Journal of Bone and Joint Surgery, Vol 96, Issue Supplement 1

Journal Journal of Bone & Joint Surgery, Vol 96. Supplement 1 – International Consortium of Orthopedic Registries
Authors Multiple
Year Published 2014
Link to Publication

List of 14 Articles

  • National and International Postmarket Research and Surveillance Implementation: Achievements of the International Consortium of Orthopaedic Registries Initiative
  • A Distributed Health Data Network Analysis of Survival Outcomes: The International Consortium of Orthopaedic Registries Perspective
  • Effect of Femoral Head Size on Metal-on-HXLPE Hip Arthroplasty Outcome in a Combined Analysis of Six National and Regional Registries
  • Risk of Revision Following Total Hip Arthroplasty: Metal-on-Conventional Polyethylene Compared with Metal-on-Highly Cross-Linked Polyethylene Bearing Surfaces: International Results from Six Registries
  • Distributed Analysis of Hip Implants Using Six National and Regional Registries: Comparing Metal-on-Metal with Metal-on-Highly Cross-Linked Polyethylene Bearings in Cementless Total Hip Arthroplasty in Young Patients
  • Comparative Effectiveness of Ceramic-on-Ceramic Implants in Stemmed Hip Replacement: A Multinational Study of Six National and Regional Registries
  • Multinational Comprehensive Evaluation of the Fixation Method Used in Hip Replacement: Interaction with Age in Context
  • International Comparative Evaluation of Knee Replacement with Fixed or Mobile Non-Posterior-Stabilized Implants
  • International Comparative Evaluation of Knee Replacement with Fixed or Mobile-Bearing Posterior-Stabilized Prostheses
  • International Comparative Evaluation of Fixed-Bearing Non-Posterior-Stabilized and Posterior-Stabilized Total Knee Replacements
  • Survivorship of Hip and Knee Implants in Pediatric and Young Adult Populations
  • Which Implant Should We Use for Primary Total Hip Replacement?: A Systematic Review and Meta-Analysis
  • Review of Clinical Outcomes-Based Anchors of Minimum Clinically Important Differences in Hip and Knee Registry-Based Reports and Publications
  • Implementation of Patient-Reported Outcome Measures in U.S. Total Joint Replacement Registries: Rationale, Status, and Plans

Rethinking analytical strategies for surveillance of medical devices: the case of hip arthroplasty

Journal Medical Care
Authors Normand SL; Marinac-Dabic D; Sedrakyan A; Kaczmarek R
Year Published 2010
Link to Publication – (PDF)

Background

Randomized trials that sometimes serve as the basis for device approval are small, short term, and generalizable to an increasingly smaller percentage of patients. Some of the most common and challenging devices are those used in hip replacement. Artificial hips are implanted in thousands to alleviate pain caused by noninflammatory joint disease and to restore patient mobility. During 2004 in the United States, although 68% of hospital stays for partial or total hip replacements were for those aged 65 years and older, younger patients will account for 52% by 2030.

Methods

Using hierarchical modeling, we propose a framework for combining information from premarket and postmarket settings. Our key assumption is that device performance characteristics and outcomes obtained from 1 cohort are related to device characteristics and outcomes of the same or similar devices observed in other cohorts. We illustrate methods by jointly modeling Harris Hip Scores (HHSs) and revision-success data from 1851 subjects who participated in 3 pivotal randomized or observational studies of artificial hips.

Results and Conclusions

Subjects participating in randomized studies had better 2-year HHS than those in observational studies (posterior mean increase in HHS = 4.1, posterior standard deviation = 0.6). Patients implanted with ceramic-on-polyethylene hip used in 1 study had higher 2-year HHS than those implanted with a different ceramic-on-polyethylene hip in another study (mean difference = 4.2, standard deviation = 0.6). Our approach is feasible and will advance regulatory science using a transparent and dynamic new paradigm for knowledge management throughout the total product life cycle.