FDA Seeks International Joint Replacement Data; Is A U.S. Registry In Sight?
Full article reprinted from "The Gray Sheet" - April 13, 2009
Find out how FDA is looking to tap into international joint replacement device registry data to study the long-term safety and effectiveness of artificial hips, knees, ankles and other joints.
The agency posted a request for collaborators on the Federal Business Opportunities government contracting database March 31 and updated the posting April 8.
Specifically, FDA is interested in collaborating with outside-U.S. registries that are collecting "extensive" data on joint replacement devices and have at least an 80% response rate and a minimum of 1,000 participants followed for at least five years.
The registries should track all artificial joint replacements, demographic characteristics, device characteristics, survival information, revision rates, adverse events and short- and long-term outcomes, the FBO notice states.
With the help of its international counterparts, FDA's device center plans to conduct its own analysis of implant duration, survival, adverse events and revision rates.
The agency says the proposed study would yield valid estimates of device performance that "would benefit decision-making of patients, clinicians and CDRH."
Results will be shared among FDA and participating institutions, and later presented at orthopedic meetings and published in peer-reviewed journals.
Offers to participate are due May 1, and the project is expected to take place between June 1, 2009 and May 31, 2010.
Efforts Continue Toward U.S. Joint Registry
The move underscores the need for a national joint replacement registry in the United States, according to orthopedic surgeon John Kirkpatrick.
"The institution of a registry would be a huge impact in making sure we catch the odd things that do slip through the normal safeguards," said Kirkpatrick, representing the American Academy of Orthopedic Surgeons in an interview. The physician also has served on FDA's Orthopedic and Rehabilitation Devices advisory committee.
FDA's solicitation of international data is a step toward better joint replacement safety and a sign of support for a future U.S. registry, Kirkpatrick suggested. "FDA is telling people they would really appreciate this kind of a database," and the effort could stimulate development of a domestic registry, he said.
"I think they're trying to find creative ways to get as much information as they can to ensure the safety and efficacy of what's out there."
The American Academy of Orthopedic Surgeons, among others, has been advocating the creation of a U.S. joint replacement registry for about a decade, Kirkpatrick noted. Overseas, national registries already exist in the U.K., Australia and Sweden, the academy points out.
A U.S. registry could help surgeons more easily identify well-performing and sub-par implants, for example, and provide more timely data that could improve patient outcomes and save health care costs down the line, members of AAOS suggest.
Unfortunately, "getting that done in the United States in our current health care system is a challenge," Kirkpatrick said, though the effort remains a "high priority" for AAOS.
FDA's proposed study of international data builds on efforts initiated last fall, funded under FDA's Sentinel Initiative, to link organizations with information on orthopedic joint implants.
In autumn 2008 the agency sought registries with at least 300 participants followed at least one year. Hip and knee replacements, hip resurfacing products, spinal disc implants and ankle devices were among the implants of interest (1"The Gray Sheet" Aug. 11, 2008, In Brief).
- Jessica Bylander
Sign up for your 30-day, risk-free trial of "The Gray Sheet" today.
"The Gray Sheet" gives you 51 issues per year filled with useful articles that will help you meet your business and regulatory objectives.
