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

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Knee Surgery, Sports Traumatology, Arthroscopy Aims and scope

Abstract

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.

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Acknowledgements

The authors are grateful to Luca Nover for assistance with data extraction. The authors also gratefully acknowledge the contribution of Mo Saffarini, M.Eng, MBA, FRSM, (Mail: mo@resurg.com, Orcid: http://orcid.org/0000-0002-9656-987X). ReSurg SA, Nyon, Switzerland; Markus P Arnold, MD, PhD, Practice LEONARDO, Hirslanden Klinik Birshof, Münchenstein, Switzerland; Faculty of Medicine, University of Basel, Basel, Switzerland. Johannes Beckmann, MD, PhD, 8.Sportklinik Stuttgart, Taubenheimstr. 8, 70372, Stuttgart, Germany.

European Knee Associates (EKA)

The contributors of the European Knee Associates (EKA) are: Mo Saffarini; Markus P Arnold: Practice LEONARDO, Hirslanden Klinik Birshof, Münchenstein, Switzerland. Faculty of Medicine, University of Basel, Basel, Switzerland; Johannes Beckmann: Sportklinik Stuttgart, Taubenheimstr. 8, 70372, Stuttgart, Germany.

Funding

The authors are grateful to “GCS Ramsay Santé pour l’Enseignement et la Recherche” for funding the statistical analysis and manuscript preparation for this study.

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Authors and Affiliations

  1. ReSurg SA, Rue Saint-Jean 22, 1260, Nyon, Switzerland

    Jacobus H. Müller & Patrick Stirling

  2. Department of Orthopaedics and Traumatology, Medical University of Innsbruck, Anichstraße 35, 6020, Innsbruck, Austria

    Michael Liebensteiner

  3. CortoClinics, Schijndel, The Netherlands

    Nanne Kort

  4. IMUKA, Roosteren, The Netherlands

    Peter Pilot

  5. Lyon-Ortho-Clinic, Clinique de la Sauvegarde, Ramsay Santé, 29 Avenue des Sources, 69009, Lyon, France

    Guillaume Demey

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  1. Jacobus H. Müller
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European Knee Associates (EKA)

  • Mo Saffarini
  • , Markus P. Arnold
  •  & Johannes Beckmann

Contributions

JHM: study design, literature search, data extraction, statistical analysis, manuscript preparation, and project coordination. ML: study design and manuscript enhancement. NK: study design and manuscript fine-tuning. PS: study design, literature search, data extraction, and manuscript preparation. PP: study design and manuscript improvement. GD: study design and manuscript fine-tuning. MS: study design, manuscript enhancement, and project coordination. MPA: study design and manuscript fine-tuning. JB: study design and manuscript fine-tuning.

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Conflict of interest

JHM, PS, PP, and GD have nothing to disclose. ML reports receiving honoraria from DePuy, and Stryker outside the submitted work. NK reports personal fees from BodyCad, Stryker, Zimmer-Biomet, and Bioventus outside the submitted work. MPA reports being a consultant for ConforMIS and Symbios outside the submitted work. JB reports receiving honoraria from DePuy, Smith + Nephew, and ConforMIS outside the submitted work.

Ethical statement

This was a systematic review and meta-analysis of published results, and therefore, IRB approval was not necessary.

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European Knee Associates (EKA) members are listed in the Acknowledgement section.

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Müller, J.H., Liebensteiner, M., Kort, N. et al. 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 31, 1230–1246 (2023). https://doi.org/10.1007/s00167-021-06678-6

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