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National Joint Replacement Registries: Has the Time Come?
William J. Maloney, MD
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William J. Maloney, MD
Department of Orthopaedic Surgery, ­Washington University School of Medicine, 660 South Euclid Avenue, Campus Box 8233, St. Louis, MO 63110. E-mail address: maloneyw@msnotes.wustl.edu

The author did not receive grants or outside funding in support of his research or preparation of this manuscript. He did not receive payments or other benefits or a commitment or agreement to provide such benefits from a commercial entity. No commercial entity paid or directed, or agreed to pay or direct, any benefits to any research fund, foundation, educational institution, or other charitable or nonprofit organization with which the author is affiliated or associated.

J Bone Joint Surg Am, 2001 Oct 01;83(10):1582-1585
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Total joint replacement surgery is widely recognized as one of the most cost-effective interventions in medicine today. The impact that these procedures have on quality of life has been well documented1. New implants are designed and manufactured with the expectation that they will be equivalent or superior to existing products. Regardless of how much testing is done prior to product release, in reality our patients are the final testing grounds for new devices. Only in our patients do all of the variables that affect outcome—that is, design issues, material issues, manufacturing issues, patient-related factors, and surgical technique—finally come into play. As a result, premature failures can and do occur.
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    Accreditation Statement
    These activities have been planned and implemented in accordance with the Essential Areas and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint sponsorship of the American Academy of Orthopaedic Surgeons and The Journal of Bone and Joint Surgery, Inc. The American Academy of Orthopaedic Surgeons is accredited by the ACCME to provide continuing medical education for physicians.
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    Richard Gelberman, MD
    Posted on October 23, 2001
    NULL
    Barnes-Jewish Hospital at Washington Univ

    Comment on "Total Joint Replacement Registries: Has the Time Come?" (JBJS October 2001) by William J. Maloney, MD; Comment by Richard Gelberman, MD

    The important article by Maloney provides a compelling argument for the development of a national registry for total hip and knee arthroplasties in the United States. It demonstrates the positive impact that such registries have had elsewhere and substantiates the need to obtain data that accurately assess the results of joint replacement in the United States.

    There are unique practical and political challenges associated with creating a national registry in our country. The cost of this initiative compels us to seek the sponsorship of the federal government rather than corporate and/or private support. In doing so, we must demonstrate that such a registry can provide important findings for improving future care so that operational costs are an investment that will be rewarded by improved outcomes, thus saving the nation's healthcare system substantial resources. While the federal government has funded other types of registries, primarily those focused on disease, there have been no registries of this type (related to surgical outcomes) or magnitude in the United States.

    There are additional challenges in the compilation and management of these data, including governance of the database and monitoring access to the data. To ensure the security and reliability of the data, processes will be developed for data control, verification, updating, and the regulated release of information. These safeguards will be of particular importance to policymakers, especially as they attempt to define those constituencies who will have, or should have, access to the data. The issue of access is of central importance to device manufacturers who have concern that these data may be used against them in liability suits.

    There are a few other concerns. There are new privacy rules that may have a negative impact on pursuing the creation of this registry. Beginning in 2003, regulations created by the U.S. Department of Health and Human Services may impose restrictions on the collection of protected medical information.

    Most ongoing registries have been developed in countries that operate a single government-operated or government-funded healthcare system. Although this is not the case in the United States, we are fortunate that there are federal agencies with missions that are consistent with the development of a national registry, particularly the Agency for Healthcare Research and Quality (AHRQ) of the Department of Health and Human Services.

    Despite the challenges that confront us, the benefits that can be realized from this effort will be enormous. Our patients and the public as a whole will be well served, and the discipline of orthopaedic surgery will be substantially advanced. I applaud the leadership of the Academy's project team, headed by Dr. Maloney, and I anticipate that they will find a way to overcome these and other obstacles to the development of a national joint registry in the United States.

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