Early experience and patient-reported outcomes of 503 INFINITY total ankle arthroplasties

Aims This is a multicentre, non-inventor, prospective observational study of 503 INFINITY fixed bearing total ankle arthroplasties (TAAs). We report our early experience, complications, and radiological and functional outcomes. Methods Patients were recruited from 11 specialist centres between June 2016 and November 2019. Demographic, radiological, and functional outcome data (Ankle Osteoarthritis Scale, Manchester Oxford Questionnaire, and EuroQol five-dimension five-level score) were collected preoperatively, at six months, one year, and two years. The Canadian Orthopaedic Foot and Ankle Society (COFAS) grading system was used to stratify deformity. Early and late complications and reoperations were recorded as adverse events. Radiographs were assessed for lucencies, cysts, and/or subsidence. Results In all, 500 patients reached six-month follow-up, 420 reached one-year follow-up, and 188 reached two-year follow-up. The mean age was 67.8 years (23.9 to 88.5). A total of 38 patients (7.5%) presented with inflammatory arthritis. A total of 101 (20.0%) of implantations used patient-specific instrumentation; 167 patients (33.1%) underwent an additional procedure at the time of surgery. A total of seven patients died of unrelated causes, two with-drew, and one was lost to follow-up. The mean follow-up was 16.2 months (6 to 36). There was a significant improvement from baseline across all functional outcome scores at six months, one, and two years. There was no significant difference in outcomes with the use of patient-specific instrumentation, type of arthritis, or COFAS type. Five (1.0%) implants were revised. The overall complication rate was 8.8%. The non-revision reoperation rate was 1.4%. The 30-day readmission rate was 1.2% and the one-year mortality 0.74%. Conclusion The early experience and complications reported in this study support the current use of the INFINITY TAA as a safe and effective implant in the treatment of end-stage ankle arthritis.