results at 18 weeks 10.2 Results at 2 years 11 Persistent pain (1 year & 7 years) 11.1 At 1 year 11.2 Radiocarpal pain at 1 year 11.3 Ulnocarpal pain at 1 year 11.4 Radioulnar pain at 1 year 11.5 At 7 years 12 Pain (6 months) 12.1 Pain at rest 12.2 Pain on movement 12.3 Ulnar compression pain 13 Range of movement at 1 year (% of normal side) 13.1 Flexion 13.2 Extension 13.3 Radial deviation 13.4 Ulnar deviation 13.5 Supination 13.6 Pronation 13.7 Flexion/extension 13.8 Overall range of movement 14 Range of movement at 2 years (injured - normal side) 14.1 Flexion (degrees) 14.2 Extension (degrees)
1 1
Risk Ratio (M-H, Fixed, 95% CI) Risk Ratio (M-H, Fixed, 95% CI)
Not estimable Not estimable
1 1 1 1 4 4 1 1
Risk Ratio (M-H, Fixed, 95% CI) Risk Ratio (M-H, Fixed, 95% CI) Risk Ratio (M-H, Fixed, 95% CI) Risk Ratio (M-H, Fixed, 95% CI) Mean Difference (IV, Random, 95% CI) Mean Difference (IV, Random, 95% CI) Mean Difference (IV, Random, 95% CI) Mean Difference (IV, Random, 95% CI)
Totals not selected Not estimable Not estimable Not estimable Totals not selected Not estimable Not estimable Totals not selected
1 1 1 1
Mean Difference (IV, Random, 95% CI) Mean Difference (IV, Random, 95% CI) Mean Difference (IV, Random, 95% CI) Mean Difference (IV, Random, 95% CI)
Not estimable Not estimable Not estimable Totals not selected
1 1 2 1 1 1 1 1 1 1 1 1 3 2 2 1 1 1 1 1 1 1 1 1
Mean Difference (IV, Random, 95% CI) Mean Difference (IV, Random, 95% CI) Risk Ratio (M-H, Fixed, 95% CI) Risk Ratio (M-H, Fixed, 95% CI) Risk Ratio (M-H, Fixed, 95% CI) Risk Ratio (M-H, Fixed, 95% CI) Risk Ratio (M-H, Fixed, 95% CI) Risk Ratio (M-H, Fixed, 95% CI) Risk Ratio (M-H, Fixed, 95% CI) Risk Ratio (M-H, Fixed, 95% CI) Risk Ratio (M-H, Fixed, 95% CI) Risk Ratio (M-H, Fixed, 95% CI) Mean Difference (IV, Fixed, 95% CI) Mean Difference (IV, Fixed, 95% CI) Mean Difference (IV, Fixed, 95% CI) Mean Difference (IV, Fixed, 95% CI) Mean Difference (IV, Fixed, 95% CI) Mean Difference (IV, Fixed, 95% CI) Mean Difference (IV, Fixed, 95% CI) Mean Difference (IV, Fixed, 95% CI) Mean Difference (IV, Fixed, 95% CI) Mean Difference (IV, Fixed, 95% CI) Mean Difference (IV, Fixed, 95% CI) Mean Difference (IV, Fixed, 95% CI)
Not estimable Not estimable Totals not selected Not estimable Not estimable Not estimable Not estimable Not estimable Totals not selected Not estimable Not estimable Not estimable Totals not selected Not estimable Not estimable Not estimable Not estimable Not estimable Not estimable Not estimable Not estimable Totals not selected Not estimable Not estimable
47
14.3 Radial deviation (degrees) 14.4 Ulnar deviation (degrees) 14.5 Supination (degrees) 14.6 Pronation (degrees) 15 Range of movement at 1 year 15.1 Flexion (degrees) 15.2 Extension (degrees) 15.3 Radial deviation (degrees) 15.4 Ulnar deviation (degrees) 15.5 Supination (degrees) 15.6 Pronation (degrees) 16 Range of movement at 7 years 16.1 Flexion (degrees) 16.2 Extension (degrees) 16.3 Radial deviation (degrees) 16.4 Ulnar deviation (degrees) 16.5 Supination (degrees) 16.6 Pronation (degrees) 17 Complications 17.1 Redisplacement / recurrent instability 17.2 Redisplacement resulting in secondary treatment 17.3 Distal radial ulnar joint instability 17.4 Plaster cast problems (swollen thumb; loose plaster) 17.5 Pin track infection 17.6 Pin loosening and other pin site problems 17.7 Premature frame/xator removal 17.8 Osteomyelitis 17.9 Wound infection 17.10 Tendon injury/rupture 17.11 Dorsal medial neuropraxia 17.12 Transient neuropraxia 17.13 Median nerve compression /Carpal tunnel syndrome 17.14 Radial nerve neuritis or neuropathy 17.15 Supercial radial nerve paraesthesia or injury 17.16 Ulnar nerve compression
1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 15 5 9 1 1 11 7 3 4 1 5 1 1 6
Mean Difference (IV, Fixed, 95% CI) Mean Difference (IV, Fixed, 95% CI) Mean Difference (IV, Fixed, 95% CI) Mean Difference (IV, Fixed, 95% CI) Mean Difference (IV, Fixed, 95% CI) Mean Difference (IV, Fixed, 95% CI) Mean Difference (IV, Fixed, 95% CI) Mean Difference (IV, Fixed, 95% CI) Mean Difference (IV, Fixed, 95% CI) Mean Difference (IV, Fixed, 95% CI) Mean Difference (IV, Fixed, 95% CI) Mean Difference (IV, Fixed, 95% CI) Mean Difference (IV, Fixed, 95% CI) Mean Difference (IV, Fixed, 95% CI) Mean Difference (IV, Fixed, 95% CI) Mean Difference (IV, Fixed, 95% CI) Mean Difference (IV, Fixed, 95% CI) Mean Difference (IV, Fixed, 95% CI) Risk Ratio (M-H, Fixed, 95% CI) Risk Ratio (M-H, Fixed, 95% CI) Risk Ratio (M-H, Fixed, 95% CI) Risk Ratio (M-H, Fixed, 95% CI) Risk Ratio (M-H, Fixed, 95% CI) Risk Ratio (M-H, Fixed, 95% CI) Risk Ratio (M-H, Fixed, 95% CI) Risk Ratio (M-H, Fixed, 95% CI) Risk Ratio (M-H, Fixed, 95% CI) Risk Ratio (M-H, Fixed, 95% CI) Risk Ratio (M-H, Fixed, 95% CI) Risk Ratio (M-H, Fixed, 95% CI) Risk Ratio (M-H, Fixed, 95% CI) Risk Ratio (M-H, Fixed, 95% CI)
Not estimable Not estimable Not estimable Not estimable Totals not selected Not estimable Not estimable Not estimable Not estimable Not estimable Not estimable Totals not selected Not estimable Not estimable Not estimable Not estimable Not estimable Not estimable Subtotals only 0.20 [0.13, 0.32] 0.17 [0.09, 0.32] 1.64 [0.28, 9.44] 0.23 [0.01, 4.35] 12.02 [5.07, 28.49] 5.07 [1.34, 19.26] 3.25 [0.39, 27.00] 2.47 [0.10, 59.70] Not estimable 0.26 [0.05, 1.52] 1.52 [0.06, 36.34] 2.27 [0.23, 22.56] 0.50 [0.21, 1.15]
422 694 113 32 846 433 313 332 90 339 90 32 508
3 4 2
204 291 203
Risk Ratio (M-H, Fixed, 95% CI) Risk Ratio (M-H, Fixed, 95% CI) Risk Ratio (M-H, Fixed, 95% CI)
2.55 [0.98, 6.68] 7.71 [1.77, 33.54] 0.2 [0.01, 3.97]
48
17.17 Reex sympathetic dystrophy 17.18 Severe nger stiffness 17.19 Dupuytren contracture 17.20 Arthritis 17.21 Refracture 18 Reex sympathetic dystrophy exploratory analysis 18.1 Primary treatment 18.2 Redisplaced fractures 19 Cosmetic deformity 19.1 Cosmetic deformity (undened) 19.2 Prominent ulnar styloid 19.3 Radial deviation of hand 19.4 Residual dinner fork deformity 20 Patient dissatised with wrist 21 Anatomical grading: not excellent 22 Anatomical grading: fair or poor 23 Anatomical displacement 23.1 Loss in dorsal angulation (degrees) 23.2 Loss in radial angulation (degrees) 23.3 Loss in radial length (radial shortening) (mm) at around 1 year follow up 23.4 Loss in radial length (radial shortening) (mm) at 7 years follow up 23.5 Loss in dorsal displacement (mm) 23.6 Loss in radial displacement (mm) 24 Anatomical measurements 24.1 Dorsal angulation (degrees) at 13 weeks to 13 months follow up 24.2 Dorsal angulation (degrees) at 7 years follow up 24.3 Radial angulation (degrees) 24.4 Ulnar variance (mm) 25 Structural deformity 25.1 Malunion (as dened by trialist) 25.2 Malunion at 7 years follow up
11 1 1 2 1 11 9 2 2 1 1 1 1 1 5 6 5 0 1 4
731 61 32 121 35
Risk Ratio (M-H, Fixed, 95% CI) Risk Ratio (M-H, Fixed, 95% CI) Risk Ratio (M-H, Fixed, 95% CI) Risk Ratio (M-H, Fixed, 95% CI) Risk Ratio (M-H, Fixed, 95% CI) Risk Ratio (M-H, Fixed, 95% CI) Risk Ratio (M-H, Fixed, 95% CI) Risk Ratio (M-H, Fixed, 95% CI) Risk Ratio (M-H, Fixed, 95% CI) Risk Ratio (M-H, Fixed, 95% CI) Risk Ratio (M-H, Fixed, 95% CI) Risk Ratio (M-H, Fixed, 95% CI) Risk Ratio (M-H, Fixed, 95% CI) Risk Ratio (M-H, Fixed, 95% CI) Risk Ratio (M-H, Fixed, 95% CI) Risk Ratio (M-H, Fixed, 95% CI) Mean Difference (IV, Random, 95% CI) Mean Difference (IV, Random, 95% CI) Mean Difference (IV, Random, 95% CI) Mean Difference (IV, Random, 95% CI)
1.31 [0.74, 2.32] 0.13 [0.01, 2.32] 5.63 [0.29, 108.63] 0.73 [0.40, 1.34] 2.84 [0.12, 65.34] Subtotals only 1.03 [0.53, 1.98] 2.67 [0.75, 9.47] Totals not selected Not estimable Not estimable Not estimable Not estimable Totals not selected 0.53 [0.45, 0.61] 0.17 [0.11, 0.27] Totals not selected Not estimable Not estimable Not estimable
