Minimum 5-Year Outcomes of a Multicenter, Prospective, Randomized Control Trial Assessing Clinical and Radiological Outcomes of Patient-Specific Instrumentation in Total Knee Arthroplasty

Patient-specific instrumentation (PSI) was developed to produce more accurate alignment of components and consequently improve clinical outcomes when used in total knee arthroplasty. We compare radiological accuracy and clinical outcomes at a minimum of 5-year follow-up between patients randomized to undergo total knee arthroplasty performed using PSI or traditional cutting block techniques. This multicenter, randomized control trial included patients blinded to the technique 1used. Outcome measures were coronal alignment measured radiologically, Euroqol-5D, Oxford knee score, and International Knee Society Score measured at 1- and 5-year follow-up. At a minimum 5-year follow-up, there were 38 knees in the PSI group and 39 in the conventional instrumentation group for analysis. Baseline demographics and clinical outcome scores were matched between groups. Overall, there was no significant difference in the coronal femoral angle (P = .59), coronal tibial angle (P = .37), tibiofemoral angle (P = .99), sagittal femoral angle (P = .34), or the posterior tibia slope (P = .12) between knees implanted using PSI and those implanted with traditional cutting blocks. On the measurement of coronal alignment, intraobserver reliability tests demonstrated substantial agreement (k = 0.64). Clinical outcomes at both 1-year and 5-year follow-up demonstrated statistically significant and clinically relevant improvement in scores from baseline in both groups, but no difference could be detected between the Euroqol-5D (P = .78), Oxford knee score (P = .24), or International Knee Society Score (P = .86) between the 2 groups. This study has shown no additional benefit to PSI in terms of improved alignment or functional outcomes at minimum 5-year follow-up over traditional techniques.