Editorial Commentary


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

Benjamin Kendrick, Antony Palmer, Adrian Taylor

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?

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