Functional outcomes in patient specific instrumentation vs. conventional instrumentation for total knee arthroplasty; a systematic review and meta-analysis of prospective studies

Abstract Background Total Knee Arthroplasty (TKA) is an established surgical option for knee osteoarthritis (OA). There are varying perceptions of the most suitable surgical technique for making bone cuts in TKA. Conventional Instrumentation (CI) uses generic cutting guides (extra- and intra-medullary) for TKA; however, patient specific instrumentation (PSI) has become a popular alternative amongst surgeons. Methods A literature search of electronic databases Embase, Medline and registry platform portals was conducted on the 16th May 2021. The search was performed using a predesigned search strategy. Eligible studies were critically appraised for methodological quality. The primary outcome measure was Knee Society Function Score. Functional scores were also collected for the secondary outcome measures: Oxford Knee Score (OKS), Western Ontario and McMaster Universities Arthritis Index (WOMAC), Knee Injury and Osteoarthritis Outcome Score (KOOS) and Visual Analog Scale (VAS) for pain. Review Manager 5.3 was used for all data synthesis and analysis. Results There is no conclusive evidence in the literature to suggest that PSI or CI instrumentation is better for functional outcomes. 23 studies were identified for inclusion in this study. Twenty-two studies (18 randomised controlled trials and 4 prospective studies) were included in the meta analysis, with a total of 2277 total knee arthroplasties. There were 1154 PSI TKA and 1123 CI TKA. The majority of outcomes at 3-months, 6-months and 12 show no statistical difference. There was statistical significance at 24 months in favour of PSI group for KSS function (mean difference 4.36, 95% confidence interval 1.83–6.89). The mean difference did not exceed the MCID of 6.4. KSS knee scores demonstrated statistical significance at 24 months (mean difference 2.37, 95% confidence interval (CI) 0.42—4.31), with a MCID of 5.9. WOMAC scores were found to be statistically significant favouring PSI group at 12 months (mean difference -3.47, 95% confidence interval (CI) -6.57- -0.36) and 24 months (mean difference -0.65, 95% confidence interval (CI) -1.28—-0.03), with high level of bias noted in the studies and a MCID of 10. Conclusions This meta-analysis of level 1 and level 2 evidence shows there is no clinical difference when comparing PSI and CI KSS function scores for TKA at definitive post operative time points (3 months, 6 months, 12 months and 24 months). Within the secondary outcomes for this study, there was no clinical difference between PSI and CI for TKA. Although there was no clinical difference between PSI and CI for TKA, there was statistical significance noted at 24 months in favour of PSI compared to CI for TKA when considering KSS function, KSS knee scores and WOMAC scores. Studies included in this meta-analysis were of limited cohort size and prospective studies were prone to methodological bias. The current literature is limited and insufficiently robust to make explicit conclusions and therefore further high-powered robust RCTs are required at specific time points