Most New Devices Not Better After All? (Orthopedics This Week)
In reviewing 118 studies and 15,384 implants, researchers from the Netherlands found that none of five new devices reviewed improved functional or patient reported outcomes and that existing devices may be safer to use.
What are we doing wrong as a field? Marc Nieuwenhuijse, M.D., an orthopedic resident at the Leiden University Medical Center and ICOR research fellow, tells OTW, “Changes in the way of introduction of new orthopedic implants into the commercial market are necessary. The introduction of new orthopedic 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 recognized 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 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.”
“I was surprised at the widespread usage of these innovations without either substantial research or convincing evidence of their benefit over existing alternative device solutions for the same conditions. Recent large scale failures of the articular surface replacement and large head size metal-on-metal articulations in total hip replacement have taught us that incremental device innovations can have a large impact on implant survival and patient safety. Since none of the five selected device innovations were safer than earlier alternative devices, we believe improved regulation and professional society oversight are necessary to prevent patients from being further exposed to these and future innovations introduced without proper evidence of improved clinical efficacy and safety. The clinical introduction of implants should follow a stepwise and controlled model preventing exposure of large numbers of patients to potentially inferior new devices.”
“Improved regulation and professional society oversight are necessary to prevent adverse events. We need to find a balance between being too careful and waiting until all of the results are available. The way to do this would be to focus our research on new methods for early evaluation of implant performance. For example, I did research on radiostereometry that allowed for measurement with a high degree of accuracy (to a few tenths of a millimeter). This has predictive value for future loosening of implants. Additionally, improved surveillance through the International Consortium of Orthopedic Registries should be undertaken. Their goal of combining all registries worldwide would lead to more accurate information. For now, we suggest adherence to the IDEAL recommendations and a critical point of view regarding evidence for efficacy and safety when considering adopting new implants.”