Failure of transfemoral osseointegrated prostheses

Nick Badger 18 October 2012

Badger BACKGROUND AND INTRODUCTION

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There are 1.7 million amputees in the United States today. Lower extremity amputations are roughly four times more common than upper extremity amputations, and of these transtibial amputations are slightly more common than transfemoral amputations, with occurrence rates of approximately 40,000 and 35,000 patients per year, respectively. Lower extremity amputations are caused predominantly by disease (70%), followed by trauma (22%), birth defects (4%), and osseosarcomas (4%). Patients outfitted with traditional socket prostheses report particularly high incidence of discomfort, pain, sores, rashes, and sweating at the socket site, as well as difficulty donning and doffing the prosthesis. Socket prostheses are also associated with retention difficulties on the limbs themselves, and the socket chassis component constitutes a major portion of modern prosthesis design. Overall, 97% of patients believe their socket negatively affects their quality of life [9]. Direct skeletal attachment has long been pursued as a viable means of replacing the socket with a more natural, biologically-integrated and inspired prosthesis interface. Early attempts at bone anchorage were made via cementation of the implant to the bone, but these were plagued by low mechanical strength, chronic loosening, and sometimes avulsion and outright rejection. With the discovery of osseointegration in 1952, direct skeletal attachment of implants was finally made viable, with the first dental prostheses arriving in clinical applications in 1965. The process gained popularity in the 1980s and the first osseointegrated long-bone structural prostheses were attempted in the 1990s [5]. Osseointegrated prostheses have seen a broad range of clinical relevance, including maxillofacial reconstruction implants; digit prostheses; transfemoral, transhumeral, transtibial, and transradial amputee prostheses; and particularly in dental reconstruction. Prostheses for transfemoral amputees have been of particular interest to researchers due to the increased potential for an improved quality of life and the relative ease of access to the comparatively large medullary cavity of a transfemoral amputee. They have, however, been plagued by clinical complications and suboptimal patient success rates. STATE OF THE ART Currently researchers in three countries have pursued osseointegrated prostheses for transfemoral amputees: The Centre of Orthopaedic Osseointegration in Gtheberg, Sweden; the Clinic for Plastic, Hand, and Reconstructive Surgery in Lbeck, Germany; and the Institute of Orthopaedics and Musculo-Skeletal Science in London, UK. The Swedish device, known by the acronym OPRA (Osseointegration of Prostheses for the Rehabilitation of Amputees), has seen the longest clinical use, followed by the German implant, known by the moniker EEFP (EndoExo femoral prosthesis). Though OPRA has seen some adoption in the United Kingdom, their unique approach, termed ITAP (Intraosseus Transcutaneous Amputation Prostheses), saw its first human clinical use in a patient that suffered a traumatic transhumeral amputation as a result of

Failure of transfemoral osseointegrated prostheses

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the 2005 London train bombing. The first 18 patients implanted with transfemoral ITAP prostheses form the only current clinical trial of the device. The OPRA prosthesis was developed based on experience accumulated from several decades of osseointegrated oral implants and bears a great resemblance to its predecessor. It is composed of an osseointegrated fixture, which is initially implanted Figure 1: OPRA device [5] and allowed a 6-month minimum period of unloaded rest, and an abutment screw, which is easily replaceable and interfaces directly with both the external prosthesis and internal implant. It serves as an engineered point of failure and is intended to bend or break even in relatively mild overload conditions to protect the integrity of the femur and the implant. The external prosthesis also contains a torsion overload protector, as all osseointegrated implants suffer from torsional weakness. Of 91 patients with transfemoral amputations in a total of 97 limbs, 20 implants were removed, 13 of which were replaced by a second implant. Occasional abutment replacement was relatively common, but overall satisfaction with the implants was good. OPRA implant failures (with the exception of abutment replacement) were primarily due to implant loosening. This resulted in severe pain and an inability to use the external prosthesis; in most cases this was followed by implant removal and potentially replacement. Radiographs have indicated considerable perioprosthetic bone loss and osteoporosity, but no complications have been reported as a result of this skeletal weakness. Abutments were replaced as a result of falls and overloading, mechanical wear, and non-specific breakage. OPRA patients also reported infections at the percutaneous interface, sometimes severe, which in more than one instance also resulted in the permanent removal of the implant [10]. In most cases, however, problems in the transcutaneous region were Figure 2: Periprosthetic bone reduction in OPRA case study [13] minor, superficial, and managed with oral antibiotics. OPRA implants are also prone to some level of tissue ingrowth surrounding the abutment; this has been termed marsupialism. The EEFP built upon the foundations of the OPRA and investigated the incorporation of porous titanium to promote osseointegration. EEFP implants are significantly longer than OPRA implants but utilize a similar two-part system. The abutment, however, has lost its function as an engineered point of failure. Due to the relatively new nature of both the EEFP and the ITAP, no

