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Scientific Articles   |    
RSA and Registries: The Quest for Phased Introduction of New Implants
Rob G.H.H. Nelissen, MD, PhD1; Bart G. Pijls, MD1; Johan Kärrholm, MD, PhD2; Henrik Malchau, MD, PhD3; Marc J. Nieuwenhuijse, MD1; Edward R. Valstar, MSc, PhD1
1 Biomechanics and Imaging Group, Department of Orthopaedics, Leiden University Medical Center, P.O. Box 9600, 2300 RC Leiden, The Netherlands. E-mail address for R.G.H.H. Nelissen: r.g.h.h.nelissen@lumc.nl
2 Department of Orthopaedics, Sahlgrenska University Hospital, SE-431 80 Mölndal, Sweden
3 Massachusetts General Hospital, Jackson Building 1126, 55 Fruit Street, Boston, MA 02114
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Disclosure: One or more of the authors received payments or services, either directly or indirectly (i.e., via his institution), from a third party in support of an aspect of this work. In addition, one or more of the authors, or his institution, has had a financial relationship, in the thirty-six months prior to submission of this work, with an entity in the biomedical arena that could be perceived to influence or have the potential to influence what is written in this work. No author has had any other relationships, or has engaged in any other activities, that could be perceived to influence or have the potential to influence what is written in this work. The complete Disclosures of Potential Conflicts of Interest submitted by authors are always provided with the online version of the article.

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Investigation performed at Leiden University Medical Center, Leiden, The Netherlands

Copyright © 2011 by The Journal of Bone and Joint Surgery, Inc.
J Bone Joint Surg Am, 2011 Dec 21;93(Supplement 3):62-65. doi: 10.2106/JBJS.K.00907
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Abstract

Introduction: 

Although the overall survival of knee and hip prostheses at ten years averages 90%, recent problems with several hip and knee prostheses have illustrated that the orthopaedic community, industry, and regulators can still further improve patient safety. Given the early predictive properties of roentgen stereophotogrammetric analysis (RSA) and the meticulous follow-up of national joint registries, these two methods are ideal tools for such a phased clinical introduction. In this paper, we elaborate on the predictive power of RSA within a two-year follow-up after arthroplasty and its relationship to national joint registries. The association between RSA prosthesis-migration data and registry data is evaluated.

Methods: 

The five-year rate of revision of RSA-tested total knee replacements was compared with that of non-RSA-tested total knee replacements. Data were extracted from the published results of the national joint registries of Sweden, Australia, and New Zealand.

Results: 

There was a 22% to 35% reduction in the number of revisions of RSA-tested total knee replacements as compared with non-RSA-tested total knee replacements in the national joint registries. Assuming that the total cost of total knee arthroplasty is $37,000 in the United States, a 22% to 35% reduction in the number of revisions (currently close to 55,000 annually) could lead to an estimated annual savings of over $400 million to the health-care system.

Conclusion: 

The phased clinical introduction of new prostheses with two-year RSA results as a qualitative tool could lead to better patient care and could reduce the costs associated with revision total knee arthroplasty. Follow-up in registries is necessary to substantiate these results and to improve post-market surveillance.

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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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