Early-Term Results of the Cadence Total Ankle Prosthesis: An European Noninventor Study.

ABSTRACT

BACKGROUND: Although considerable literature can be found on the outcome of total ankle replacement (TAR), only a few studies have reported the results of the fixed-bearing Cadence prosthesis. This noninventor study reports a consecutive series of 60 Cadence TAR systems with a mean of 2.9 years' follow-up, focusing on clinical and radiographic outcomes and early complications. This study is the first to assess true postoperative radiographic ankle prosthesis range of motion (ROM) and to report an unanticipated serious adverse device effect. METHODS: Sixty patients who underwent primary TAR with the Cadence prosthesis between July 2016 and July 2019 were clinically and radiographically evaluated preoperatively and at last follow-up after the procedure. Revisions, additional procedures, implant failure, and complications were reported according to the classifications of Vander Griend and Glazebrook. Radiographic outcomes included radiographic TAR ROM, bone-implant interface, and alignment parameters. RESULTS: The survival rate of the prosthesis was 98.3%. The mean radiographic ankle ROM at the last follow-up was 24 degrees (9 degrees of dorsiflexion and 15 degrees of plantarflexion). The coronal and sagittal alignment of TAR was 90.8 degrees and 3.9 degrees, respectively. Bone-implant interface analysis revealed osteolysis in 9 ankles (15%) and radiolucent lines in 33 ankles (55%) occurring at both component interfaces. Intraoperative complications were 3 periprosthetic malleolar fractures (5%). Five talar implant fractures (implant failure of 8.3%) were observed, and 1 unexplained persistent pain that required a conversion from TAR to a tibiotalocalcaneal arthrodesis. CONCLUSION: Clinical, radiograph ROM, implant position outcomes, and survival rate at an early-term follow-up of 2.9 years were similar to those reported in recent Cadence studies. However, this study reports 5 unanticipated talar implant fractures and a high rate of posterior radiolucent lines. LEVEL OF EVIDENCE Level IV, retrospective case series.