title: RSA and registries: the quest for phased introduction of new implants.
abstract: BACKGROUND
  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.
  
  
  CONCLUSIONS
  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.affiliation: Biomechanics and Imaging Group, Department of Orthopaedics, Leiden University Medical Center, PO Box 9600, 2300 RC Leiden, The Netherlands. Nelissen: r.g.h.h.nelissen@lumc.nl
authors.forename: Rob G H H
authors.initials: RG
authors.lastname: Nelissen
authors.forename: Bart G
authors.initials: BG
authors.lastname: Pijls
authors.forename: Johan
authors.initials: J
authors.lastname: Kärrholm
authors.forename: Henrik
authors.initials: H
authors.lastname: Malchau
authors.forename: Marc J
authors.initials: MJ
authors.lastname: Nieuwenhuijse
authors.forename: Edward R
authors.initials: ER
authors.lastname: Valstar
mesh_terms: D019645:Arthroplasty, Replacement, Knee / Q000009:adverse effects / Q000191:economics / Q000706:statistics & numerical data*; D001315:Australia; D003362:Cost-Benefit Analysis; D019544:Equipment Failure Analysis; D006801:Humans; D007720:Knee Prosthesis / Q000009:adverse effects / Q000191:economics / Q000706:statistics & numerical data*; D009520:New Zealand; D011358:Product Surveillance, Postmarketing / Q000191:economics / Q000379:methods* / Q000706:statistics & numerical data; D011475:Prosthesis Failure; D059869:Radiostereometric Analysis / Q000191:economics / Q000592:standards; D012015:Reference Standards; D012042:Registries / Q000706:statistics & numerical data; D012086:Reoperation / Q000191:economics / Q000706:statistics & numerical data; D013548:Sweden