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longitudinal data are available with any statistically significant patient base. EEFP implants follow a similar (though accelerated) rehabilitation schedule to the OPRA implants and do not appear to suffer from the loosening issue. The larger EEFP exhibits pronounced bone periprosthetic bone degredation, and this has been manifested in a high rate of post-implantation periprosthetic femoral fracture. The EEFP can be interfaced with traditional titanium hardware with some difficulty, and existing femoral implant systems have been used to Figure 3: Periprosthetic femoral fracture and clinical stabilization thereof [1] correct such fractures, which typically occur at the proximal tip of the implant. The abutment does not experience the mechanical failure modes of the OPRA. The EEFP suffers from potentially worse complications at the transcutaneous region: the risk of both deep- and superficial infection is still present and at least one case study was presented in which the distal titanium mesh had been avulsed through the skin of the stump (though this was corrected with a skin graft). The principle progressive focus in ITAP development was improving the percutaneous interface through biomimetic strategies. The British team successfully and significantly reduced the risk of infection and tissue ingrowth, even to the point that the first ITAP recipient has expressed no difficulty, discomfort, or infection following swimming in public pools. The ITAP implant also incorporates axial cutting flutes to aid in torsional stabilization, but is a single-part implant and hence lacks an engineered point of failure. It is similar in size to the OPRA implant. Unfortunately this implant is so new that Figure 4: The ITAP implant system [6] no data are as of yet available on periprosthetic bone loss or postimplantation fracture risks.

Failure of transfemoral osseointegrated prostheses

18 October 2012

Badger FAILURE ANALYSIS

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OPRA implant loosening failures are rather poorly understood. It was found that adequate rest and rehabilitation periods substantially decreased incidence of loosening, and invivo rat models have suggested that this may be the result of the slow onset of osseointegration [2]. They have also indicated that torsional instability may indicate that the process of osseointegration is not as complete as previously thought. Though patients implanted with the OPRA prosthesis do not typically exhibit related femoral fractures, the notable weakening of the surrounding bone has been a cause of significant concern. Though non-severe, abutment failure is certainly a patient hindrance, and increased abutment strength is difficult to implement without compromising its utility as the primary implant failure point. The inherent protection provided to the implant by the weak abutment has likely been the single most important factor in limiting post-implantation femoral fracture. This is compounded by the significant difficulty in predicting femoral loading in patients with osseointegrated prostheses [7]. Transcutaneous failure of the OPRA and EEFP implants is perhaps their best-understood failure mode. Permeation of infections along perforations of the protective skin barrier have been thoroughly studied, and especially thanks to research into stomas and other percutaneous devices they have been relatively well-addressed. In addition to percutaneous microbial seepage around the implant itself, mechanical stresses in the skin around the abutment can promote both avulsion and ingrowth [4]. Without the protection of a disposable abutment, the EEFP prosthesis system has suffered from an ostensibly higher failure rate due to femoral fracture following implantation. In every reported case this has occurred near the proximal intramedullary tip of the implant and required significant reconstructive effort [8]. There is a significant stress raiser at this location, and the overall stresses in the remaining bone surrounding an osseointegrated prosthesis in has been demonstrated to be highly atypical of normal human load transfer. It has been theorized that the bone loss associated with osseointegrated prostheses can be attributed to the skeletal unloading and remodeling following implantation, which may also have resulted in several intertrochanter fractures reported in supposedly non-implant-related injuries [12]. Post-implantation bone weakening has been compounded by preexisting osseodegradation due to prolongued abnormal limb usage, whether through socket prostheses or non-mobility. Attempts to reduce stress shielding around the implant have focused on the substantial difference in elasticity between the bone and the implant. Preliminary clinical information suggests that this does in fact reduce periprosthetic bone loss, though there is insufficient data to draw a conclusion about its effectiveness in addressing long-term femoral strength [11]. Any potential difficulties with bone degradation notwithstanding, the ITAP implant likely presents the most comprehensive approach at a fully-biocompatible implant. Especially given