598 133
371 400
Mean Difference (IV, Random, 95% CI)
Not estimable
1 1 6 6
Mean Difference (IV, Random, 95% CI) Mean Difference (IV, Random, 95% CI) Mean Difference (IV, Fixed, 95% CI) Mean Difference (IV, Fixed, 95% CI)
Not estimable Not estimable Totals not selected Not estimable
1 1 1 6 2 1
Mean Difference (IV, Fixed, 95% CI) Mean Difference (IV, Fixed, 95% CI) Mean Difference (IV, Fixed, 95% CI) Risk Ratio (M-H, Fixed, 95% CI) Risk Ratio (M-H, Fixed, 95% CI) Risk Ratio (M-H, Fixed, 95% CI)
Not estimable Not estimable Not estimable Subtotals only 0.58 [0.41, 0.81] 0.96 [0.63, 1.47]
198 86
49
25.3 Carpal collapse 25.4 Dorsal tilt increase due to late collapse 25.5 Volar angulation of distal fragment 25.6 Step-off >/= 2 mm (intra-articular alignment) 25.7 Loss in position postimmobilisation 25.8 Non-congruous joint surface for die-punch fractures
1 1 1 1 1 1
90 41 41 32 50 31
Risk Ratio (M-H, Fixed, 95% CI) Risk Ratio (M-H, Fixed, 95% CI) Risk Ratio (M-H, Fixed, 95% CI) Risk Ratio (M-H, Fixed, 95% CI) Risk Ratio (M-H, Fixed, 95% CI) Risk Ratio (M-H, Fixed, 95% CI)
0.89 [0.55, 1.45] 0.64 [0.23, 1.79] 1.28 [0.29, 5.59] 5.63 [0.29, 108.63] 0.14 [0.01, 2.63] 0.48 [0.24, 0.97]
Analysis 1.1. Comparison 1 External xation versus plaster cast, Outcome 1 Functional grading: not excellent.
Review: External xation versus conservative treatment for distal radial fractures in adults
Comparison: 1 External xation versus plaster cast Outcome: 1 Functional grading: not excellent
Study or subgroup
External xation n/N
Plaster cast n/N 16/25 16/24 11/17 8/13 41/56 21/23 23/35 9/22 21/50
Risk Ratio M-H,Fixed,95% CI
Weight
Howard 1989 Abbaszadegan 1990 Hegeman 2004 Horne 1990 Jenkins 1989 Kapoor 2000 Rodriguez-Merchan 92 Roumen 1991 Young 2003
9/25 10/22 8/15 9/16 43/68 12/18 17/35 14/21 12/36
9.8 % 9.4 % 6.3 % 5.4 % 27.5 % 11.3 % 14.1 % 5.4 % 10.8 %
0.56 [ 0.31, 1.02 ] 0.68 [ 0.40, 1.17 ] 0.82 [ 0.46, 1.49 ] 0.91 [ 0.50, 1.68 ] 0.86 [ 0.68, 1.10 ] 0.73 [ 0.51, 1.04 ] 0.74 [ 0.49, 1.12 ] 1.63 [ 0.91, 2.93 ] 0.79 [ 0.45, 1.40 ]
Total (95% CI)
256
265
100.0 %
0.82 [ 0.71, 0.95 ]
Total events: 134 (External xation), 166 (Plaster cast) Heterogeneity: Chi2 = 8.21, df = 8 (P = 0.41); I2 =3% Test for overall effect: Z = 2.66 (P = 0.0079)
0.1 0.2
0.5
10
Favours xation
Favours plaster cast
50
Analysis 1.2. Comparison 1 External xation versus plaster cast, Outcome 2 Functional grading: not excellent. Worst and best case scenarios sensitivity analyses.
Comparison: 1 External xation versus plaster cast Outcome: 2 Functional grading: not excellent. Worst and best case scenarios sensitivity analyses
Study or subgroup
External xation n/N
Plaster cast n/N
Weight
1 Sensitivity analysis 1: worst case for plaster cast Howard 1989 Abbaszadegan 1990 Hegeman 2004 Horne 1990 Jenkins 1989 Kapoor 2000 Rodriguez-Merchan 92 Roumen 1991 Young 2003 9/25 10/23 8/15 9/16 43/84 12/28 17/35 14/21 12/59 16/25 16/24 11/17 8/13 54/69 31/33 23/35 9/22 37/66 7.8 % 7.6 % 5.0 % 4.3 % 28.9 % 13.9 % 11.2 % 4.3 % 17.0 % 0.56 [ 0.31, 1.02 ] 0.65 [ 0.38, 1.12 ] 0.82 [ 0.46, 1.49 ] 0.91 [ 0.50, 1.68 ] 0.65 [ 0.51, 0.83 ] 0.46 [ 0.29, 0.71 ] 0.74 [ 0.49, 1.12 ] 1.63 [ 0.91, 2.93 ] 0.36 [ 0.21, 0.63 ]
Subtotal (95% CI)
306
304
100.0 %
0.64 [ 0.55, 0.74 ]
Total events: 134 (External xation), 205 (Plaster cast) Heterogeneity: Chi2 = 18.87, df = 8 (P = 0.02); I2 =58% Test for overall effect: Z = 5.82 (P < 0.00001) 2 Sensitivity analysis 2: best case for plaster cast Howard 1989 Abbaszadegan 1990 Hegeman 2004 Horne 1990 Jenkins 1989 Kapoor 2000 Rodriguez-Merchan 92 Roumen 1991 Young 2003 9/25 11/23 8/15 9/16 59/84 22/28 17/35 14/21 35/59 16/25 16/24 11/17 8/13 41/69 21/33 23/35 9/22 21/66 9.6 % 9.4 % 6.2 % 5.3 % 27.0 % 11.6 % 13.8 % 5.3 % 11.9 % 0.56 [ 0.31, 1.02 ] 0.72 [ 0.43, 1.20 ] 0.82 [ 0.46, 1.49 ] 0.91 [ 0.50, 1.68 ] 1.18 [ 0.93, 1.50 ] 1.23 [ 0.89, 1.70 ] 0.74 [ 0.49, 1.12 ] 1.63 [ 0.91, 2.93 ] 1.86 [ 1.24, 2.81 ]
Subtotal (95% CI)
306
304
100.0 %
1.09 [ 0.95, 1.25 ]
0.1 0.2
0.5
10
Favours xation
51
Analysis 1.3. Comparison 1 External xation versus plaster cast, Outcome 3 Functional grading: fair or poor.
Comparison: 1 External xation versus plaster cast Outcome: 3 Functional grading: fair or poor
Study or subgroup
External xation n/N
Plaster cast n/N 9/24 3/17 3/13 7/25 12/56 13/23 15/35 3/22 6/22 3/50 9/17
Weight
Abbaszadegan 1990 Hegeman 2004 Horne 1990 Howard 1989 Jenkins 1989 Kapoor 2000 Rodriguez-Merchan 92 Roumen 1991 Stein 1990 Young 2003 Zheng 2003
3/22 2/15 5/16 6/25 18/68 4/18 7/35 9/21 4/40 2/36 2/12
10.5 % 3.4 % 4.0 % 8.5 % 16.1 % 13.9 % 18.3 % 3.6 % 9.4 % 3.1 % 9.1 %
0.36 [ 0.11, 1.17 ] 0.76 [ 0.15, 3.93 ] 1.35 [ 0.40, 4.63 ] 0.86 [ 0.34, 2.19 ] 1.24 [ 0.65, 2.34 ] 0.39 [ 0.15, 1.00 ] 0.47 [ 0.22, 1.00 ] 3.14 [ 0.98, 10.04 ] 0.37 [ 0.12, 1.16 ] 0.93 [ 0.16, 5.26 ] 0.31 [ 0.08, 1.20 ]
Total (95% CI)
308
304
100.0 %
0.73 [ 0.55, 0.98 ]
0.1 0.2
0.5
10
Favours xation
52
Analysis 1.4. Comparison 1 External xation versus plaster cast, Outcome 4 Subjective and objective functional evaluation.
Comparison: 1 External xation versus plaster cast Outcome: 4 Subjective and objective functional evaluation
Study or subgroup
External xation n/N
Plaster cast n/N
1 Subjective grading: not excellent Jenkins 1989 2 Subjective grading: fair/poor Jenkins 1989 Stein 1990 3 Objective grading: not excellent Jenkins 1989 4 Objective grading: fair/poor Jenkins 1989 Stein 1990 2/68 4/40 2/56 7/22 0.82 [ 0.12, 5.66 ] 0.31 [ 0.10, 0.96 ] 16/68 18/56 0.73 [ 0.41, 1.30 ] 18/68 4/40 12/56 6/22 1.24 [ 0.65, 2.34 ] 0.37 [ 0.12, 1.16 ] 43/68 41/56 0.86 [ 0.68, 1.10 ]
0.01
0.1
10
100
Favours xation
53
Analysis 1.5. Comparison 1 External xation versus plaster cast, Outcome 5 Upper extremity function part of Musculoskeletal Function Assessment tool (0 to 100: maximum disability).
Comparison: 1 External xation versus plaster cast Outcome: 5 Upper extremity function part of Musculoskeletal Function Assessment tool (0 to 100: maximum disability)
Study or subgroup
External xation N Mean(SD)
Plaster cast N Mean(SD)
Mean Difference IV,Fixed,95% CI
1 At 6 months Kreder 2006 2 At 1 year Kreder 2006 3 At 2 years Kreder 2006 44 12.7 (22.9) 41 15.6 (23.9) -2.90 [ -12.87, 7.07 ] 46 8.6 (14.9) 48 12.2 (18.2) -3.60 [ -10.31, 3.11 ] 51 15.8 (20) 57 22.4 (25.6) -6.60 [ -15.22, 2.02 ]
-100
-50
50
100
Favours xation
54
Analysis 1.6. Comparison 1 External xation versus plaster cast, Outcome 6 Difculties in activities of daily living.
Comparison: 1 External xation versus plaster cast Outcome: 6 Difculties in activities of daily living
Study or subgroup
External xation n/N
Plaster cast n/N
1 Lifting cup at 3 months Hegeman 2004 2 Lifting cup at 1 year Hegeman 2004 3 Hand wringing at 3 months Hegeman 2004 4 Hand wringing at 1 year Hegeman 2004 5 Fine hand co-ordination at 3 months Hegeman 2004 6 Fine hand co-ordination at 1 year Hegeman 2004 7 Heavy load bearing at 3 months Hegeman 2004 8 Heavy load bearing at 1 year Hegeman 2004 9 Difculty in turning keys or taps at 7 years Young 2003 4/36 4/50 1.39 [ 0.37, 5.19 ] 9/15 10/17 1.02 [ 0.57, 1.81 ] 12/15 13/17 1.05 [ 0.73, 1.51 ] 2/15 5/17 0.45 [ 0.10, 2.00 ] 10/15 3/17 3.78 [ 1.27, 11.21 ] 8/15 3/17 3.02 [ 0.98, 9.36 ] 13/15 11/17 1.34 [ 0.89, 2.00 ] 1/15 2/17 0.57 [ 0.06, 5.64 ] 8/15 3/17 3.02 [ 0.98, 9.36 ]
10 Difculty in picking up small objects and turning door handles at 7 years Young 2003 5/36 9/50 0.77 [ 0.28, 2.11 ]
0.01
0.1
10
100
Favours xation
55
