Long-term survival of the uncemented femoral component of Vanguard Total Knee Arthroplasty: A Post-Market Clinical Follow-up study.

Abstract

The long-term safety and clinical outcomes of the uncemented femoral Vanguard Total Knee Arthroplasty (TKA) System have yet to be analysed. The primary objective of this study is to address the following research question: What is the long-term survival rate, with a minimal of ten years follow-up? A cross-sectional post-market clinical follow-up study was conducted. All patients treated with a TKA System, incorporating the specific femoral component, at the Amsterdam UMC, between 2009 and 2013, were identified and included consecutively. The primary outcome was the long-term survival of the femoral component. A secondary outcome was the survival of the complete TKA system. Additional secondary outcomes for a subgroup of patients were physical examinations, the Oxford Knee Score (OKS) and Knee Injury and Osteoarthritis Outcome score (KOOS) patient reported outcome measures (PROMs). 141 TKAs were included. The survival rate of the femoral component was 97.2% (95%CI:93.9-100) at a median follow-up time of 12.0 years (interquartile range (IQR):11.17-13.28). The survival rate of the complete TKA system was 90.1% (95%CI:83.0-97.2). Of a small subgroup of 50 TKAs included in the tertiary research question, the median KOOS-scores per specific subscales were 85.7 (IQR:64.3-97.3) for Symptom, 94.4 (IQR:83.3-100) for Pain, 91.9 (IQR:70.2-98.5) for Activities of Daily Living, 40.0 (IQR:20.0-77.5) for Sport and Recreation and 75.0 (IQR:50.0-100) for Quality of Life. The median OKS-score was 41.5 (IQR:37.3-45.0). The Vanguard Posterior Stabilized Open Box Porous Femoral component demonstrated a survival rate of 97.2% after a median follow-up of 12.0 years, with favorable long-term clinical and functional outcomes. This component is safe for continued use. The study protocol was registered with the CCMO at https://onderzoekmetmensen.nl/nl/trial/56781 LEVEL OF EVIDENCE: Level IV.