Databases created by two doctors’ groups are now tracking the success rates of artificial hips and knees in the U.S. following a Johnson & Johnson (JNJ) unit’s decision last year to recall a hip implant used on 93,000 patients.
The two registries -- one organized by the orthopedic industry and the other funded by the federal government -- will replicate and improve on national databases in Australia, Sweden and elsewhere, according to doctors leading the efforts.
DePuy Orthopaedics, a unit of New Brunswick, New Jersey- based J&J, issued a voluntary global recall of its ASR device in August after learning of heightened failure rates from data collected by the U.K.’s national joint registry. The company faces more than 1,000 lawsuits in state and federal courts by patients who had the hip implants.
“We’ve been doing a huge experiment and no one’s been keeping track of the data,” said William Maloney, vice chairman of the American Joint Replacement Registry and professor of orthopedic surgery at Stanford University School of Medicine.
The AJRR, which is funded by orthopedists, prosthetic manufacturers, insurance companies and hospitals, began collecting data from 16 hospitals in December as part of a pilot program, said its chairman, David Lewallen, a professor of orthopedic surgery at the Mayo Clinic in Rochester, Minnesota. The group plans to roll out the data collection system nationwide later this year.
The goal is to track the more than 700,000 total hip and knee replacement surgeries that take place in the U.S. each year and, over time, record which implants failed prematurely, requiring revision surgery to fix the original operation, Lewallen said.
“What we envision happening is an inch-deep, mile-wide effort across the country, where we try to get basic information and plot survivorship curves for implants, so we know when they go in and when they come out,” Lewallen said.
He said that monitoring successes and failures ultimately will save money for insurers.
“The most expensive hip is the one that has to be revised,” he said.
Lewallen said the American Joint Replacement Registry has so far secured $1.7 million in funding -- including $665,781 from the American Academy of Orthopaedic Surgeons and $783,800 from AdvaMed, the trade association that represents medical product manufacturers.
The leading hip makers behind J&J are Warsaw, Indiana-based Zimmer Holdings Inc. (ZMH) and Kalamazoo, Michigan-based Stryker Corp., according to a BMO Capital Markets report in February that said the worldwide hip replacement market would grow 3.2 percent this year from $5.28 billion in 2010. U.S. hip and knee implants account for more than half of all joint replacement procedures globally, Aarti Shetty, an analyst with Frost & Sullivan, said in an e-mail.
DePuy Supporting AJRR
Lorie Gawreluk, a spokeswoman for DePuy, said the company is supporting AJRR with technical expertise and funding through AdvaMed “to further monitor the safety and performance of these implants for the benefit of all orthopaedic patients.”
“We are pleased that the American Joint Replacement Registry has progressed to a pilot phase,” she said in an e- mail.
DePuy announced the ASR recall on Aug. 26 after 93,000 of the devices had been had been implanted in patients worldwide, including 37,000 in the U.S. The company cited unpublished 2010 data from the U.K. showing that within five years, 13 percent of its ASR XL Acetabular hips failed and needed to be replaced.
DePuy, which also makes spinal-care devices and generated $5.59 billion in revenue last year, said it withdrew the hips for safety reasons, while denying in court papers that the devices are defective.
J&J had committed $280 million to the recalls as of March 31, and has pledged to “address reasonable and customary costs associated with testing and treatment,” including new hips for patients who need them. Based on the latest estimates of failure rates, the total tab could reach billions of dollars, said Michael Kelly, a San Francisco lawyer whose firm has filed more than 70 cases on behalf of patients with the DePuy hips.
A second registry, funded with a $12 million grant from the Agency for Health Care Research and Quality, a division of the U.S. Department of Health Care and Human Services, is being run by the University of Massachusetts Medical School, according to the registry website.
The UMass registry will track the experiences of more than 30,000 patients who undergo hip or knee implants each year, said Patricia Franklin, professor of orthopedics at the university and the principal investigator behind the study. Details about the individual patient’s experience could shed light on why some implants succeed and others fail, she said.
“Our research strategy is to complement the national registries,” Franklin said. “Was the metal implant successfully implanted? If so, when was it removed? While that’s important, we believe we should collect that, plus patient assessment. Did the patient have an unusual amount of pain? You wouldn’t know that from the revision rate.”
Brian Devine, a lawyer for plaintiffs suing DePuy over hip replacements, said he has concerns about the American Joint Replacement Registry’s reliance on funding from prosthetic manufacturers, the companies whose products are being monitored.
“It’s concerning that industry is financing it,” Devine said. “We think there should be absolute independence.”
“We’ll always have naysayers,” Lewallen said when asked about the decision to include two device manufacturers on his registry’s 13-member board. “But we have the best chance of providing the best information and ability to change behavior if we have them at the table.”
AJRR board member Cheryl Blanchard, the chief scientific officer at Zimmer Holdings, said that registries in other countries, including the U.K., include manufacturers.
“It’s really not significantly different from registries that exist outside the U.S.,” she said. “We’re not trying to reinvent the wheel here.”
Blanchard and Lewallen said that in nations with single- payer health systems, it’s easier for government overseers to start joint registries by fiat. In the U.S., with its patchwork of public and private payers, it’s more complicated, and the involvement of every participant in the process, including manufacturers, is necessary, they said.
“Most of the money for this comes from industry,” said AJRR board member Bob Durgin, head of quality, regulatory and clinical affairs at Biomet Inc., an orthopedics supplier based in Warsaw, Indiana. He said AJRR aims to limit industry contributions to 50 percent of the registry’s annual budget. “People can view that support negatively, but I think it’s important in helping to maintain credibility.”
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