Wednesday, May 4, 2011

Medical Groups Tracking Hip, Knee Implants After J&J Depuy Recall (excerpts)

By Greg Farrell
May 3 (Bloomberg) -- 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 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.
 “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.
‘Survivorship Curves’
“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.
 “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. 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.
Testing, Treatment
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.
UMass Registry
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.”

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