Introduction
This collection of abstracts from journal articles, scientific exhibits and additional reference materials has been brought
together using Medline, Embase and physical searches of available literature.
It is intended to list the references available relating to the Corail Hip System and to give a brief description of their
contents.
*
Full articles can be ordered within the Corail clinical folder (Cat No: 9072-74-000 version 2)
Table of Contents
Long Term Survivorship
Proven Features
Indication: Revision
12
Indication: Infection
13
14
15
Hallan G; Lie SA: Furnes O: Engesaeter LB; Vollset SE; Havelin LI*
Medium and long-term performance of 11,516 uncemented primary femoral stems from the Norwegian arthroplasty
register. Journal of Bone and Joint Surgery, 2007;89-B:1574-1580
Primary uncemented femoral stems reported to the Norwegian arthroplasty register between 1987 and 2005 were included in this
prospective observational study. There were 11,516 hips (9679 patients) and 14 different designs of stem. Kaplan-Meier survival
probabilities and Cox regression were used to analyse the data. With aseptic loosening as the end-point, all currently used designs
performed excellently with survival of 96% to 100% at ten years. With the end-point as stem revision for any cause, the long-term
results of the different designs varied from poor to excellent, with survival at 15 years ranging between 29% and 97%. Follow-up
for longer than seven years was needed to identify some of the poorly performing designs. There were differences between
the stems; the Corail used in 5456 hips, was the most frequently used stem with a survival of 97% at 15 years. Male gender
was associated with an increased risk of revision of X 1.3 (95% confidence interval 1.05 to 1.52), but age and diagnosis had no
influence on the results. Overall modern uncemented femoral stems performed well. Moderate differences in survival between
well-performing stems should be interpreted with caution since the differences may be caused by factors other than the stem
itself.
Boldt J
Femoral bone remodeling in HA coated stems with 20 years follow-up. Presented at EFORT Congress, May 29 June 2, 2008
Femoral stress shielding in cementless THA is a potential complication commonly observed in distally loading press-fit stems.
This prospective study describes long-term femoral bone remodeling in cementless THA at a mean of 17 years (range: 15 to 20)
in 208 consecutive fully HA-coated stems (Corail, DePuy Int. Ltd, Leeds, UK). All THA were performed by one group of surgeons
between 1986 and 1991. The concept of surgical technique included impaction of metaphyseal bone utilizing bland femoral
broaches until primary stability was achieved without distal press-fit. Radiographic evaluation revealed a total of five (2.4%) stems
with periprosthetic osteolysis, which were associated with eccentric polyethylene wear. They were either revised or awaiting revision
surgery. The remaining 97.6% stems revealed biologic load transfer in the metaphysis alone (52%) or in both metaphysis and
diaphysis (48%). Stem survival of 97.6% after 15 to 20 years without stress shielding were considered to be related to: impaction
of metaphyseal bone, bland broaches, HA coating, and unique prosthetic design.
Vidalain JP*
Corail Stem Long-Term Results Based upon the 15-Years ARTRO Group Experience. In: Epinette JA, Manley MT, editors.
Fifteen Years of Clinical Experience with Hydroxyapatite Coatings in Joint Arthroplasty. Paris: Springer; 2004;217-224
This study continues to demonstrate that the benefits of HA should not be confined to an early but temporary role. Bioactive
coatings may contribute to the durability and stability by significantly reducing osteolysis and the risk of delayed aseptic loosening.
In the short run, Hydroxyapatite improves clinical results significantly in providing superior stability thanks to osteointegration. In
the intermediate term, the mechanical characteristics of the implant will likely play a critical role, although it becomes more and
more evident that the quality of the load transfer is also dependant on the nature of the bone between the implant and the host
site. In addition, a full coating does not increase the rate of proximal bone resorption in so far as the shape of the stem prevents
distal blockages and harmonizes strain distribution on the bone with a progressive rigidity gradient. In the long run preservation of
the long-term stability and excellent bone trophicity will further increase the durability of the implant. Let us hope that the 98.3%
survival rate of the Corail femoral stem will be maintained during the next decade.
Full articles can be ordered within the Corail clinical folder (Cat No: 9072-74-000 version 2)
3
Proven Features
The papers in this section discuss the design features of the Corail stem such as the thin distal tip, full HA coating, primary
fixation, macro and micro structure and tissue and bone sparing design. Those features have proven to deliver superior long term
survivorship and clinical outcomes.
