Rethinking analytical strategies for surveillance of medical devices: The case of hip arthroplasty Academic Article uri icon

Overview

MeSH Major

  • Arthroplasty, Replacement, Hip
  • Hip Prosthesis
  • Product Surveillance, Postmarketing

abstract

  • 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.

publication date

  • June 2010

Research

keywords

  • Academic Article

Identity

Language

  • eng

Digital Object Identifier (DOI)

  • 10.1097/MLR.0b013e3181de9cfa

PubMed ID

  • 20473192

Additional Document Info

start page

  • S58

end page

  • 67

volume

  • 48

number

  • 6 SUPPL.