Implant brand portfolios, the potential for camouflage of data, and the role of the Orthopaedic Data Evaluation Panel in total knee arthroplasty

Author:

Phillips Jonathan Robert Anthony1ORCID,Tucker Keith2

Affiliation:

1. Exeter Knee Reconstruction Unit, Royal Devon and Exeter Hospital, Exeter, UK

2. Orthopaedic Data Evaluation Panel, UK

Abstract

Aims Knee arthroplasty surgery is a highly effective treatment for arthritis and disorders of the knee. There are a wide variety of implant brands and types of knee arthroplasty available to surgeons. As a result of a number of highly publicized failures, arthroplasty surgery is highly regulated in the UK and many other countries through national registries, introduced to monitor implant performance, surgeons, and hospitals. With time, the options available within many brand portfolios have grown, with alternative tibial or femoral components, tibial insert materials, or shapes and patella resurfacings. In this study we have investigated the effect of the expansion of implant brand portfolios and where there may be a lack of transparency around a brand name. We also aimed to establish the potential numbers of compatible implant construct combinations. Methods Hypothetical implant brand portfolios were proposed, and the number of compatible implant construct combinations was calculated. Results A simple knee portfolio with cemented cruciate-retaining (CR) and posterior-stabilized (PS) components, with and without a patella, has four combinations. If there are two options available for each component, the numbers double for each option, resulting in 32 combinations. The effect of adding a third option multiplies the number by 1.3. Introducing compatible uncemented options, with the effect of hybrids, multiplies the number by 4. An implant portfolio with two femoral components (both in CR and PS), with two insert options and a patella, all in cemented and uncemented versions leads to 192 possible compatible implant construct combinations. There are implant brands available to surgeons with many more than two options. Conclusion This study demonstrates that the addition of multiple variants within a knee brand portfolio leads to a large number (many hundreds) of compatible implant construct combinations. Revision rates of implant combinations are not currently reviewed at this level of granularity, leading to the risk of camouflage of true outcomes. Cite this article: Bone Joint J 2021;103-B(10):1555–1560.

Publisher

British Editorial Society of Bone & Joint Surgery

Subject

Orthopedics and Sports Medicine,Surgery

Reference7 articles.

1. No authors listed. NJR 17th Annual Report 2020. National Joint Registry. 2020. https://reports.njrcentre.org.uk/Portals/0/PDFdownloads/NJR%2017th%20Annual%20Report%202020.pdf (date last accessed 10 August 2021).

2. No authors listed. The Scottish Arthroplasty Project. Public Health Scotland. 2020. https://www.arthro.scot.nhs.uk (date last accessed 10 August 2021).

3. No authors listed. NJR 7th annual report. National Joint Registry. https://reports.njrcentre.org.uk (date last accessed 12 July 2021).

4. No authors listed. Medicines & Healthcare products Regulatory Agency. Gov.uk. https://www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency/about (date last accessed 12 July 2021).

5. Orthopaedic Data Evaluation Panel. Orthopaedic data evaluation panel. www.odep.org.uk (date last accessed 12 July 2021).

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