Analysis 1.7. Comparison 1 External xation versus plaster cast, Outcome 7 Job change because of injury.
Comparison: 1 External xation versus plaster cast Outcome: 7 Job change because of injury
Study or subgroup
External xation n/N
Plaster cast n/N
1 At 6 months Kreder 2006 2 At 1 year Kreder 2006 3 At 2 years Kreder 2006 1/44 2/41 0.47 [ 0.04, 4.95 ] 1/46 4/48 0.26 [ 0.03, 2.25 ] 12/51 11/57 1.22 [ 0.59, 2.52 ]
0.01
0.1
10
100
Favours xation
Analysis 1.8. Comparison 1 External xation versus plaster cast, Outcome 8 Mass grip strength (% of normal side).
Comparison: 1 External xation versus plaster cast Outcome: 8 Mass grip strength (% of normal side)
Study or subgroup
Mean Difference IV,Random,95% CI
1 Results at around 1 year Hegeman 2004 Jenkins 1989 McQueen 1996 Young 2003 2 Results at 7 years follow up Young 2003 36 96 (30) 50 99 (30) -3.00 [ -15.85, 9.85 ] 15 68 54 48 71 (32) 93.88 (9.4) 59.19 (29.51) 86 (14) 17 56 28 60 78 (19) 86.65 (19.6) 68 (28) 73 (9) -7.00 [ -25.54, 11.54 ] 7.23 [ 1.63, 12.83 ] -8.81 [ -21.83, 4.21 ] 13.00 [ 8.43, 17.57 ]
-100
-50
50
100
Favours xation
56
Analysis 1.9. Comparison 1 External xation versus plaster cast, Outcome 9 Grip, chuck and pinch strengths (injured - normal side): units not given.
Comparison: 1 External xation versus plaster cast Outcome: 9 Grip, chuck and pinch strengths (injured - normal side): units not given
Study or subgroup
1 Grip strength at 2 years Kreder 2006 2 Chuck strength at 2 years Kreder 2006 3 Pinch strength at 2 years Kreder 2006 44 0.4 (2.5) 41 0.23 (1.8) 0.17 [ -0.75, 1.09 ] 44 -0.38 (1.5) 41 0.17 (1.9) -0.55 [ -1.28, 0.18 ] 44 -1.5 (8.7) 41 -4.7 (7) 3.20 [ -0.15, 6.55 ]
-10
-5
10
Favours xation
Analysis 1.10. Comparison 1 External xation versus plaster cast, Outcome 10 Maximal voluntary contraction: injured - uninjured side (Newtons).
Comparison: 1 External xation versus plaster cast Outcome: 10 Maximal voluntary contraction: injured - uninjured side (Newtons)
Study or subgroup
1 Results at 18 weeks Lagerstrom 1999 2 Results at 2 years Lagerstrom 1999 11 21.3 (48.9) 15 24.93 (42.95) -3.63 [ -39.79, 32.53 ] 11 86.9 (50.1) 15 84.67 (48.33) 2.23 [ -36.17, 40.63 ]
-100
-50
50
100
Favours xation
57
Analysis 1.11. Comparison 1 External xation versus plaster cast, Outcome 11 Persistent pain (1 year & 7 years).
Comparison: 1 External xation versus plaster cast Outcome: 11 Persistent pain (1 year % 7 years)
Study or subgroup
External xation n/N
Plaster cast n/N
1 At 1 year Young 2003 2 Radiocarpal pain at 1 year Hegeman 2004 3 Ulnocarpal pain at 1 year Hegeman 2004 4 Radioulnar pain at 1 year Hegeman 2004 5 At 7 years Young 2003 6/36 11/50 0.76 [ 0.31, 1.86 ] 2/15 3/17 0.76 [ 0.15, 3.93 ] 2/15 3/17 0.76 [ 0.15, 3.93 ] 2/15 3/17 0.76 [ 0.15, 3.93 ] 5/48 4/60 1.56 [ 0.44, 5.50 ]
0.01
0.1
10
100
Favours xation
Analysis 1.12. Comparison 1 External xation versus plaster cast, Outcome 12 Pain (6 months).
Comparison: 1 External xation versus plaster cast Outcome: 12 Pain (6 months)
Study or subgroup
External xation n/N
Plaster cast n/N
1 Pain at rest Roumen 1991 2 Pain on movement Roumen 1991 3 Ulnar compression pain Roumen 1991 6/21 3/22 2.10 [ 0.60, 7.32 ] 2/21 4/22 0.52 [ 0.11, 2.56 ] 1/21 0/22 3.14 [ 0.13, 72.96 ]
0.01
0.1
10
100
Favours xation
58
Analysis 1.13. Comparison 1 External xation versus plaster cast, Outcome 13 Range of movement at 1 year (% of normal side).
Comparison: 1 External xation versus plaster cast Outcome: 13 Range of movement at 1 year (% of normal side)
Study or subgroup
1 Flexion Hegeman 2004 Jenkins 1989 2 Extension Hegeman 2004 Jenkins 1989 3 Radial deviation Jenkins 1989 4 Ulnar deviation Jenkins 1989 5 Supination Jenkins 1989 6 Pronation Jenkins 1989 7 Flexion/extension McQueen 1996 8 Overall range of movement McQueen 1996 54 89 (13) 28 93 (11) -4.00 [ -9.35, 1.35 ] 54 86.56 (11.65) 28 83 (14) 3.56 [ -2.49, 9.61 ] 68 97.48 (10.02) 56 96.62 (8.63) 0.86 [ -2.42, 4.14 ] 68 95.88 (9.45) 56 98.77 (7.98) -2.89 [ -5.96, 0.18 ] 68 90.58 (15.33) 56 93.69 (14.57) -3.11 [ -8.39, 2.17 ] 68 92.13 (15.77) 56 95.12 (12.28) -2.99 [ -7.93, 1.95 ] 15 68 88 (20) 94.29 (12.06) 17 56 72 (21) 95.54 (11.24) 16.00 [ 1.78, 30.22 ] -1.25 [ -5.36, 2.86 ] 15 68 89 (19) 87.83 (14.79) 17 56 89 (17) 89.65 (13.09) 0.0 [ -12.56, 12.56 ] -1.82 [ -6.73, 3.09 ]
-100
-50
50
100
Favours xation
59
Analysis 1.14. Comparison 1 External xation versus plaster cast, Outcome 14 Range of movement at 2 years (injured - normal side).
Comparison: 1 External xation versus plaster cast Outcome: 14 Range of movement at 2 years (injured - normal side)
Study or subgroup
1 Flexion (degrees) Kreder 2006 2 Extension (degrees) Kreder 2006 3 Radial deviation (degrees) Kreder 2006 4 Ulnar deviation (degrees) Kreder 2006 5 Supination (degrees) Kreder 2006 6 Pronation (degrees) Kreder 2006 44 -4.6 (20.5) 41 -3.9 (7.8) -0.70 [ -7.21, 5.81 ] 44 -7.5 (14.2) 41 -1.1 (13.9) -6.40 [ -12.38, -0.42 ] 44 -3 (6.6) 41 -6 (12.4) 3.00 [ -1.27, 7.27 ] 44 0 (5.9) 41 -3.5 (8.8) 3.50 [ 0.29, 6.71 ] 44 -4.6 (8.9) 41 -6.2 (7.1) 1.60 [ -1.81, 5.01 ] 44 -8.9 (8.3) 41 -14.5 (15.2) 5.60 [ 0.34, 10.86 ]
-100
-50
50
100
Favours xation
60
Analysis 1.15. Comparison 1 External xation versus plaster cast, Outcome 15 Range of movement at 1 year.
Comparison: 1 External xation versus plaster cast Outcome: 15 Range of movement at 1 year
Study or subgroup
1 Flexion (degrees) Young 2003 2 Extension (degrees) Young 2003 3 Radial deviation (degrees) Young 2003 4 Ulnar deviation (degrees) Young 2003 5 Supination (degrees) Young 2003 6 Pronation (degrees) Young 2003 48 90 (0.6) 60 88 (0.2) 2.00 [ 1.82, 2.18 ] 48 87 (5) 60 86 (4) 1.00 [ -0.74, 2.74 ] 48 36 (4) 60 33 (5) 3.00 [ 1.30, 4.70 ] 48 21 (3.1) 60 22 (4.3) -1.00 [ -2.40, 0.40 ] 48 60 (5.7) 60 60 (7.1) 0.0 [ -2.41, 2.41 ] 48 63 (5.3) 60 61 (5.8) 2.00 [ -0.10, 4.10 ]
-10
-5
10
Favours xation
61
Analysis 1.16. Comparison 1 External xation versus plaster cast, Outcome 16 Range of movement at 7 years.
Comparison: 1 External xation versus plaster cast Outcome: 16 Range of movement at 7 years
Study or subgroup
1 Flexion (degrees) Young 2003 2 Extension (degrees) Young 2003 3 Radial deviation (degrees) Young 2003 4 Ulnar deviation (degrees) Young 2003 5 Supination (degrees) Young 2003 6 Pronation (degrees) Young 2003 36 88 (8) 50 87 (11) 1.00 [ -3.02, 5.02 ] 36 86 (7) 50 87 (8) -1.00 [ -4.19, 2.19 ] 36 41 (11) 50 40 (8) 1.00 [ -3.22, 5.22 ] 36 21 (9) 50 22 (8) -1.00 [ -4.68, 2.68 ] 36 65 (17) 50 71 (11) -6.00 [ -12.34, 0.34 ] 36 60 (13) 50 57 (12) 3.00 [ -2.39, 8.39 ]
-10
-5
10
Favours xation
62
Analysis 1.17. Comparison 1 External xation versus plaster cast, Outcome 17 Complications.
Comparison: 1 External xation versus plaster cast Outcome: 17 Complications
Study or subgroup
External xation n/N
Plaster cast n/N
1 Redisplacement /recurrent instability McQueen 1996 Pring 1988 Rodriguez-Merchan 92 Stein 1990 Young 2003 14/60 0/36 0/35 3/40 4/59 16/30 9/39 27/35 16/22 5/66 0.44 [ 0.25, 0.77 ] 0.06 [ 0.00, 0.94 ] 0.02 [ 0.00, 0.29 ] 0.10 [ 0.03, 0.32 ] 0.89 [ 0.25, 3.18 ]
Subtotal (95% CI)
230
192
0.20 [ 0.13, 0.32 ]
Total events: 21 (External xation), 73 (Plaster cast) Heterogeneity: Chi2 = 17.65, df = 4 (P = 0.001); I2 =77% Test for overall effect: Z = 6.86 (P < 0.00001) 2 Redisplacement resulting in secondary treatment Abbaszadegan 1990 Horne 1990 Howard 1989 Jenkins 1989 Kreder 2006 Lagerstrom 1999 Pring 1988 Stein 1990 Young 2003 0/23 0/17 3/25 0/84 1/54 0/18 0/36 0/40 3/59 5/24 0/17 9/25 4/69 5/59 5/17 9/39 11/22 3/66 0.09 [ 0.01, 1.62 ] 0.0 [ 0.0, 0.0 ] 0.33 [ 0.10, 1.09 ] 0.09 [ 0.01, 1.67 ] 0.22 [ 0.03, 1.81 ] 0.09 [ 0.01, 1.45 ] 0.06 [ 0.00, 0.94 ] 0.02 [ 0.00, 0.40 ] 1.12 [ 0.23, 5.33 ]
Subtotal (95% CI)

