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RSA and Registries: The Quest for Phased Introduction of New Implants.
MedLine Citation:
PMID:  22262426     Owner:  NLM     Status:  In-Data-Review    
Abstract/OtherAbstract:
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.
Authors:
Rob G H H Nelissen; Bart G Pijls; Johan Kärrholm; Henrik Malchau; Marc J Nieuwenhuijse; Edward R Valstar
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  The Journal of bone and joint surgery. American volume     Volume:  93 Suppl 3     ISSN:  1535-1386     ISO Abbreviation:  J Bone Joint Surg Am     Publication Date:  2011 Dec 
Date Detail:
Created Date:  2012-01-20     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  0014030     Medline TA:  J Bone Joint Surg Am     Country:  United States    
Other Details:
Languages:  eng     Pagination:  62-5     Citation Subset:  AIM; IM    
Affiliation:
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.
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