Data sources and selected methodological issues to consider in epidemiologic studies of orthopedic medical devices

Epidemiologic research has provided much of the clinical trial data used to evaluate the efficacy and safety of orthopedic devices and to build the body of scientific knowledge we have about these devices, but the full potential of the clinical trial and other epidemiologic research designs to expand our knowledge of the long-term effectiveness of orthopedic devices and improve clinical practice has yet to be realized. This section describes data sources available for use in epidemiologic studies of orthopedic devices and some of the methodological issues researchers should consider in conducting future epidemiologic studies to address the information needs and fill the data gaps in our current understanding of the safety, efficacy, and effectiveness of orthopedic devices. This section is intended to complement the discussion presented of methodological issues common to many epidemiologic studies of medical devices.

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