No significant difference in early clinical outcomes of custom versus off-the-shelf total knee arthroplasty: a systematic review and meta-analysis

Knee Surg Sports Traumatol Arthrosc. 2023 Apr;31(4):1230-1246. doi: 10.1007/s00167-021-06678-6. Epub 2021 Aug 25.


Purpose: The purpose of this systematic review and meta-analysis was to collect, synthesise and critically appraise findings of clinical studies that report outcomes of custom total knee arthroplasty (TKA). The hypothesis was that, compared to off-the-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 effect in favour of OTS TKA (odds ratio (OR), 0.4; p = n.s.) but the result did not reach statistical significance. Four studies found no statistically significant difference in KSS knee (standardised mean difference (SMD), - 0.10; p = n.s.) and function (SMD, 0.03; p = n.s.), and five studies found no statistically significant difference in range of motion (SMD, 0.02; p = n.s.). One study that compared bone-implant fit 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 significant benefits compared to OTS TKA in terms of pooled clinical outcomes, but had considerably higher early revision rates. The findings 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.

Keywords: Arthroplasty; Custom; Knee; Patient-specific; Replacement; TKA; Total knee arthroplasty.

Publication types

  • Meta-Analysis
  • Systematic Review
  • Review

MeSH terms

  • Arthroplasty, Replacement, Knee* / methods
  • Cross-Sectional Studies
  • Humans
  • Knee Joint / surgery
  • Osteoarthritis, Knee* / surgery
  • Range of Motion, Articular
  • Tibia / surgery
  • Treatment Outcome