National Joint Replacement Registry Pilot Program Underway

Many consider it an early warning system. Some believe it can help gauge product durability. And others are counting on its ability to assess system diversity.

The American Joint Replacement Registry (AJRR) spearheaded by the American Academy of Orthopaedic Surgeons (AAOS) symbolizes a diverse set of opportunities for a diverse industry, but the most important goal is perhaps that of patient safety. Those charged with building the registry tout its “far-reaching benefits to society, including reduced morbidity and mortality; improved patient safety, quality of care and medical decision-making; reduced medical spending; and advances in orthopedic science and bioengineering.”

Though it is still several years away from having enough data to report, the registry is nonetheless on the development fast track with its architects. Created last year in Illinois (to take advantage of the Prairie State’s strong data protection laws), the registry began collecting data from 15 hospitals in October, tracking basic details about patients, doctors, medical centers and implants. Once it is fully operational, the registry is expected to cost about $4 million annually and be funded by surgeons, implant manufacturers, payers, medical societies and industry groups. The registry has already received support from orthopedic bohemoths such as Johnson & Johnson’s DePuy Orthopaedics division, Zimmer Holdings Inc., Biomet Inc., Wright Medical Group Inc., DJO Surgical and Exactech Inc.

Organizers hope to expand the registry next summer. In the meantime, its Board of Directors must craft a strategy to address data reporting and costs. One of the ideas currently being considered is asking insurance companies and Medicare to provide financial incentives for hospitals to participate, since insurers benefit from fewer patient complications.

While many in the industry claim the registry could help identify specific problems with implants and keep recall-related costs down, some experts are concerned about accessibility to the data and the ways in which it could be used. Registries generally produce raw information rather than high-level medical evidence; such information, skeptics argue, could be taken out of context and used by insurers to limit coverage of a procedure, by patients filing lawsuits, or by companies’ marketing departments. Such concerns can be addressed by allowing doctors, hospitals and manufacturers to access data that relates only to them and is benchmarked against broader details, though no decisions have yet been made.

“The AJRR will need to put agreements into place that establish the parameters of the data sharing relationship,” said E. Anthony, Rankin, M.D., a member of the registry’s board. Rankin, a former AAOS president, currently is chief of orthopaedic surgery at Providence Hospital, a clinical professor at Howard University School of Medicine, and a clinical associate professor (community and family medicine) at Georgetown University School of Medicine—all located in Washington, D.C. He specializes in adult reconstruction and hand surgery.

“Parties to these agreements include device manufacturers, managed care organizations, government agencies and other registries,” he told AAOS Now, the academy’s monthly publication, earlier this year. Besides data sharing issues, the board also must resolve several legal issues before the registry becomes operational. One of the most important legal matters pertains to device performance, according to Rankin. Since the registry does not qualify as a reporting organization, it is not obligated to provide the U.S. Food and Drug Administration (FDA) with data that suggests an implant could seriously injure a patient. The manufacturer of that implant may be obliged to report the data, and the registry certainly can volunteer the information, but it would not be required to do so, Rankin explained.

Device performance is perhaps the most valuable piece of data the registry will collect. Tracking repeat surgeries to fix worn-out implants can help surgeons, manufacturers and medical device designers better identify and determine the durability of replacement parts. It also potentially could save the United States millions of dollars annually. According to statistics from the AJRR, 7.5 percent of the more than 1 million hip and knee replacements performed in 2006 were revision surgeries, which resulted in 77,000 procedures and cost the nation’s healthcare system a staggering $3.2 billion. A mere 2 percent reduction in revision procedures could save the health system $65.2 million in one year and more than $1.3 billion over 20 years, the AJRR estimates.

A reduction in revision procedures also could save companies millions of dollars in legal costs and stem the tide of lawsuits from patients harmed by defective implant parts and additional replacement surgeries. It also could enable companies to correct problems with devices before they balloon into full-blown recalls.

DePuy Orthopaedics could have benefited from such foresight this past summer, when the Johnson & Johnson subsidiary recalled its ASR XL Acetabular and ASR Hip Resurfacing systems due to high numbers of revision surgeries. Patients began suing the company before the recall became official, with some claiming that DePuy knew about problems with the implants but marketed them anyway. Over the last two years, the FDA has received about 400 complaints from American patients who received the implants, according to a March article in The New York Times.

Late last year, DePuy said it was phasing out the implants because of slowing sales. In March, the company warned doctors that the implants might have a high failure rate in some patients. In a letter dated March 6, DePuy told doctors that recently analyzed data from Australia suggested that the ASR had a higher-than-expected failure rate when used in traditional hip replacement on certain types of patients.