Patient-specific instrumentation improved clinical outcome and implant survival but is not superior compared to conventional total knee arthroplasty: Ten years follow-up of a multicenter double-blind randomized controlled trial.

研究概要

A total of 180 patients with knee osteoarthritis were randomized to receive either patient-specific instrumentation (PSI) (n=90) or conventional instrumentation (CI) (n=90) during total knee arthroplasty. The primary outcome of interest was the difference in patient-reported outcome measures (PROMs), including the Oxford Knee Score (OKS), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), pain visual analogue scale (VAS), EQ-5D index and VAS, and Forgotten Joint Score (FJS). Secondary outcomes included implant survival and the presence of radiolucent lines on X-ray at 10 years. Outcomes were assessed preoperatively and at 3 months, 1, 2, 5, and 10 years. Overall, the results of the study revealed that although all PROMs improved over time in both groups, no statistically significant differences were found between PSI and CI for any PROM at 10 years. Revision rates were also comparable. These findings suggest that while PSI does not provide superior long-term clinical outcomes or implant survival over CI, both techniques result in significant improvements in patient outcomes.