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Knee registries: state of the art
  1. Eran Beit Ner1,2,
  2. Norimasa Nakamura3,4,
  3. Christian Lattermann5,
  4. Michael James McNicholas6,7
  1. 1Department of Trauma and Orthopaedic Surgery, Manchester University NHS Foundation Trust, Manchester, UK
  2. 2Department of Orthopedic Surgery, Yitzhak Shamir Medical Center (Assaf Harofeh), affiliated to the Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv, Israel, Zerifin, Israel
  3. 3Global Center of Medical Engineering and Informatics, Osaka University, Osaka, Japan
  4. 4Orthopaedic Surgery, Osaka University Graduate School of Medicine, Osaka, Japan
  5. 5Department of Orthopaedic Surgery MassGeneralBrigham (MGB), Brigham and Women’s Distinguished Chair in Orthopaedic Surgery Chief: Division of Sports Medicine Director: Cartilage Repair Center Brigham and Women’s Hospital Harvard Medical School, Chestnut Hill, Massachusetts, USA
  6. 6Trauma and Orthopaedics, Liverpool University Hospitals NHS Foundation Trust, Liverpool, UK
  7. 7Division of Cell Matrix Biology and Regenerative Medicine, Faculty of Biology, Medicine and Health, School of Biological Sciences, The University of Manchester, Manchester, UK
  1. Correspondence to Michael James McNicholas, Trauma and Orthopaedics, Liverpool University Hospitals NHS Foundation Trust, Liverpool L14 3LB, UK; mike.mcnicholas{at}liverpoolft.nhs.uk

Abstract

Sports injuries, trauma and the globally ageing and obese population require increasing levels of knee surgery. Shared decision making has replaced the paternalistic approach to patient management. Evidence-based medicine underpins surgical treatment strategies, from consenting an individual patient to national healthcare system design. The evolution of successful knee-related registries starting from specific arthroplasty registries has given rise to ligament reconstruction, osteotomy and cartilage surgery registries developing as platforms for surgical outcome data collection. Stakeholders include surgeons and their patients, researchers, healthcare systems, as well as the funding insurers and governments. Lately, implant manufacturers have also been mandated to perform postmarket surveillance with some hoping to base that on registry data.

Aiming to assess the current status of knee-related registries, we performed a comprehensive literature and web search, which yielded 23 arthroplasty, 8 ligament, 4 osteotomy and 3 articular cartilage registries. Registries were evaluated for their scope, measured variables, impact and limitations.

Registries have many advantages as they aim to increase awareness of outcomes; identify trends in practice over time, early failing implants, outlier surgeon or institution performance; and assist postmarketing surveillance. International collaborations have highlighted variations in practice. The limitations of registries are discussed in detail. Inconsistencies are found in collected data and measured variables. Potential measurement and selection biases are outlined. Without mandated data collection and with apparent issues such as unverified patient reporting of complications, registries are not designed to replace adverse event recording in place of a proper safety and efficacy study, as demanded by regulators. Registry ‘big data’ can provide evidence of associations of problems. However, registries cannot provide evidence of causation.

Hence, without careful consideration of the data and its limitations, registry data are at risk of incorrectly drawn conclusions and the potential of misuse of the results. That must be guarded against.

Looking at the future, registry operators benefit from a collective experience of running registries as they mature, allowing for improvements across specialties. Large-scale registries are not only of merit, improving with stakeholder acceptance, but also are critical in furthering our understanding of our patients’ outcomes. In doing so, they are a critical element for our future scientific discourse.

  • knee injuries
  • anterior cruciate ligament
  • arthroplasty
  • replacement
  • patient outcome assessment
  • osteotomy

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Footnotes

  • Contributors All authors certify that they have participated sufficiently in the work to take public responsibility for the content. EB and MJM conceptualised and designed the work, participated in the acquisition and analysis of the data. All authors participated in interpretation of the data. EB and MJM drafted the manuscript together with NN and CL who helped editing it critically for important intellectual content. All authors gave final approval of the version to be published and agree to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.

  • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

  • Competing interests MJMcN is Chair of the ICRS Global Registry Committee and on the Steering Committee of the UK National Ligament Registry. NN is a Journal of ISAKOS Editorial Board member.

  • Provenance and peer review Commissioned; externally peer reviewed.

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