Proven Features
Reikeras O; Gunderson RB*
Excellent Results of HA Coating on a Grit-Blasted Stem, 245 Patients Followed for 8-12 Years. Acta Orthopedica
Scandinavica, 2003;74(2):140-145
We report the outcome of a grit-blasted titanium stem designed for press-fit insertion and entirely plasma sprayed with HA.
During the years 1988-1993, we performed 323 primary total hip replacements in 276 patients (189 women) with a HA-coated
prosthesis. Their mean age was 48 (15-79) years. During the follow-up, 12 patients died. 19 other patients did not attend the
follow-up examination, but had no major symptoms according to telephone interviews and written replies. Thus, 245 patients
(291 hips) were followed for a mean of 10 (8-12) years with radiographic and clinical examinations. Only 1 stem was revised
due to mechanical failure. None were revised because of infection. Osteolysis was significantly associated with wear, and wear
was significantly associated with the size of the femoral head. We found a small amount of proximal bone loss (37/291) and
a low incidence of distal hypertrophy of the bone (23/291). These observations indicate an essentially physiological weight
distribution from the stem to the femoral bone. The changes in the bone confirmed that the femoral component was well fixed in
asymptomatic patients. To conclude, we found excellent 8-12-year results with a fully HA-coated femoral prosthesis designed for
press-fit insertion.
Rkkum M; Reigstad A*
Total Hip Replacement With an Entirely Hydroxyapatite-Coated Prosthesis. 5 Years Follow-Up of 94 Consecutive Hips.
Journal of Arthroplasty, 1999;14(6):689-700
The first 100 consecutive entirely hydroxyapatite (HA)-coated hip arthroplasties in 86 patients (mean age, 56.2 years [range,
32-73 years]; female-to-male ratio, 75:25) were followed with standardized radiographs annually up to 5 years. All components
developed 100% intimate bone-implant contact, being gradually reduced to 99.5%+/-3.8% by 2 partial periacetabular lines and
on the femoral side to 94.0%+/-6.1% and 96.5%+/-5.2% in the frontal and lateral planes by lines along 75 stems, mostly in zones
1 and 8. Bone formation took place adjacent to the prostheses regularly, with gap filling and comprehensive periprosthetic bone
remodeling, stabilizing at 3 years. No adverse stress shielding was found. The clinical results were excellent without thigh pain. We
believe that all components were bonded directly to bone, promoted by the reliable primary fixation and the osteoconductive effect
of HA.
Full articles can be ordered within the Corail clinical folder (Cat No: 9072-74-000 version 2)
5
Hardy D; Frayssinet P*
Hydroxyapatite-Coated Femoral Arthroplasties : Long Term Study Through 29 Corail Prostheses Explanted During Ten
Year Survey. Surgical Technology International X, 2003;237-245
In our department, all the patients over 65 years of age with a displaced intracapsular fracture of the upper femur (type III and IV
of the Gardens Classification) are treated with a femoral hemiarthroplasty. This practice is relatively universal among the European
traumatologic centres. Two prospective and randomized trails, published in 2000, reported a high rate of reoperation when treating
these fractures with osteosynthesis (36% and 38% of the cases), thus indicating arthroplasty may be preferred.
Full articles can be ordered within the Corail clinical folder (Cat No: 9072-74-000 version 2)
7
Rogmark C; Johnell O*
Primary arthroplasty is better than internal fixation of displaced femoral neck fractures: a meta-analysis of 14
randomized studies with 2,289 patients. Acta Orthopaedica, 2006;77(3):359-367
The treatment of displaced femoral neck fractures has long been debated. 14 randomized controlled studies (RCTs) comparing
internal fixation with primary arthroplasty may give material for evidence-based decision-making. Methods computerized databases
were searched for RCTs published between 1966 and 2004. 14 RCTs containing 2,289 patients were included in a meta-analysis
regarding complications, re-operations and mortality. The analysis was performed with software from the Cochrane collaboration.
Results were concluded as primary arthroplasty leads to significantly fewer major method-related hip complications and
re-operations, compared to internal fixation. There was no significant difference in mortality between the two groups at 30 days
and 1 year. Most of the studies found better function and less pain after primary arthroplasty. Primary arthroplasty should be used
in most patients with displaced femoral neck fracture. The healthy, lucid individual, 7080 years old, should be given a total hip
arthroplasty. The older, impaired or institutionalized patient would benefit from a hemiarthroplasty.
Indication: Revision
The Corail Hip System has proven its reliability and durability in both primary and revision total hip arthroplasty. Due to a
combination of good design and full HA coatings, the Corail family offers the potential to restore good periprosthetic bone
trophicity, increase bone ingrowth and minimize stress shielding after a revision procedure.
