News and Highlights
Five newer and widely used types of hip and knee implants offer no improvement over older versions and might even require more revisions, according to a study by an international research team led by Art Sedrakyan, MD, PhD, Associate Professor of Healthcare Policy and Research and Director of the Comparative Effectiveness Program of Weill Cornell Medical College. The study was initiated by the FDA and published in the British Medical Journal (BMJ).
Using data from 118 studies, the researchers examined the efficacy and safety of five more recently developed types of implants: ceramic-on-ceramic bearings, modular femoral necks, and uncemented monoblock (not metal-on-metal) acetabular cups in total hip replacement, and high-flexion implants and sex-specific implants in total knee replacement. The study included data from clinical trials and observational studies involving 15,384 implants in 13,164 patients, as well as data from national joint registries.
None of the newer devices were found to improve functional or patient-reported outcomes, compared to older versions. Furthermore, there were higher rates of repeat surgery (revisions) associated with three of the new devices (ceramic-on-ceramic bearings, modular femoral necks, and high-flexion implants), used in hip and knee replacement surgery.
The authors say their findings suggest that "widespread and ongoing dissemination of these technologies cannot be justified from an evidence based perspective." They call for improved stakeholder oversight to prevent patients from being further exposed to new devices “without proper evidence of improved clinical benefits and safety.”
Posted September 10, 2014
- Appraisal of evidence base for introduction of new implants in hip and knee replacement: a systematic review of five widely used device technologies BMJ 2014;349:g5133
- Regulating incremental innovation in medical devices (accompanying editorial) BMJ 2014;349:g5303
- No convincing evidence to support use of new hip and knee implants BMJ press release September 9, 2014
- The BMJ Today: Medical device regulation – still out of joint BMJ blog September 10, 2014
- Efficacy and Safety of Newer Hip and Knee Implants Called into Question NEJM Journal Watch September 10, 2014
- Too little research supports newer joint implants: study
Reuters September 25, 2014
- Study Raises Questions About New Joint Implants (Medpage Today, September 10, 2014)
- New Joint Implants Had No Proven Benefit Over Older Ones (Daily Rx, September 10, 2014)
- Efficacy of Implantable Devices for Joint Replacement Questioned (MPR, September 10, 2014)
- Evidence to Support Use of New Hip and Knee Implants is Not Convincing (MedIndia, September 11, 2014
- New Study on Implants Calls for Stricter Regulations (emdt, September 11, 2014)
- Newer Joint Pain Devices May Not be Beneficial (News on Wellness, September 11, 2014)
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