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the single-piece construction of the implant, however, the likelihood of periprosthetic fracture seems high. DISCUSSION Structural musculoskeletal osseointegrated prostheses are an emergent field. Particularly as a result of the poor scientific understanding of osseointegration, implants in the past have been plagued by unacceptable failure rates. Despite such frequent occurrence of undesirable implant outcomes, patients have typically been both quite capable and quite willing to pursue reimplantation, which bespeaks the drastically improved quality of life that many of these patients experience. The most successful osseointegrated implant in terms of patient care rendered has certainly been the OPRA device. It has the longest track record of any load-bearing osseointegrated implant, and after adopting adequate post-operative rest periods and incremental loading exercises for targeted rehabilitation it remains one of the most reliable. Pursuing new strategies for biocompatible percutaneous interfaces, similar to the ITAP device, is likely to result in a significantly more robust implant. Simultaneously, advances in materials technology, porous metal foams, and additive freeform metal manufacturing are making complex, geometryoptimized shapes more and more viable means of combating stress-shielding-induced bone loss. The progress and success of the OPRA program (and its contemporaries) is incredibly reassuring. Meanwhile, osseosarcoma-related limb salvage techniques have greatly benefited from research into osseointegration to the point where integrated implants are being developed with the capability to non-invasively expand with a growing juvenile limb. Osseointegration in many ways represents the most promising frontier of prosthesis development. On a quality of life scale developed specifically for transfemoral amputees, patients implanted with an OPRA device quite consistently reported (in a longitudinal study) significantly higher global scores post-implantation than they did with a socket prosthesis. Even those patients who underwent a complicated implant removal following an integration failure tended to opt for re-implantation which was, in turn, typically successful. With such an incredibly large number of amputees expressing decreased quality of life due to socket complications, the contemporary developments in osseointegration offer a promising perspective on future progress.

Failure of transfemoral osseointegrated prostheses

18 October 2012

Badger References

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[1] Aschoff HH, Clausen A, Tsoumpris K, Hoffmeister T. Implantation der Endo-ExoFemurprothese zur Verbesserung der Mobilitt amputierter Patienten [Implantation of the endo-exo femur prosthesis to improve the mobility of amputees]. Oper Orthop Traumatol. 2011;23(5):462-72. [2] Brnemark R, Ohrnell LO, Nilsson P, Thomsen P. Biomechanical characterization of osseointegration during healing: an experimental in vivo study in the rat. Biomaterials. 1997;18(14):969-78. [3] Cannon S., Pendegrass C., Kang N., Fitzpatrick N., Blunn G. Development of an intraosseous transcutaneous amputation prostheses (ITAP). J Bone Joint Surg Br 2012; 94-B:(SUPP XXI) 94. [4] Feldman DS, Von recum AF. Non-epidermally induced failure modes of percutaneous devices. Biomaterials. 1985;6(5):352-6. [5] Hagberg K, Brnemark R. One hundred patients treated with osseointegrated transfemoral amputation prostheses--rehabilitation perspective. J Rehabil Res Dev. 2009;46(3):331-44. [6] Kang NV, Pendegrass C, Marks L, Blunn G. Osseocutaneous integration of an intraosseous transcutaneous amputation prosthesis implant used for reconstruction of a transhumeral amputee: case report. J Hand Surg Am. 2010;35(7):1130-4. [7] Lee WC, Frossard LA, Hagberg K, et al. Magnitude and variability of loading on the osseointegrated implant of transfemoral amputees during walking. Med Eng Phys. 2008;30(7):825-33. [8] Lunow C, Staubach KH, Aschoff HH. Die Endo-Exo- Femurprothese Klinischer Verlauf nach Erstimplantation einer intramedullren, perkutan ausgeleiteten Femurprothese nach Oberschenkelamputation [Endo-exo femoral prosthesis: clinical course after primary implantation of an intramedullary percutaneous endo-exo femoral prosthesis following upper leg amputation]. Unfallchirurg. 2010;113(7):589-93. [9] Sullivan J, Uden M, Robinson KP, Sooriakumaran S. Rehabilitation of the trans-femoral amputee with an osseointegrated prosthesis: the United Kingdom experience. Prosthet Orthot Int. 2003;27(2):114-20. [10] Tillander J, Hagberg K, Hagberg L, Brnemark R. Osseointegrated titanium implants for limb prostheses attachments: infectious complications. Clin Orthop Relat Res. 2010;468(10):2781-8. [11] Tomaszewski PK, Van diest M, Bulstra SK, Verdonschot N, Verkerke GJ. Numerical analysis of an osseointegrated prosthesis fixation with reduced bone failure risk and periprosthetic bone loss. J Biomech. 2012;45(11):1875-80.

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[12] Tomaszewski PK, Verdonschot N, Bulstra SK, Verkerke GJ. A comparative finite-element analysis of bone failure and load transfer of osseointegrated prostheses fixations. Ann Biomed Eng. 2010;38(7):2418-27. [13] Xu W, Robinson K. X-ray image review of the bone remodeling around an osseointegrated trans-femoral implant and a finite element simulation case study. Ann Biomed Eng. 2008;36(3):435-43.

Failure of transfemoral osseointegrated prostheses

18 October 2012