Aims

Safety concerns surrounding osseointegration are a significant barrier to replacing socket prosthesis as the standard of care following limb amputation. While implanted osseointegrated prostheses traditionally occur in two stages, a one-stage approach has emerged. Currently, there is no existing comparison of the outcomes of these different approaches. To address safety concerns, this study sought to determine whether a one-stage osseointegration procedure is associated with fewer adverse events than the two-staged approach.

Aims

The aim of this study was to compare the cost-effectiveness of treatment with an osseointegrated percutaneous (OI-) prosthesis and a socket-suspended (S-) prosthesis for patients with a transfemoral amputation.

Aims. Prior cost-effectiveness analyses on osseointegrated prosthesis for transfemoral unilateral amputees have analyzed outcomes in non-USA countries using generic quality of life instruments, which may not be appropriate when evaluating disease-specific quality of life. These prior analyses have also focused only on patients who had failed a socket-based prosthesis. The aim of the current study is to use a disease-specific quality of life instrument, which can more accurately reflect a patient’s quality of life with this condition in order to evaluate cost-effectiveness, examining both treatment-naïve and socket refractory patients. Methods. Lifetime Markov models were developed evaluating active healthy middle-aged male amputees. Costs of the prostheses, associated complications, use/non-use, and annual costs of arthroplasty parts and service for both a socket and osseointegrated (OPRA) prosthesis were included. Effectiveness was evaluated using the questionnaire for persons with a transfemoral amputation (Q-TFA) until death. All costs and Q-TFA were discounted at 3% annually. Sensitivity analyses on those cost variables which affected a change in treatment (OPRA to socket, or socket to OPRA) were evaluated to determine threshold values. Incremental cost-effectiveness ratios (ICERs) were calculated. Results. For treatment-naïve patients, the lifetime ICER for OPRA was $279/quality-adjusted life-year (QALY). For treatment-refractory patients the ICER was $273/QALY. In sensitivity analysis, the variable thresholds that would affect a change in the course of treatment based on cost (from socket to OPRA), included the following for the treatment-naïve group: yearly replacement components for socket > $8,511; cost yearly replacement parts OPRA < $1,758; and for treatment-refractory group: yearly replacement component for socket of > $12,467. Conclusion. The use of the OPRA prosthesis in physically active transfemoral amputees should be considered as a cost-effective alternative in both treatment-naïve and treatment-refractory socket prosthesis patients. Disease-specific quality of life assessments such as Q-TFA are more sensitive when evaluating cost-effectiveness. Cite this article: Bone Jt Open 2024;5(3):218–226

Introduction. Osseointegration has been established as a promising approach for the reconstruction of amputated limbs, particularly for amputees suffering from traditional socket prosthesis (TSP). While Osseointegration was originally developed with a screw fixation design, several Osseointegration devices adopting a modern press-fit design have also been introduced. In this study, medium-term outcomes for patients with the two most common press-fit osseointegration implant used worldwide are analysed. Materials and Methods. This is a cross-sectional analysis containing a cohort of Osseointegration patients treated in several centres worldwide. We analyzed a total of 93 patients with an average follow-up time of 6.52 years. Functional, Mobility and patient reported outcomes were collected pre-operatively and during follow-up. All postoperative adverse events (infection, revision surgery, fractures, and implant failures) were also analyzed. Results. Crude analysis of the data indicated that all 93 patients continue to use their osseointegrated prosthesis. Significant improvements for all outcome measures were observed. However, several adverse events including 19 implant revisions, 8 periprosthetic fractures and 43 surgical debridements were also reported. A detailed analysis was performed on each adverse event type to evaluate possible causes. Conclusions. At 5 years post-surgery, Osseointegration continues to provide amputees with improvements on function and quality of life which were previously unattainable with socket prosthesis. However, the benefits are accompanied with a relatively high risk of adverse events. Further research in standardizing clinical practice and the development of better implant may offer a reduction to these risks

Aims

Osseointegrated prosthetic limbs allow better mobility than socket-mounted prosthetics for lower limb amputees. Fractures, however, can occur in the residual limb, but they have rarely been reported. Approximately 2% to 3% of amputees with socket-mounted prostheses may fracture within five years. This is the first study which directly addresses the risks and management of periprosthetic osseointegration fractures in amputees.