Medicare could save as much as a $1 billion a year by tracking the failure rates of orthopedic implants and using that information to lower the incidence of revision surgeries – if the country had a system for collecting the data.

The United States, unlike Australia, Canada and a number of European nations, has no national registry for hip and knee implants.

Dr. Richard D. Coutts, a professor of orthopedic surgery at the University of California-San Diego, said lowering the surgical revision rate by 10 percent would save Medicare about $1 billion.

Need established

Coutts came to Memphis and spoke about efforts to create a registry in a recent speech sponsored by the InMotion Orthopaedic Research Center.

“The United States is the largest consumer of medical devices,” Coutts said. “I think we have an obligation to know the success and failure of these devices and, most importantly, improve patient safety and outcomes. That’s our mandate.”

In July, the nonprofit American Joint Replacement Registry was launched by the American Academy of Orthopaedic Surgeons to begin work on the project.

The Academy estimated the cost of getting a registry running at between $20 million and $25 million. Coutts said the nonprofit tasked with the job has about $1 million in initial funding.

The idea of national registry has intrigued Coutts since he heard about Sweden’s total joint registry, which was established in 1979.

“They reduced the revision rate of total hip replacement in Sweden,” he said.

Coutts cited a published study that showed Sweden’s surgical revision between 1992 and 2000 was 6.4 percent compared to 16.9 percent for Medicare during the same time frame.

The registry could also provide insight as to whether the surgeon or the implant may be at fault when an implant fails. It could compare the failure rates of ceramic and metal devices.

In January, an editorial in “The Journal of Arthroplasty” questioned the risk associated with metal-on-metal bearings. It cited data from implant registries in Australia and the United Kingdom.

Coutts gave an example of the value of a registry by noting that men appeared to have better success rates on hip resurfacing, a alternative technique to total hip replacements.

However, a closer look at the data from Australia revealed the distinguishing factor wasn’t based just on sex.

“Both men and women who had smaller femoral heads and smaller femoral necks behaved pretty much the same – higher failure rates than those who had greater than a 50 millimeter diameter head,” Coutts said. “The real message out of this is, you really shouldn’t be doing surface replacements in individuals who have small bones.”

Word is spreading

The American Academy of Orthopaedic Surgeons began formal discussions about establishing a registry in 2001 when it held a workshop. About two years later, the Academy began work on the project.

The project ran into three big barriers: cost, logistical difficulties and legal concerns. The legal issues ranged from how to comply with HIPPA privacy guidelines to concerns about a registry surfacing in malpractice suits.

Those barriers were compounded by the fact that the data vendor chosen to work on a registry prototype went out of business, Coutts said. Other factors holding up progress were a changeover in leadership at the Centers for Medicare & Medicaid Service and uncertainty about whether Congress would act to set up a registry.

Cost may be the biggest barrier.

“As far as I know, up until this point in time, we still don’t have a strategy for paying for this,” Coutts said.

The cost of the registry would be more than offset in savings if the data were used to improve patient outcomes, according to a fact sheet from the American Academy of Orthopaedic Surgeons. A 2 percent decrease in the U.S. revision rate would yield total savings of $652 million a year.

If and when a nationwide registry goes online, full participation by hospitals and surgeons will be crucial for collecting accurate data, Coutts said.

The Swedish registry indicates that individual surgeons in most cases are “the linchpin” for success or failure, he said. Besides doing the procedure, the surgeons choose the implants.

“That’s a potential barrier to having a registry because surgeons got the idea that by submitting data they, in essence, would be graded and might be told that they shouldn’t be doing surgery any longer.” he said. “That is clearly one of the goals of the registry – to identify outliers. But it is not meant to be punitive. I think it’s really important for an outlier to know that he or she is an outlier.”