Study Raises Questions About New Joint Implants (MedPageToday)
Innovations to devices used in joint replacement have been introduced without sufficient evidence that they are any better than existing implants, a systematic review suggested.
In fact, for one type of new device technology, hip replacements with modular femoral necks, the cumulative rates of revision surgery at 5 and 10 years were 7.4% and 10.8%, compared with rates of 3.7% and 6.4% for conventional prostheses with nonmodular necks, according to Art Sedrakyan, MD, PhD, of Weill Cornell Medical College in New York City, and colleagues.
That represented a near doubling of the adjusted 10-year revision risk (HR 1.92, 95% CI 1.76-2.10), the researchers reported online in The BMJ.
The publicity surrounding the problems associated with large-size, metal-on-metal hip replacements -- high revision rates, recalls, and lawsuits -- led to calls from the scientific and regulatory communities for greater oversight of orthopedic implants and other medical devices.
"This systematic review was part of a U.S. Food and Drug Administration-initiated project on comparative effectiveness and safety of orthopedic implants as a reaction to ...
