Purpose The purpose of this systematic review and meta-analysis was to collect, synthesise and critically appraise indings of clinical studies that report outcomes of custom total knee arthroplasty (TKA). The hypothesis was that, compared to ofthe-shelf (OTS) TKA, custom TKA would yield better surgical, clinical and radiographic outcomes. Methods This systematic review and meta-analysis was performed in accordance with the guidelines of Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA). On 8 February 2021, two authors independently searched and screened articles using MEDLINE®, Embase® and the Cochrane Library without restriction on date of publication. Findings from eligible articles were narratively synthesised and tabulated, and when ≥ 3 comparative studies reported the same outcome, results were pooled and summarised in forest plots. Quality assessments of the studies were done according to the guidelines of the Joanna Briggs Institute (JBI) Checklists. Results A total of 15 articles were eligible for data extraction, of which 9 were case-control studies reporting on 929 custom versus 998 OTS TKA, 5 were case series reporting on results of 587 custom TKA, and 1 was a cross-sectional study reporting on results of 44 custom versus 132 OTS TKA. Five studies that compared early revision rates found the overall efect in favour of OTS TKA (odds ratio (OR), 0.4; p = n.s.) but the result did not reach statistical signiicance. Four studies found no statistically signiicant diference in KSS knee (standardised mean diference (SMD), − 0.10; p = n.s.) and function (SMD, 0.03; p = n.s.), and ive studies found no statistically signiicant diference in range of motion (SMD, 0.02; p = n.s.). One study that compared bone-implant it between custom and three OTS tibial components found no overhang but revealed under-coverage of up to 18% in knees with custom tibial baseplates. Conclusion Custom TKA demonstrated no signiicant beneits compared to OTS TKA in terms of pooled clinical outcomes, but had considerably higher early revision rates. The indings of the present systematic review and meta-analysis suggest the need for studies with better comparable groups and standardisation of reporting outcomes amongst studies, that could increase the quality of evidence and enable pooling of results in future meta-analyses. Level of evidence Level IV.
KeywordsArthroplasty • Replacement • Knee • Total knee arthroplasty • TKA • Custom • Patient-speciic European Knee Associates (EKA) members are listed in the Acknowledgement section.