How best to regulate new implants in the market—is radiostereometric analysis enough?

Abstract

The demands of the modern patient, both in terms of what a hip replacement will allow them to do as well as for how long it will last, mean that pre-market testing and close surveillance should be robust to avoid the problems of previous implants. Implants that fail in the short-term are relatively easy to detect. Implants that fail in the medium to long-term, but sooner or in more damaging modes than their peers, are much more difficult to identify. What would be the optimal strategy to evaluate a new implant prior to release if time and resource was unlimited? Would the new implant only be released to all surgeons after careful introduction in a small cohort with detailed assessment and extended follow-up? How long is sufficient follow-up?