The Open Spine Journal

2013, 5 : 1-5
Published online 2013 August 23. DOI: 10.2174/18765327001305010001
Publisher ID: TOSPINEJ-5-1

Clinical Trials for New Implants in Spinal Surgery. The Oxford Experience

D. Rolton , C. Thakar and C. Nnadi
Nuffield Orthopaedic Centre, Windmill Road, Oxford, UK.

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.

Keywords:

Clinical Trial, Implants, Spinal Surgery.