Abstract
Surgical implants have come under increasing scrutiny in recent years. A number of high profile failures have highlighted the importance of quality assurance and research that supports their use. Well designed clinical trials provide an objective way of assessing the effectiveness and safety in human subjects that can then be evaluated by the wider orthopaedic community. This article highlights some of the problems with current implant regulations and the stages in designing a clinical trial for an orthopaedic implant.
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