Total events: 7 (External xation), 51 (Plaster cast)
356
338
0.17 [ 0.09, 0.32 ]
Heterogeneity: Chi2 = 9.94, df = 7 (P = 0.19); I2 =30% Test for overall effect: Z = 5.41 (P < 0.00001) 3 Distal radial ulnar joint instability Kreder 2006 3/54 2/59 1.64 [ 0.28, 9.44 ]
Subtotal (95% CI)

Total events: 3 (External xation), 2 (Plaster cast) Heterogeneity: not applicable Test for overall effect: Z = 0.55 (P = 0.58)
54
59
1.64 [ 0.28, 9.44 ]
0.001 0.01 0.1 Favours xation
10 100 1000 Favours plaster cast
(Continued . . . )
63
(. . .
Study or subgroup External xation n/N 4 Plaster cast problems (swollen thumb; loose plaster) Hegeman 2004 0/15 2/17 Plaster cast n/N Risk Ratio M-H,Fixed,95% CI
Continued) Risk Ratio
M-H,Fixed,95% CI
0.23 [ 0.01, 4.35 ]
Subtotal (95% CI)

Total events: 0 (External xation), 2 (Plaster cast) Heterogeneity: not applicable Test for overall effect: Z = 0.99 (P = 0.32) 5 Pin track infection Abbaszadegan 1990 Hegeman 2004 Howard 1989 Jenkins 1989 Kapoor 2000 Kreder 2006 McQueen 1996 Rodriguez-Merchan 92 Roumen 1991 Stein 1990 Young 2003
15
17
0.23 [ 0.01, 4.35 ]
3/23 2/15 2/25 26/84 1/28 6/54 9/60 4/35 0/21 2/40 14/59
0/24 0/17 0/25 0/69 0/33 1/59 0/30 0/35 0/22 0/22 0/66
7.29 [ 0.40, 133.82 ] 5.63 [ 0.29, 108.63 ] 5.00 [ 0.25, 99.16 ] 43.65 [ 2.71, 703.47 ] 3.52 [ 0.15, 83.07 ] 6.56 [ 0.82, 52.71 ] 9.66 [ 0.58, 160.50 ] 9.00 [ 0.50, 161.13 ] 0.0 [ 0.0, 0.0 ] 2.80 [ 0.14, 55.95 ] 32.38 [ 1.97, 531.25 ]
Subtotal (95% CI)

