MedicalResearch.com Interview with: Marc Nieuwenhuijse MD Research fellow ICOR and FDA Weill Cornell Medical College New York City   Medical Research: Why did you decide to study this topic? Dr. Nieuwenhuijse : The introduction of new orthopaedic implants and related technologies has been the focus of major scientific and policy discussions since the failures of articular surface replacement and large head size metal-on-metal articulations in total hip replacement were brought to light. However, scientists and policy makers seem to “run out of steam,” and the momentum for change generated by these recent high profile failures is waning. The consequences of uncontrolled device introduction worldwide may not be fully recognised by the scientific community and there is a high likelihood that current practice regarding device innovations will not change much. As such, there is a need to investigate whether the problems associated with the articular surface replacement and large head size metal-on-metal articulation are isolated events or if there is a systemic problem affecting the introduction of a much wider range of implantable devices. In this study, we systematically evaluate the evidence concerning the introduction of five substantial, innovative, relatively recent, and already widely implemented device technologies used in major total joint replacement to determine the evidence of effectiveness and safety for introduction of five recent and ostensibly high value implantable devices in major joint replacement to illustrate the need for change and inform guidance on evidence based introduction of new implants into healthcare. (more…)