Abstract
The use of rotating hinge (RH) prostheses for severe primary as well as revision arthroplasty is widely established. Aim of this study was to investigate long term results of a new RH prosthesis (EnduRo®, B Braun, Germany), which uses carbon-fiber reinforced poly-ether-ether-ketone (CFR PEEK) as a new bearing material, first time used in knee arthroplasty.
Fifty-six consecutive patients, who received the EnduRo® RH prosthesis were included in this prospective study: 21 patients (37.5%) received the prosthesis as a primary total knee arthroplasty (TKA) and 35 patients (62.5%) underwent revision total knee arthroplasties (rTKA). Clinical and radiographic examinations were performed preoperatively as well as postoperatively after 3 and 12 months and annually thereafter. Min. Follow up was 7 and mean follow up 9,3 years. Clinical examination included Knee Society Score (KSS), Western Ontario and McMaster Osteoarthritis Index (WOMAC), Oxford Knee Score (OKS), and range of motion (ROM). Competing risk analysis was assessed for survival with respect to indication and failure mode.
KSS, WOMAC, OKS, and ROM significantly improved from the preoperative to the follow up investigations (p < 0.0001). There was no difference in clinical outcome between the primary and the revision group. The overall cumulative incidence for revision for any reason was 23.6% and the cumulative incidence for complications associated with failure of the prothesis was 5.6% at 7 years, respectively. Complications occurred more frequently in the revision group (p = 0.002).
The evaluated RH prosthesis provided reliable and durable results with a minimum follow-up of 7 years. Prosthesis survival was successful considering the complexity of cases. The use of this RH system in primary patients showed high survival rates. Long-term functional and clinical results proved to be satisfying in both revision and primary cases. No adverse events were associated with the new bearing material CFR-PEEK.
