Long-term Follow-up of 254 Ceramic Coated Implant (CCI) Evolution Total Ankle Replacements

Background: The ceramic coated implant (CCI) Evolution was a third-generation implant design used in approximately 2000 total ankle replacements (TARs) between 2003 and 2016. Because this implant was abandoned, long-term follow-up studies are lacking. Methods: All patients undergoing TAR using a CCI prosthesis between 2004 and 2012 were included for analysis. Preoperatively the tibiotalar alignment was measured, and postoperatively the patients were followed up clinically, with radiographs and by questionnaire. The primary outcome was implant survival at 10 years of follow-up. Implant survival was also compared for (1) inflammatory joint disease vs noninflammatory joint disease and (2) preoperative tibiotalar neutral vs varus or valgus alignment. The secondary outcomes were complications, reoperations, and function (assessed by patient-reported outcome measures). Results: Two hundred fifty-four TARs were performed in 237 patients. Two hundred twelve additional procedures were performed to achieve stable ankles. At 10-year follow-up, the survival was 67.5%, with an average time to revision of 4.5 years. The 10-year survival of the inflammatory joint disease group was 76.8% and of the noninflammatory joint group 63.1% (P =.44). In 248 TARs, the preoperative tibiotalar alignment was measured; (62% neutral, 25% varus, and 13% valgus), these showed 10-year survival rates of 74.7%, 48.2%, and 68.9% respectively (P =.07). The complication rate was 54%; 37% of patients underwent reoperation. At a mean of 8.5 years, postoperative satisfaction scored an average of 7.0 (SD 2.26) on a 0- to 10-point numeric rating scale. The mean Foot and Ankle Ability Measure sports subscore was 24.7, the mean Foot and Ankle Outcome Score (FAOS) sports subscore was 42.8, and the mean 36-Item Short Form Health Survey score was 40.0. Regarding daily activities, the mean FAOS was 81.0. Conclusion: This is currently the sole study reporting the long-term results of the CCI prosthesis. The survival and functional outcomes were inferior to other third-generation mobile-bearing ankle implants.