By JON KAMP
An effort to track hundreds of thousands of replacement hip and knee surgeries across the U.S. each year will soon start gathering data, with the potential to uncover implant problems more quickly.
That could eventually mean more recalls in a $12 billion industry led by companies includingZimmer Holdings Inc., Johnson & Johnson and Stryker Corp. Still, manufacturers are backing the “American Joint Replacement Registry” and have chipped in start-up funding.
By joining voluntarily and influencing development, manufacturers may dodge having to face mandated rules down the road. They’ll gain product-durability insight that could help as new, higher-priced devices need to be justified by comparative-effectiveness testing.
And the data collected by the registry could identify problems before recall-related costs balloon.
The registry “really can serve as a very robust early warning system,” said Cheryl Blanchard, chief scientific officer at Zimmer and a member of the new joint registry’s board.
Knee and hip replacement devices are approved by the Food and Drug Administration. But currently there is no big nationwide registry tracking long-term results for patients who have received the implants. By tracking when patients need repeat surgery to fix worn-out joints, the registry hopes to catch cases where parts wear out prematurely due to problems such as implant loosening or dislocation.
J&J recalled hip parts in August after a U.K. registry uncovered high repeat-surgery rates, and a Kaiser Permanente registry for its health system has played a role in several recalls. If the new registry reaches its goal of covering 90% of 5,000 U.S. hospitals that do joint surgery, it could be bigger than all other registries combined, dramatically expanding the surveillance net.
The project, an offshoot from the American Academy of Orthopaedic Surgeons, will get underway as a pilot program involving 15 hospitals this month. Initially it will track basic details about patients, doctors, hospitals and implants. The goal is for results to spur changes that improve patient outcomes.
The registry aims to start expanding next summer. In the meantime, registry officials are sorting out details about how hospitals will report data and who pays the costs. One idea is to ask insurance companies and Medicare to provide financial incentives for hospitals to participate, because insurers benefit from fewer patient complications.
Other countries, including Sweden and Australia, have well-regarded national registries. But it’s been difficult to launch a broad orthopedic registry in the complicated U.S. system. “It’s hard to herd the cats and get everybody moving in the same direction,” said David Lewallen, a Mayo Clinic surgeon who chairs the new registry’s board.
Another problem is that “most of the profession doesn’t want a registry,” said Jeffrey Lerner, chief executive of the ECRI Institute, a nonprofit research organization. Doctors and manufacturers fear possible repercussions from dredging up problems that could hurt business, he said.
Some experts also are concerned about who will have access to the data collected and how it will be used. Registries don’t produce high-level medical evidence but instead generate raw information that can signal issues that require follow-up. The worry is that information could be wielded by insurers seeking to limit coverage, or in lawsuits and marketing efforts, without appropriate context.
Details are still being worked out, but addressing such concerns may mean allowing doctors, hospitals and manufacturers to see only data that relates to them, benchmarked against broader details.
The nonprofit registry is incorporated in Illinois, which has strong data-protection laws, Dr. Blanchard said. It also will produce detailed annual reports, Dr. Lewallen said.