Is Hip Resurfacing Ready for the US Market?
In the wake of Smith & Nephew’s hip resurfacing system’s FDA approval and because the successful introduction of this technology might boost the earnings of the manufacturers which market it, TheStreet.com is looking at a number of strings attached to the technology. This article mentions the case of Beth Soltero, a medical researcher who had to have her metal on metal hip replaced less than five years after it was first used on her. She found relatively scarce data about the success rate of hip resurfacing implants over the long term. They account for roughly five to ten percent of primary hip arthroplasties performed in countries such as Australia and the United Kingdom, but this increased popularity is still quite recent so there’s a dearth of long-term studies.
In a November 2004 article for the Canadian Orthopaedic Association, Steven J.M. MacDonald noted at the time that clinical results to date had been mixed. Data from the Australian Orthopaedic Association (AOA)’s Joint Replacement Registry has the highest rates of early component revision for resurfacing implants. Dr. Joshua Jacobs, an orthopedics professor at Rush University Medical Center in Chicago, is conducting ongoing study on the materials used for prosthetic devices used in hip and knee replacement surgery. He’s advocating that the US puts in place a national joint registry like many other industrialized countries to ease the gathering of post-operation outcomes. Besides Australia, countries such the United Kingdom, New Zealand or Sweden have set up such registries. William J. Maloney, MD, wrote this article in favor of establishing one in America in the Journal of Bone and Joint Surgery five years ago. The American Academy of Orthopaedic Surgeons (AAOS) launched a pilot project named the American Joint Replacement Registry (AJRR) in March 2004. A similar experiment dubbed the North American Outcomes Registry for Total Hip and Knee Replacement (NAOR) ran in the US and Canada from 1995 to 2002 but failed to keep momentum as surgeons failed to systematically document patient cases.
06/14/2006 update: America’s first patient.
June 7, 2006 Related topics: Product Approval & Certification, Quality, Safety, Errors, Surgery, Orthopedic