444
402
12.02 [ 5.07, 28.49 ]
Heterogeneity: Chi2 = 3.88, df = 9 (P = 0.92); I2 =0.0% Test for overall effect: Z = 5.65 (P < 0.00001) 6 Pin loosening and other pin site problems Abbaszadegan 1990 Horne 1990 Jenkins 1989 Rodriguez-Merchan 92 Roumen 1991 Stein 1990 Zheng 2003 0/23 3/15 1/84 3/35 2/21 0/40 1/12 0/24 0/14 0/69 0/35 0/22 0/22 0/17 0.0 [ 0.0, 0.0 ] 6.56 [ 0.37, 116.70 ] 2.47 [ 0.10, 59.70 ] 7.00 [ 0.37, 130.69 ] 5.23 [ 0.27, 102.87 ] 0.0 [ 0.0, 0.0 ] 4.15 [ 0.18, 94.08 ]
Subtotal (95% CI)

230
203
5.07 [ 1.34, 19.26 ]
Heterogeneity: Chi2 = 0.29, df = 4 (P = 0.99); I2 =0.0% Test for overall effect: Z = 2.38 (P = 0.017) 7 Premature frame/xator removal Jenkins 1989 2/84 0/69
0.001 0.01 0.1 Favours xation 1 10 100 1000 Favours plaster cast
4.12 [ 0.20, 84.36 ]
(Continued . . . )
64
(. . .
Study or subgroup External xation n/N McQueen 1996 Rodriguez-Merchan 92 2/60 0/35 Plaster cast n/N 0/30 0/35 Risk Ratio M-H,Fixed,95% CI
M-H,Fixed,95% CI 2.54 [ 0.13, 51.31 ] 0.0 [ 0.0, 0.0 ]
Subtotal (95% CI)

179
134
3.25 [ 0.39, 27.00 ]
Heterogeneity: Chi2 = 0.05, df = 1 (P = 0.82); I2 =0.0% Test for overall effect: Z = 1.09 (P = 0.27) 8 Osteomyelitis Abbaszadegan 1990 Jenkins 1989 Rodriguez-Merchan 92 Stein 1990 0/23 1/84 0/35 0/40 0/24 0/69 0/35 0/22 0.0 [ 0.0, 0.0 ] 2.47 [ 0.10, 59.70 ] 0.0 [ 0.0, 0.0 ] 0.0 [ 0.0, 0.0 ]
Subtotal (95% CI)

182
150
2.47 [ 0.10, 59.70 ]
Heterogeneity: Chi2 = 0.0, df = 0 (P = 1.00); I2 =0.0% Test for overall effect: Z = 0.56 (P = 0.58) 9 Wound infection McQueen 1996 0/60 0/30 0.0 [ 0.0, 0.0 ]
Subtotal (95% CI)

Total events: 0 (External xation), 0 (Plaster cast) Heterogeneity: not applicable Test for overall effect: Z = 0.0 (P < 0.00001) 10 Tendon injury/rupture Howard 1989 McQueen 1996 Rodriguez-Merchan 92 Roumen 1991 Young 2003
60
30
0.0 [ 0.0, 0.0 ]
0/25 0/60 0/35 0/21 0/36
1/25 0/30 0/35 2/22 2/50
0.33 [ 0.01, 7.81 ] 0.0 [ 0.0, 0.0 ] 0.0 [ 0.0, 0.0 ] 0.21 [ 0.01, 4.11 ] 0.28 [ 0.01, 5.57 ]
Subtotal (95% CI)

177
162
0.26 [ 0.05, 1.52 ]
Heterogeneity: Chi2 = 0.05, df = 2 (P = 0.98); I2 =0.0% Test for overall effect: Z = 1.49 (P = 0.14) 11 Dorsal medial neuropraxia McQueen 1996 1/60 0/30 1.52 [ 0.06, 36.34 ]
Subtotal (95% CI)

Total events: 1 (External xation), 0 (Plaster cast) Heterogeneity: not applicable Test for overall effect: Z = 0.26 (P = 0.79) 12 Transient neuropraxia
60
30
1.52 [ 0.06, 36.34 ]
(Continued . . . )
(. . .
Study or subgroup External xation n/N Hegeman 2004 2/15 Plaster cast n/N 1/17 Risk Ratio M-H,Fixed,95% CI
M-H,Fixed,95% CI 2.27 [ 0.23, 22.56 ]
Subtotal (95% CI)

15
17
2.27 [ 0.23, 22.56 ]
13 Median nerve compression /Carpal tunnel syndrome Howard 1989 Jenkins 1989 Kapoor 2000 McQueen 1996 Young 2003 Zheng 2003 0/25 0/84 0/28 3/60 4/59 0/12 4/25 0/69 1/33 1/30 6/66 3/17 0.11 [ 0.01, 1.96 ] 0.0 [ 0.0, 0.0 ] 0.39 [ 0.02, 9.23 ] 1.50 [ 0.16, 13.82 ] 0.75 [ 0.22, 2.51 ] 0.20 [ 0.01, 3.51 ]
Subtotal (95% CI)

268
240
0.50 [ 0.21, 1.15 ]
Heterogeneity: Chi2 = 2.84, df = 4 (P = 0.58); I2 =0.0% Test for overall effect: Z = 1.63 (P = 0.10) 14 Radial nerve neuritis or neuropathy Horne 1990 Howard 1989 Young 2003 4/15 1/25 8/59 0/14 3/25 2/66 8.44 [ 0.50, 143.77 ] 0.33 [ 0.04, 2.99 ] 4.47 [ 0.99, 20.24 ]
Subtotal (95% CI)

99
105
2.55 [ 0.98, 6.68 ]
Heterogeneity: Chi2 = 4.52, df = 2 (P = 0.10); I2 =56% Test for overall effect: Z = 1.91 (P = 0.056) 15 Supercial radial nerve paraesthesia or injury Abbaszadegan 1990 Jenkins 1989 Stein 1990 Zheng 2003 1/23 11/84 3/40 1/12 0/24 0/69 0/22 0/17 3.13 [ 0.13, 73.01 ] 18.94 [ 1.14, 315.78 ] 3.93 [ 0.21, 72.73 ] 4.15 [ 0.18, 94.08 ]
Subtotal (95% CI)

