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

Abstract

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.

The ceramic coated implant (CCI). Evolution total ankle replacements: a retrospective analysis of 40 ankles with 8 years follow-up

“…Voesenek et al 14 reported 37% postoperative complications including impingement, deep infection, delayed wound healing, and minor nerve injuries in short-term. Altogether, complications including all re-operations were recorded in 64% of ankles in our study and in 45% of the ankles in the study by van Es et al 9 . However, not all complications are the same in terms of the risk for implant failure, and only one-fifth of the complications in our study feasible to be defined by classification system developed based on the severity were high-grade 15 .…”

“…The largest study of 254 CCI implants with long-term results was published recently by van Es with 10-year follow-up 9 . They reported a 67.5% 10-year survival rate for all cause revision with a median follow-up of 6.9 (range 0.04-13.9) years with a mean time to revision of 4.5 (range 0.04-12.2) years.…”

Alignment of CCI total ankle replacements in relation to midterm functional outcome and complication incidence

“…Similar complication and reoperation rates were found in the designer study which presented results of the Buechel‐Pappas and CCI prosthesis [18]. The 10‐year follow‐up study of the same group 45% of the total ankle replacements had developed a complication of which only 16% was treated conservatively [19]. Causes for impingement could be component malrotation that will always lead to gutter impingement [30, 31].…”

“…In this study, the 5‐year follow‐up results of 75 CCI ankle prosthesis and 15 Buechel‐Pappas ankle prostheses showed a survival rate of 87% in the postfracture group and 79% in the instability group [18]. Recently the group of Doets reported even a lower survival rate of 67.5% at 10‐year follow‐up [19].…”

“…First report presented both the Buechel-Pappas and the CCI ankle prosthesis showing a survival of 87% in the post fracture group and 79% in the instability group at 6 years of follow-up [18]. The other designer study reported a survival rate of 67.5% at 10-year follow-up, with a complication rate of 54% and 37% patients underwent reoperation [19]. This is the first non-designer study to report the midterm clinical results of the Ceramic Coated Implant (CCI) ankle replacements.…”