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.

Abstract

Purpose: Patient-specific instrumentation (PSI) is a commonly used technique designed to improve mechanical alignment in total knee arthroplasty (TKA) and was therefore believed to lead to better clinical outcome and implant survival rates compared with conventional instruments (CIs). To date, long-term results comparing these two techniques are not available.

Methods: This study is a 10-year follow-up of a previous double-blind multicenter randomized controlled trial where PSI was compared with CI. Patients with osteoarthritis of the knee who were candidates for TKA were included. Exclusion criteria were metal near the knee-, ankle- or hip joint, patients with contra-indications for a magnetic resonance imaging (MRI) scan and patients who had previous knee surgery (except arthroscopic meniscectomy). Clinical outcomes were assessed using patient-reported outcome measures (PROMs), and the analysis was performed with a general linear mixed model for repeated measurements. Kaplan-Meier curves were used to compare revision rates. X-rays were obtained and examined by two individual reviewers for any signs of loosening of the components.

Results: At a mean follow-up of 10.1 (SD 0.1) years, 129 patients (loss to follow-up 23%) were analysed in this trial. No statistically significant difference between the two groups were found for any of the PROMs and revision rates were comparable, six in the PSI group and three in the CI group (p = 0.29). Two X-rays in the PSI group showed a radiolucent line of the femoral component.

Conclusion: At 10-year follow-up, PSI does not lead to better clinical outcome or survival of the prosthesis compared with CI.

Level of evidence: 1: