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Mapping existing hip and knee replacement registries in Europe

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  • Lübbeke, A.
  • Silman, A.J.
  • Barea, C.
  • Prieto-Alhambra, D.
  • Carr, A.J.

Abstract

The general shortage of evidence regarding benefits and harms of medical devices has been highlighted following the serious safety concerns with metal-on-metal hip replacements and silicone breast implants and was again pointed out in a recent survey of European Health Technology Assessment institutions. In this context the new European medical device regulation will enforce post-marketing surveillance of existing and new implants. The usefulness of registry data as a source of information for medical device real-world clinical performance and safety has been demonstrated. However, these data might be under-used by researchers and policy makers. One reason for this is the insufficient awareness of their existence. The aim of this review is to provide information to relevant stakeholders on the extent and breadth of the data currently collected in European joint replacement registries. We identified 24 registries, most of them of national coverage. Total numbers of primary total hip and knee replacements included were over 3.1 and 2.5 million records, respectively. The current focus of these registries is on whole-lifespan implant surveillance via revision rate monitoring, quality assessment of surgical and perioperative care, and hospital performance assessment. More recently, national and international comparison and benchmarking have increasingly become part of their endeavors.

Suggested Citation

  • Lübbeke, A. & Silman, A.J. & Barea, C. & Prieto-Alhambra, D. & Carr, A.J., 2018. "Mapping existing hip and knee replacement registries in Europe," Health Policy, Elsevier, vol. 122(5), pages 548-557.
    • Handle: RePEc:eee:hepoli:v:122:y:2018:i:5:p:548-557
    DOI: 10.1016/j.healthpol.2018.03.010
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    References listed on IDEAS

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    1. Niederländer, Charlotte & Wahlster, Philip & Kriza, Christine & Kolominsky-Rabas, Peter, 2013. "Registries of implantable medical devices in Europe," Health Policy, Elsevier, vol. 113(1), pages 20-37.
    2. Black, Nick & Tan, Stefanie, 2013. "Use of national clinical databases for informing and for evaluating health care policies," Health Policy, Elsevier, vol. 109(2), pages 131-136.
    3. Campillo-Artero, Carlos, 2013. "A full-fledged overhaul is needed for a risk and value-based regulation of medical devices in Europe," Health Policy, Elsevier, vol. 113(1), pages 38-44.
    4. Fuchs, Sabine & Olberg, Britta & Panteli, Dimitra & Perleth, Matthias & Busse, Reinhard, 2017. "HTA of medical devices: Challenges and ideas for the future from a European perspective," Health Policy, Elsevier, vol. 121(3), pages 215-229.
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    Cited by:

    1. Thomas V Perneger & Didier Hannouche & Hermès H Miozzari & Anne Lübbeke, 2019. "Symptoms of osteoarthritis influence mental and physical health differently before and after joint replacement surgery: A prospective study," PLOS ONE, Public Library of Science, vol. 14(6), pages 1-13, June.
    2. Jeffrey K. Aronson & Carl Heneghan & Robin E. Ferner, 2020. "Medical Devices: Definition, Classification, and Regulatory Implications," Drug Safety, Springer, vol. 43(2), pages 83-93, February.

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