159
132
7.71 [ 1.77, 33.54 ]
Heterogeneity: Chi2 = 1.06, df = 3 (P = 0.79); I2 =0.0% Test for overall effect: Z = 2.72 (P = 0.0065) 16 Ulnar nerve compression Howard 1989 Jenkins 1989 0/25 0/84 2/25 0/69
0.20 [ 0.01, 3.97 ] 0.0 [ 0.0, 0.0 ]
(Continued . . . )
66
(. . .
Study or subgroup External xation n/N Plaster cast n/N Risk Ratio M-H,Fixed,95% CI
M-H,Fixed,95% CI
Subtotal (95% CI)

109
94
0.20 [ 0.01, 3.97 ]
Heterogeneity: Chi2 = 0.0, df = 0 (P = 1.00); I2 =0.0% Test for overall effect: Z = 1.06 (P = 0.29) 17 Reex sympathetic dystrophy Hegeman 2004 Horne 1990 Howard 1989 Jenkins 1989 Kapoor 2000 Kreder 2006 McQueen 1996 Rodriguez-Merchan 92 Roumen 1991 Stein 1990 Young 2003 4/15 0/15 0/25 0/32 1/28 1/54 7/60 0/35 4/21 1/40 7/59 1/17 0/14 0/25 2/24 0/33 2/59 1/30 2/35 2/22 0/22 7/66 4.53 [ 0.57, 36.23 ] 0.0 [ 0.0, 0.0 ] 0.0 [ 0.0, 0.0 ] 0.15 [ 0.01, 3.02 ] 3.52 [ 0.15, 83.07 ] 0.55 [ 0.05, 5.86 ] 3.50 [ 0.45, 27.16 ] 0.20 [ 0.01, 4.02 ] 2.10 [ 0.43, 10.26 ] 1.68 [ 0.07, 39.65 ] 1.12 [ 0.42, 3.00 ]
Subtotal (95% CI)
384
347
1.31 [ 0.74, 2.32 ]
Total events: 25 (External xation), 17 (Plaster cast) Heterogeneity: Chi2 = 7.11, df = 8 (P = 0.52); I2 =0.0% Test for overall effect: Z = 0.91 (P = 0.36) 18 Severe nger stiffness Kapoor 2000 0/28 4/33 0.13 [ 0.01, 2.32 ]
Subtotal (95% CI)

Total events: 0 (External xation), 4 (Plaster cast) Heterogeneity: not applicable Test for overall effect: Z = 1.39 (P = 0.17) 19 Dupuytren contracture Hegeman 2004
28
33
0.13 [ 0.01, 2.32 ]
2/15
0/17
5.63 [ 0.29, 108.63 ]
Subtotal (95% CI)

Total events: 2 (External xation), 0 (Plaster cast) Heterogeneity: not applicable Test for overall effect: Z = 1.14 (P = 0.25) 20 Arthritis Howard 1989 Young 2003
15
17
5.63 [ 0.29, 108.63 ]
8/19 1/36
11/16 0/50
0.61 [ 0.33, 1.14 ] 4.14 [ 0.17, 98.69 ]
Subtotal (95% CI)

55
66
0.73 [ 0.40, 1.34 ]
(Continued . . . )
(. . .
Study or subgroup External xation n/N Heterogeneity: Chi2 = 1.46, df = 1 (P = 0.23); I2 =32% Test for overall effect: Z = 1.01 (P = 0.31) 21 Refracture Lagerstrom 1999 1/18 0/17 Plaster cast n/N Risk Ratio M-H,Fixed,95% CI
M-H,Fixed,95% CI
2.84 [ 0.12, 65.34 ]
Subtotal (95% CI)

18
17
2.84 [ 0.12, 65.34 ]
Analysis 1.18. Comparison 1 External xation versus plaster cast, Outcome 18 Reex sympathetic dystrophy - exploratory analysis.
Comparison: 1 External xation versus plaster cast Outcome: 18 Reex sympathetic dystrophy - exploratory analysis
Study or subgroup
External xation n/N
Plaster cast n/N
1 Primary treatment Hegeman 2004 Horne 1990 Howard 1989 Jenkins 1989 Kapoor 2000 Kreder 2006 Rodriguez-Merchan 92 Stein 1990 Young 2003 4/15 0/15 0/25 0/32 1/28 1/54 0/35 1/40 7/59 1/17 0/14 0/25 2/24 0/33 2/59 2/35 0/22 7/66 4.53 [ 0.57, 36.23 ] 0.0 [ 0.0, 0.0 ] 0.0 [ 0.0, 0.0 ] 0.15 [ 0.01, 3.02 ] 3.52 [ 0.15, 83.07 ] 0.55 [ 0.05, 5.86 ] 0.20 [ 0.01, 4.02 ] 1.68 [ 0.07, 39.65 ] 1.12 [ 0.42, 3.00 ]
Subtotal (95% CI)
303
295
1.03 [ 0.53, 1.98 ]
Total events: 14 (External xation), 14 (Plaster cast) Heterogeneity: Chi2 = 5.65, df = 6 (P = 0.46); I2 =0.0%
0.01
0.1
10
100
Favours xation
(Continued . . . )
68
(. . .
Study or subgroup External xation n/N Test for overall effect: Z = 0.08 (P = 0.94) 2 Redisplaced fractures McQueen 1996 Roumen 1991 7/60 4/21 1/30 2/22 Plaster cast n/N Risk Ratio M-H,Fixed,95% CI
M-H,Fixed,95% CI
3.50 [ 0.45, 27.16 ] 2.10 [ 0.43, 10.26 ]
Subtotal (95% CI)

