title: Can physical joint simulators be used to anticipate clinical wear problems of new joint replacement implants prior to market release?
abstract: One of the most important mandates of physical joint simulators is to provide test results that allow the implant manufacturer to anticipate and perhaps avoid clinical wear problems with their new products. This is best done before market release. This study gives four steps to follow in conducting such wear simulator testing. Two major examples involving hip wear simulators are discussed in which attempts had been made to predict clinical wear performance prior to market release. The second one, involving the DePuy ASR implant systems, is chosen for more extensive treatment by making it an illustrative example to explore whether wear simulator testing can anticipate clinical wear problems. It is concluded that hip wear simulator testing did provide data in the academic literature that indicated some risk of clinical wear problems prior to market release of the ASR implant systems. This supports the idea that physical joint simulators have an important role in the pre-market testing of new joint replacement implants.
authors.affiliation: Department of Mechanical and Mechatronics Engineering, University of Waterloo, Waterloo, ON, Canada jbmedley@uwaterloo.ca.
authors.forename: John B
authors.initials: JB
authors.lastname: Medley
mesh_terms: D019544:Equipment Failure Analysis / Q000379:methods*; D006622:Hip Prosthesis; D006801:Humans; D008422:Materials Testing; D008954:Models, Biological; D011474:Prosthesis Design
keywords: Hip wear simulator; clinical wear; correlation of wear rates; metal-on-metal hip implants; pre-market testing