Long-term survival of the uncemented femoral component of Vanguard Total Knee Arthroplasty: A post-market clinical follow-up study.

INTRODUCTION/

OBJECTIVES

The long-term safety and clinical outcomes of the uncemented femoral Vanguard Total Knee Arthroplasty (TKA) System have yet to be analyzed. The primary objective of this study is to address the following research question: What is the long-term survival rate, with a minimal of 10 years follow-up?

METHODS

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 University Medical Centre (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.

RESULTS

In total, 141 TKAs were included. The survival rate of the femoral component was 97.2% (95% confidence interval [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 per specific subscales were 85.7 (IQR: 64.3-97.3) for the symptom subscale, 94.4 (IQR: 83.3-100) for the pain subscale, 91.9 (IQR: 70.2-98.5) for the Activities of Daily Living subscale, 40.0 (IQR: 20.0-77.5) for the sport and recreation subscale, and 75.0 (IQR: 50.0-100) for the Quality of Life subscale. The median OKS was 41.5 (IQR: 37.3-45.0).

CONCLUSION

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.

CLINICAL TRIAL REGISTRATION: The study protocol was registered with the Centrale Commissie Mensgebonden Onderzoek (CCMO) at https://onderzoekmetmensen.nl/nl/trial/56781 LEVEL OF EVIDENCE: IV.