81
52
2.67 [ 0.75, 9.47 ]
Heterogeneity: Chi2 = 0.16, df = 1 (P = 0.69); I2 =0.0% Test for overall effect: Z = 1.52 (P = 0.13)
0.01
0.1
10
100
Favours xation
Analysis 1.19. Comparison 1 External xation versus plaster cast, Outcome 19 Cosmetic deformity.
Comparison: 1 External xation versus plaster cast Outcome: 19 Cosmetic deformity
Study or subgroup
External xation n/N
Plaster cast n/N
1 Cosmetic deformity (undened) Kapoor 2000 2 Prominent ulnar styloid Hegeman 2004 3 Radial deviation of hand Hegeman 2004 4 Residual dinner fork deformity Hegeman 2004 0/15 1/17 0.38 [ 0.02, 8.57 ] 2/15 3/17 0.76 [ 0.15, 3.93 ] 7/15 12/17 0.66 [ 0.35, 1.23 ] 2/18 0/23 6.32 [ 0.32, 123.86 ]
69
Analysis 1.20. Comparison 1 External xation versus plaster cast, Outcome 20 Patient dissatised with wrist.
Comparison: 1 External xation versus plaster cast Outcome: 20 Patient dissatised with wrist
Study or subgroup
External xation n/N
Plaster cast n/N 4/50
Risk Ratio M-H,Fixed,95% CI 0.69 [ 0.13, 3.59 ]
Young 2003
2/36
0.1 0.2
0.5
10
Favours xation
Analysis 1.21. Comparison 1 External xation versus plaster cast, Outcome 21 Anatomical grading: not excellent.
Comparison: 1 External xation versus plaster cast Outcome: 21 Anatomical grading: not excellent
Study or subgroup
External xation n/N
Plaster cast n/N 23/25 62/65 22/35 22/22 19/22
Weight
Howard 1989 Jenkins 1989 Rodriguez-Merchan 92 Roumen 1991 Stein 1990
11/25 42/81 16/35 14/21 7/40
14.3 % 42.9 % 13.7 % 13.7 % 15.3 %
0.48 [ 0.30, 0.76 ] 0.54 [ 0.44, 0.68 ] 0.73 [ 0.47, 1.13 ] 0.67 [ 0.50, 0.92 ] 0.20 [ 0.10, 0.41 ]
Total (95% CI)
202
169
100.0 %
0.53 [ 0.45, 0.61 ]
Total events: 90 (External xation), 148 (Plaster cast) Heterogeneity: Chi2 = 12.13, df = 4 (P = 0.02); I2 =67% Test for overall effect: Z = 8.06 (P < 0.00001)
0.1 0.2
0.5
10
Favours xation
70
Analysis 1.22. Comparison 1 External xation versus plaster cast, Outcome 22 Anatomical grading: fair or poor.
Comparison: 1 External xation versus plaster cast Outcome: 22 Anatomical grading: fair or poor
Study or subgroup
External xation n/N
Plaster cast n/N 6/25 36/65 16/35 22/22 9/22 7/17
Weight
Howard 1989 Jenkins 1989 Rodriguez-Merchan 92 Roumen 1991 Stein 1990 Zheng 2003
2/25 5/81 4/35 5/21 0/40 1/12
5.9 % 39.2 % 15.7 % 21.6 % 11.9 % 5.7 %
0.33 [ 0.07, 1.50 ] 0.11 [ 0.05, 0.27 ] 0.25 [ 0.09, 0.67 ] 0.26 [ 0.12, 0.53 ] 0.03 [ 0.00, 0.48 ] 0.20 [ 0.03, 1.44 ]
Total (95% CI)
214
186
100.0 %
0.17 [ 0.11, 0.27 ]
Total events: 17 (External xation), 96 (Plaster cast) Heterogeneity: Chi2 = 4.90, df = 5 (P = 0.43); I2 =0.0% Test for overall effect: Z = 7.77 (P < 0.00001)
0.01
0.1
10
100
Favours xation
71
Analysis 1.23. Comparison 1 External xation versus plaster cast, Outcome 23 Anatomical displacement.
Comparison: 1 External xation versus plaster cast Outcome: 23 Anatomical displacement
Study or subgroup
1 Loss in dorsal angulation (degrees) 2 Loss in radial angulation (degrees) Jenkins 1989 81 2.4 (5.04) 65 6.97 (7.49) -4.57 [ -6.70, -2.44 ]
3 Loss in radial length (radial shortening) (mm) at around 1 year follow up Jenkins 1989 McQueen 1996 Young 2003 Zheng 2003 81 54 48 12 0.73 (2.67) 2.52 (2.57) 0.9 (0.5) 1.01 (0.76) 65 28 60 17 4 (4.28) 2 (3) 1.6 (1) 5.11 (1.96) -3.27 [ -4.46, -2.08 ] 0.52 [ -0.79, 1.83 ] -0.70 [ -0.99, -0.41 ] -4.10 [ -5.13, -3.07 ]
4 Loss in radial length (radial shortening) (mm) at 7 years follow up Young 2003 5 Loss in dorsal displacement (mm) Horne 1990 6 Loss in radial displacement (mm) Horne 1990 15 1.67 (2.19) 14 2.64 (2.5) -0.97 [ -2.69, 0.75 ] 15 3.13 (2.1) 14 2.29 (2.81) 0.84 [ -0.98, 2.66 ] 36 1.5 (2) 50 2 (2) -0.50 [ -1.36, 0.36 ]
-10
-5
10
Favours xation
72
Analysis 1.24. Comparison 1 External xation versus plaster cast, Outcome 24 Anatomical measurements.
Comparison: 1 External xation versus plaster cast Outcome: 24 Anatomical measurements Study or subgroup External xation N Mean(SD) Plaster cast N Mean(SD) Mean Difference IV,Fixed,95% CI Mean Difference IV,Fixed,95% CI
1 Dorsal angulation (degrees) at 13 weeks to 13 months follow up Hegeman 2004 Howard 1989 Jenkins 1989 McQueen 1996 Young 2003 Zheng 2003 15 25 81 54 48 12 2.9 (11) 11.5 (8.7) -6.73 (9.35) 6.44 (12.65) -0.7 (2.5) 1 (8.8) 17 25 65 28 60 17 12.7 (14.6) 17.3 (10.6) 7.87 (12.49) 13 (11) 3.9 (3.5) 10.12 (11.1) -9.80 [ -18.70, -0.90 ] -5.80 [ -11.18, -0.42 ] -14.60 [ -18.26, -10.94 ] -6.56 [ -11.85, -1.27 ] -4.60 [ -5.73, -3.47 ] -9.12 [ -16.37, -1.87 ]
2 Dorsal angulation (degrees) at 7 years follow up Young 2003 3 Radial angulation (degrees) Hegeman 2004 4 Ulnar variance (mm) Hegeman 2004 15 3.3 (5.3) 17 2.2 (2.6) 1.10 [ -1.85, 4.05 ] 15 22.7 (4.9) 17 17.5 (7.8) 5.20 [ 0.74, 9.66 ] 36 4 (9) 50 3 (10) 1.00 [ -3.04, 5.04 ]
-100
-50
50
100
Not applicable
Not applicable
73
Analysis 1.25. Comparison 1 External xation versus plaster cast, Outcome 25 Structural deformity.
Comparison: 1 External xation versus plaster cast Outcome: 25 Structural deformity
Study or subgroup
External xation n/N
Plaster cast n/N
Weight
1 Malunion (as dened by trialist) McQueen 1996 Young 2003 24/60 12/48 20/30 27/60 52.6 % 47.4 % 0.60 [ 0.40, 0.90 ] 0.56 [ 0.32, 0.98 ]
Subtotal (95% CI)
108
90
100.0 %
0.58 [ 0.41, 0.81 ]
Total events: 36 (External xation), 47 (Plaster cast) Heterogeneity: Chi2 = 0.05, df = 1 (P = 0.82); I2 =0.0% Test for overall effect: Z = 3.17 (P = 0.0015) 2 Malunion at 7 years follow up Young 2003 18/36 26/50 100.0 % 0.96 [ 0.63, 1.47 ]
Subtotal (95% CI)

Heterogeneity: not applicable Test for overall effect: Z = 0.18 (P = 0.86) 3 Carpal collapse McQueen 1996
36
50
100.0 %
0.96 [ 0.63, 1.47 ]
25/60
14/30
100.0 %
0.89 [ 0.55, 1.45 ]
Subtotal (95% CI)

Heterogeneity: not applicable Test for overall effect: Z = 0.46 (P = 0.65) 4 Dorsal tilt increase due to late collapse Kapoor 2000
60
30
100.0 %
0.89 [ 0.55, 1.45 ]
4/18
8/23
100.0 %
0.64 [ 0.23, 1.79 ]
Subtotal (95% CI)

Heterogeneity: not applicable Test for overall effect: Z = 0.85 (P = 0.39) 5 Volar angulation of distal fragment Kapoor 2000
18
23
100.0 %
0.64 [ 0.23, 1.79 ]
3/18
3/23
100.0 %
1.28 [ 0.29, 5.59 ]
Subtotal (95% CI)

Heterogeneity: not applicable Test for overall effect: Z = 0.33 (P = 0.74)
18
23
100.0 %
1.28 [ 0.29, 5.59 ]
6 Step-off >/= 2 mm (intra-articular alignment) Hegeman 2004 2/15 0/17

100.0 %
5.63 [ 0.29, 108.63 ]
(Continued . . . )
74
(. . .
Study or subgroup External xation n/N Plaster cast n/N Risk Ratio M-H,Fixed,95% CI Weight
M-H,Fixed,95% CI
Subtotal (95% CI)

Heterogeneity: not applicable Test for overall effect: Z = 1.14 (P = 0.25) 7 Loss in position post-immobilisation Howard 1989
15
17
100.0 %
5.63 [ 0.29, 108.63 ]
0/25
3/25
100.0 %
0.14 [ 0.01, 2.63 ]
Subtotal (95% CI)

25
25
100.0 %
0.14 [ 0.01, 2.63 ]
8 Non-congruous joint surface for die-punch fractures Jenkins 1989 7/20 8/11 100.0 % 0.48 [ 0.24, 0.97 ]
Subtotal (95% CI)

20
11
100.0 %
0.48 [ 0.24, 0.97 ]
APPENDICES Appendix 1. Search strategy The Cochrane Library (Wiley InterScience)

#1 MeSH descriptor Radius Fractures explode all trees in MeSH products #2 MeSH descriptor Wrist Injuries explode all trees in MeSH products #3 (#1 OR #2) #4 ((distal near radius) or (distal near radial)) in Title, Abstract or Keywords in all products #5 (colles or smith or smiths) in Title, Abstract or Keywords in all products #6 wrist* in Title, Abstract or Keywords in all products #7 (#4 OR #5 OR #6) #8 fractur* in Title, Abstract or Keywords in all products #9 (#7 AND #8) #10 (#3 OR #9)
Appendix 2. Search strategy for MEDLINE (OVID-WEB)

