Outcome of kinematic alignment using patient-specific instrumentation versus mechanical alignment in TKA: a meta-analysis and subgroup analysis of randomised trials

This is the author accepted manuscript. The final version is available from Springer via the DOI in this record. Introduction Kinematic alignment (KA) in total knee arthroplasty (TKA) matches component position to the pre-arthritic anatomy of an individual patient, with the aim of improving functional outcomes. Recent randomised controlled trials (RCTs) comparing KA to traditional neutral mechanical alignment (MA) have been mixed. This collaborative study combined raw data from RCTs, aiming to compare functional outcomes between KA using patient-specific instrumentation (PSI) and MA, and whether any patient subgroups may benefit more from KA technique. Materials and methods A literature search in PubMed, EMBASE and Cochrane databases identified four randomised controlled trials comparing patients undergoing TKA using PSI-KA and MA. Unpublished data including Western Ontario McMaster Universities Arthritis Index (WOMAC) and Knee Society Score (KSS) were obtained from study authors. Metaanalysis compared MA to KA change (post-op minus pre-op) scores. Subgroup-analysis on KA patients looked for subgroups more likely to benefit from KA and the impact of PSI accuracy. Results Meta-analyses of change scores in 229 KA patients versus 229 MA patients were no different from WOMAC (mean difference 3.4; 95% confidence interval − 0.5 to 7.3), KSS function (1.3, − 3.9 to 6.4) or KSS combined (7.2, − 0.8 to 15.2). A small advantage was seen for KSS pain in the KA group (3.6, 95% CI 0.2–7.1). Subgroup-analysis showed no difference between varus, valgus and neutral pre-operative alignment groups, and those who did and did not achieve KA plans. Painfree patients at 1-year were more likely to achieve KA plans. Conclusion Patient-reported outcome scores following TKA using PSI-KA are similar to MA. No identifiable subgroups benefited more from KA, and long-term results remain unknown. Inaccuracy of the PSI system used in KA patients could potentially affect outcome