Abstract
BACKGROUND AND PURPOSE: Patient-specific instrumentation (PSI) in total knee arthroplasty (TKA) aims to improve implant alignment and clinical outcomes, but its effectiveness remains uncertain. We aimed to compare whether PSI was superior to conventional instrumentation (CVI) in TKA. The primary outcome was the Oxford Knee Score (OKS) at 2 years with assessments of additional clinical outcomes up to 5 years after surgery. METHODS: This study included 70 knees with primary osteoarthritis randomized (1:1) to undergo TKA using either PSI or CVI. Outcomes were evaluated using patient-reported outcome measures (PROMs), radiographic alignment, and radiostereometric analysis (RSA) of migration over the full follow-up period of 5 years. RESULTS: 68 knees underwent surgery as per protocol. At 2 years, 29 knees in the PSI group and 36 in the CVI group were assessed with the OKS, which improved significantly by 21.2 in the PSI group and 18.2 in the CVI group (mean difference [MD] 2.1; 95% confidence interval [CI] -1.5 to 5.7). PSI resulted in slightly increased tibial varus alignment (MD -1.4°; CI -2.3° to -0.4°), migrated slightly more into varus (mean difference at 2 years: -0.28 mm, CI -0.54 to -0.03 mm), and showed higher maximum total point motion (MTPM) during the period 1 to 2 years (mean difference: 0.13 mm; CI 0.01-0.25). At 5 years, 3 knees had been revised (PSI: 2; CVI: 1). CONCLUSION: PSI did not demonstrate superior outcomes compared with CVI. These findings suggest that PSI may not provide significant benefits over conventional techniques in routine TKA.