A randomized prospective study comparing mobile-bearing against fixed-bearing PFC Sigma cruciate-retaining total knee arthroplasties with ten-year minimum follow-up

Abstract

AIMS: This study compares the PFC total knee arthroplasty (TKA) system in a prospective randomized control trial (RCT) of the mobile-bearing rotating-platform (RP) TKA against the fixed-bearing (FB) TKA. This is the largest RCT with the longest follow-up where cruciate-retaining PFC total knee arthroplasties are compared in a non-bilateral TKA study. PATIENTS AND METHODS: (20 to 52) and 73 patients were female. The Knee Society Score (KSS), Knee Society Functional Score (KSFS), Oxford Knee Score (OKS), Western Ontario and McMaster Universities Arthritis Index (WOMAC), and 12-Item Short-Form Health Survey Physical and Mental Component Scores (SF-12 PCS, SF-12 MCS) were gathered and recorded preoperatively, at five-years' follow-up, and at ten years' follow-up. Additionally, Knee Injury and Osteoarthritis Outcome Scores (KOOS) were collected at five- and ten-year follow-ups. The prevalence of radiolucent lines (RL) on radiographs and implant survival were recorded at five- and ten-year follow-ups. RESULTS: At the ten-year follow-up, the RP group (n = 39) had a statistically significant superior score in the OKS (p = 0.001), WOMAC (p = 0.023), SF-12 PCS (p = 0.019), KOOS Activities of Daily Living (ADL) (p = 0.010), and KOOS Sport and Recreation (Sport/Rec) (p = 0.006) compared with the FB group (n = 46). The OKS, SF-12 PCS, and KOOS Sport/Rec at ten years had mean scores above the minimal clinically important difference (MCID) threshold. There was no significant difference in prevalence of radiolucency between groups at five-years' follow-up (p = 0.449), nor at ten-years' follow-up (p = 0.08). Implant survival rate at 14 years postoperative was 95.2 (95% CI 90.7 to 99.8) and 94.7 (95% CI 86.8 to 100.0) for the RP and FB TKAs, respectively. CONCLUSION: At ten-year follow-up, the mobile-bearing knee joint arthroplasty had statistically and clinically relevant superior OKS, SF-12 PCS, and KOOS (Sport/Rec) than the fixed-bearing platform. No difference was seen in prevalence of radiolucent lines. There was a greater than 94% implant survival rate for both cohorts at 14 years. Cite this article: Bone Joint J 2018;100-B:1336-44.