Full articles can be ordered within the Corail clinical folder (Cat No: 9072-74-000 version 2)
9
Indication: Revision
Petit R
Hydroxyapatite and revision of femoral hip prostheses. European Journal of Orthopaedic Surgery and Traumatology
1999;9:107-110
Implants coated with Hydroxyapatite (HA) are of very special importance in revisions of total hip prostheses. As far as the femur
is concerned, the rapid bony reconstruction due to the osteoconductive properties, which ensure in particular the filling of defects
of bony contact guarantee excellent secondary stabilization of the implants, provided that the mechanical assembly secured at
operation be stable. The results of a personal series of 46 patients confirm the efficacy of the HA coating by demonstrating the
quality of bony reconstruction and the long-term stability of the implants with satisfactory clinical results.
Vidalain JP
Advantages of a modular interlocked HA coated stem in revisions with major bone deficiencies. Presented at the
International Society for Technology in Arthroplasty, October 1-3, 1998
This papers review a modular interlocked and osteoconductive device to treat cases of major femoral deficiencies encountered in
revision surgeries. 35 patients suffering from severe femoral loosening corresponding to grade 3B and grade 4 of the Paproskys
classification were included in the study. Patients were treated with the REEF prostheses which is a modular femoral component
made up of two parts: 1) The trochanteric component providing for the adjustment of neck length, anteversion and offset. 2) The
metaphyseo-diaphyseal stem has a proximal tapered portion with horizontal macrotextures, and a distal cylindrical and curved
portion with longitudinal grooves and two distal holes for interlocking screws. This study concludes that preliminary data on revision
surgery with a modular HA coated and interlocked long stem have demonstrated that once implants have acquired bony stability,
the prospect for long term prosthesis survival is very favorable. Restoration of good periprosthetic bone trophicity is a reality. If long
term bone status is improved, any future surgery will be easier indeed.
10
Indication: Revision
Hernndez-Vaquero D, Suarez-Vazquez A, Cima-Suarez M, Garcia-Sandoval MA, Gava R
Extensively hydroxyapatite-coated stems in revision hip arthroplasty: A radiological mid-term follow-up study.
Hip International, 2005;15:38-45
Femoral revision surgery involves the placement of a stable stem and the regeneration of the damaged bone structure. We
retrospectively reviewed 36 cases of femoral revision surgery in which an extensively hydroxyapatite-coated porous stem was
implanted with a five-year minimum follow-up. Nine of the cases had type I defects, 12 had type II defects, six had III-A defects and
nine had III-B defects. The mean follow-up was 7.7 years (range 5-11). No cases of revision surgery, subsidence or displacement
were detected. In 35 cases the integration of the stem had been achieved, the bone structure had been restored and there was no
fibrous interface visible between the implant and the bone. The fully hydroxyapatite-coated stems thus proved a valuable alternative
for femoral revision surgery in mild and moderate bone defects.
Full articles can be ordered within the Corail clinical folder (Cat No: 9072-74-000 version 2)
11
Vidalain JP*
Can we propose a HA-THR to a patient younger than 50 years old? Retrospective study of a continuous series of 131
Corail prostheses (mean follow up 5 years). Presented at the European Hip Society, June 25-27, 1998, Beaune, France
Long life expectancy, specific pathologies, hard professional activities and sometimes still practicing sport are the main
characteristics of a population needing hip arthroplasty before 50 years of age. This study concerns a continuous series of 131
Corail prosthesis implanted between 1987 and 1993, the mean follow up was 5.02 years (SD 3.08). The different demographic
data concerning the patients were as follows: male 48%: mean age 42.1 years, the main aetiologies were: AON 30%: dysplasia
27%: primary arthrosis 23%: secondary arthrosis 12% and arthritis 5%. The quality of clinical results confirmed that we can really
propose HA coated implants to young patients needing THR. The survivorship rate of both components was identical to those
of the best cemented prosthesis at the time. The global F.U. is short, but the absence of specific complications, and of aseptic
loosening was noted. In addition, the biological junction, bone/implant, seemed to reduce PE debris migration.
12
Indication: Infection
Corail can also be utilised for infection in revision cases.
Full articles can be ordered within the Corail clinical folder (Cat No: 9072-74-000 version 2)
13
14
Full articles can be ordered within the Corail clinical folder (Cat No: 9072-74-000 version 2)
15
16
Issued: 08/09
0459
0086