Background: There is renewed interest in total ankle arthroplasty as an alternative to ankle fusion in the treatment of end-stage ankle arthritis. Despite a lack of long-term data on the clinical outcomes associated with these implants, the use of ankle arthroplasty is expanding. The purpose of this cost-effectiveness analysis was to evaluate whether the currently available literature justifies the emerging use of total ankle arthroplasty. This study also identifies thresholds for the durability and function of ankle prostheses that, if met, would support more widespread dissemination of this new technology.

Methods: A decision model was created for the treatment of ankle arthritis. The literature was reviewed to identify possible outcomes and their probabilities following ankle fusion and ankle arthroplasty. Each outcome was weighted for quality of life with use of a utility factor, and effectiveness was expressed in units of quality-adjusted life years. Gross costs were estimated from Medicare charge and reimbursement data for the relevant codes. The effect of the uncertainty of estimates of costs and effectiveness was assessed with sensitivity analysis.

Results: The reference case of our model assumed a ten-year duration of survival of the prosthesis, resulting in an incremental cost-effectiveness ratio for ankle arthroplasty of $18,419 per quality-adjusted life year gained. This reflects a gain of 0.52 quality-adjusted life years at a cost of $9578 when ankle arthroplasty is chosen over fusion. This ratio compares favorably with the cost-effectiveness of other medical and surgical interventions. Sensitivity analysis determined that the cost per quality-adjusted life year gained with ankle arthroplasty rises above $50,000 if the prosthesis is assumed to fail before seven years. Treatment options with ratios above $50,000 per quality-adjusted life year are commonly considered to have limited cost-effectiveness. This threshold is also crossed when the theoretical functional advantages of ankle arthroplasty are eliminated in sensitivity analysis.

Conclusions: The currently available literature has not yet shown that total ankle arthroplasty predictably results in levels of durability and function that make it cost-effective at this time. However, the reference case of this analysis does demonstrate that total ankle arthroplasty has the potential to be a cost-effective alternative to ankle fusion. This reference case assumes that the theoretical functional advantages of ankle arthroplasty over ankle fusion will be borne out in future clinical studies. Performance of total ankle replacement will be better justified if these thresholds are met in published long-term clinical trials.

Level of Evidence: Economic and decision analysis, Level II-1 (clinically sensible costs and alternatives; values obtained from limited studies; multiway sensitivity analyses). See Instructions to Authors for a complete description of levels of evidence.