1. exp Radius Fractures/ 2. Wrist Injuries/ 3. (((distal adj3 (radius or radial)) or wrist or colles or smith$2) adj3 fracture$).ti,ab. 4. or/1-3
75
Appendix 3. Search strategies for CINAHL and EMBASE (OVID-WEB)
CINAHL 1. Radius Fractures/ 2. Wrist Injuries/ 3. or/1-2 4. (((distal adj3 (radius or radial)) or wrist or colles or smith$2) adj3 fracture$).ti,ab. 5. or/3-4 6. exp Clinical Trials/ 7. exp Evaluation Research/ 8. exp Comparative Studies/ 9. exp Crossover Design/ 10. clinical trial.pt. 11. or/6-10 12. ((clinical or controlled or comparative or placebo or prospective or randomi#ed) adj3 (trial or study)).tw. 13. (random$ adj7 (allocat$ or allot$ or assign$ or basis$ or divid$ or order$)).tw. 14. ((singl$ or doubl$ or trebl$ or tripl$) adj7 (blind$ or mask$) ).tw. 15. (cross?over$ or (cross adj1 over$)).tw. 16. ((allocat$ or allot$ or assign$ or divid$) adj3 (condition$ or experiment$ or intervention$ or treatment$ or therap$ or control$ or group$)).tw. 17. or/12-16 18. or/11,17 19. and/5,18
EMBASE 1. (((distal adj3 (radius or radial)) or wrist or colles$2 or smith$2) adj3 fracture$).tw. 2. Colles Fracture/ or Radius Fracture/ or Wrist Fracture/ or Wrist Injury/ 3. or/1-2 4. exp Randomized Controlled trial/ 5. exp Double Blind Procedure/ 6. exp Single Blind Procedure/ 7. exp Crossover Procedure/ 8. or/4-8 9. ((clinical or controlled or comparative or placebo or prospective$ or randomi#ed) adj3 (trial or study)).tw. 10. (random$ adj7 (allocat$ or allot$ or assign$ or basis$ or divid$ or order$)).tw. 11. ((singl$ or doubl$ or trebl$ or tripl$) adj7 (blind$ or mask$) ).tw. 12. (cross?over$ or (cross adj1 over$)).tw. 13. ((allocat$ or allot$ or assign$ or divid$) adj3 (condition$ or experiment$ or intervention$ or treatment$ or therap$ or control$ or group$)).tw. 14. or/9-13 15. or/8,14 16. Animal/ not Human/ 17. 15 not 16 18. and/3,17
FEEDBACK Inclusion of pins and plaster external xation

Summary Comment from Mr David L Shaw (04.12.07): The authors are to be congratulated on this extensive review of a common problem in current trauma practice. The validity of their conclusions are let down however by a glaring error in the abstract. The use of pin and plaster as a form of external xation was only ever routinely applied to unstable tibial fractures or possibly in third world or battleeld situations. The mechanical construct which one can achieve with wires or screws inserted into the bone and then wrapped in plaster is in no way comparable to the use of a device specically designed to stabilise a distal radial fracture. In relation to the choice between fracture xation and manipulation, only one of the most relevant questions relates to the risks of redisplacement and the benet of remanipulation as opposed to defaulting to operative stabilisation if fracture reduction has been lost at some time after manipulation has been used as the primary treatment.
Reply We thank Mr Shaw for his interest in our review and for his feedback.
Cochrane reviews are intended for a world-wide audience. It is thus appropriate that lower-cost methods such as pins and plaster are considered. Although its results were consistent with the review conclusions, the actual contribution of quantitative evidence from the only trial testing pins and plaster external xation to the review and the conclusions was minimal. Mr Shaw may be interested to read our review on Different methods of external xation for treating distal radial fractures in adults, which includes a comparison of external xation versus pins and plaster xation. Our conclusion of unknown effectiveness for this comparison reects the inadequate evidence from two trials available to address this comparison but it is still notable that the evidence from neither trial condemned the use of plaster and pins xation. We agree there is a distinction between primary and secondary (upon redisplacement) xation and consider in our review that both situations represent fracture instability. Contributors Comment from Mr David L Shaw (04.12.07) Response from HHG Handoll and WJ Gillespie (18.12.07)
WHATS NEW
Last assessed as up-to-date: 16 May 2007.
9 May 2008
Amended
Converted to new review format.
HISTORY
Protocol rst published: Issue 4, 2006 Review rst published: Issue 3, 2007
CONTRIBUTIONS OF AUTHORS
This review was initiated by Helen Handoll (HH) who prepared the rst draft of the protocol. This was critically reviewed by the other two authors, Rajan Madhok (RM) and Jim Huntley (JH). HH searched for trials and contacted trial authors. All three authors performed study selection. HH and JH reviewed those trials that had not been included in a previous review covering all surgical interventions. HH repeated her review of the other included trials that had been quality assessed previously by RM and HH. HH completed the rst draft of the review in RevMan. All versions were scrutinised by the other two authors. Helen Handoll is the guarantor of the review.
77
DECLARATIONS OF INTEREST
None known.
SOURCES OF SUPPORT Internal sources

University of Teesside, Middlesbrough, UK.
External sources
No sources of support supplied
NOTES
Some of the wording in each of several sections of this review (in particular: Synopsis, Background, Methods, Discussion and Implications) is taken either entirely or in only a slightly modied form from a related review on Percutaneous pinning for distal radial fractures in adults. This has been done to make the review self-contained and to ensure consistency between related reviews without requiring unnecessary cross-referring by readers.
INDEX TERMS Medical Subject Headings (MeSH)

Casts, Surgical; Bone Nails; Colles Fracture [surgery]; Fracture Fixation [ methods]; Radius Fractures [ surgery; therapy]; Randomized
Controlled Trials as Topic; Wrist Injuries [surgery; therapy]
MeSH check words

Adult; Aged; Female; Humans; Male; Middle Aged
78

CD 006194

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CD 006194

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External xation versus conservative treatment for distal radial fractures in adults (Review)

Handoll HHG, Huntley JS, Madhok R

DECLARATIONS OF INTEREST SOURCES OF SUPPORT . . . NOTES . . . . . . . . . . INDEX TERMS . . . . . .

Criteria for considering studies for this review

Table 1. Denitions of key radiological parameters

(4) Resource use

Search methods for identication of studies

Data collection and analysis

Table 2. Methodological quality assessment scheme

Table 2. Methodological quality assessment scheme

Table 3. Categories of effectiveness (denitions)

Trade off between benets and harms

Likely to be ineffective or harmful

RESULTS Description of studies

Table 4. Key characteristics of participants, fractures and interventions

Table 4. Key characteristics of participants, fractures and interventions

Participants gender, age)

(N, Fracture Type/Clas- Timing of surgery/ Fixation sication Reduction

Closed reduction and below elbow plaster cast for 6 weeks

Table 4. Key characteristics of participants, fractures and interventions

Not stated, but acute injury treatment. No details of reduction method.

Not stated, but probably acute. No details of reduction method.

Table 4. Key characteristics of participants, fractures and interventions

Table 4. Key characteristics of participants, fractures and interventions

Risk of bias in included studies

McQueen 1996 Pring 1988

Young 2003 Zheng 2003

Table 6. Category of effectiveness for external xation versus conservative treatment

AUTHORS CONCLUSIONS Implications for practice

Implications for research

References to studies included in this review

References to studies excluded from this review

References to studies awaiting assessment

CHARACTERISTICS OF STUDIES Characteristics of included studies [ordered by study ID]

Risk of bias Item Authors judgement Description

Allocation concealment? Howard 1989 Methods

Risk of bias Item Authors judgement Description

Allocation concealment? Jenkins 1989 Methods

Risk of bias Item Allocation concealment? Authors judgement No Description C - Inadequate

Authors judgement Unclear

Authors judgement Unclear

Authors judgement Unclear

Notes Risk of bias

Item Allocation concealment? Roumen 1991 Methods

Authors judgement Unclear

Notes Risk of bias Item Allocation concealment?

Authors judgement Unclear

Risk of bias Item Allocation concealment? Authors judgement No Description C - Inadequate

Risk of bias Item Authors judgement Description

Allocation concealment? Zheng 2003 Methods

Notes Risk of bias Item Allocation concealment?

Characteristics of excluded studies [ordered by study ID]

Kongsholm 1989 Solgaard 1989

van Dijk 1996

DATA AND ANALYSES

Comparison 1. External xation versus plaster cast

No. of participants 521

Effect size 0.82 [0.71, 0.95] Subtotals only

610 610 612

Not estimable Not estimable

Not estimable Not estimable Not estimable Totals not selected

422 694 113 32 846 433 313 332 90 339 90 32 508

204 291 203

2.55 [0.98, 6.68] 7.71 [1.77, 33.54] 0.2 [0.01, 3.97]