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U.S. orthopedists are waiting for the institution of a national joint registry
Registry advocate predicts primary THRs will double by 2026, TKR cases will double by 2016.
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With the Swedish National Joint Registry nearing its third decade and the establishment of newer registries in other countries, some orthopedic surgeons in the United States are eagerly awaiting implementation of a national joint registry here.
“Right now we’re in the stage of waiting for the government to interpret the patient safety organization legislation that was passed more than 2 years ago,” William J. Maloney, MD, said during his presentation at Orthopedics Today Hawaii 2008.
Once the Agency for Health Care Research and Quality determines how the law should be implemented, the American Academy of Orthopaedic Surgeons currently plans to form a patient safety organization and fund a pilot joint registry, Maloney said.
“The advantages of a registry are many,” he said. “You can pool patients, provide contemporary information and do postmarket surveillance. It can lead to evidence-based practice, generate research questions and be, in and of itself, a research tool.”
Procedure volume
Maloney said the sheer volume of total hip replacements (THRs) and total knee replacements (TKRs) performed annually in the United States justifies the costs of setting up a registry. Medicare data indicate that nearly 155,000 TKRs were performed in 2000, and that figure doubled by 2007.
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“Hip and knee replacement is the No. 1 expenditure of the Medicare program on health care,” he said. In separate research, Steven M. Kurtz, MD, also predicted that primary THRs and TKRs would double in the United States by 2026 and 2016, respectively, Maloney said.
Hip data from the 1990s show a revision burden of 18%, which has held steady. “We do not have the most recent years’ numbers, but our hypothesis is that with minimally invasive surgery, it is actually closer to 20%,” he said.
“An early warning system”
“There’s no effective mechanism to provide outcomes in a timely fashion,” Maloney noted. “Registries can serve as an early warning system. They influence behavior — that’s clear — and they can decrease the revision burden.”
Maloney cited DePuy’s Hylamer liners as an example in which a registry could have detected early implant problems, causing market removal in 2 years rather than 10.
“You get a better chance of getting a letter from your car manufacturer if your car is recalled than you do if you’re hip has been recalled,” he said. “Most of the recalls are driven by the company, and the FDA is essentially ineffective in this arena.”
Case evaluations not optimal
While researchers use case evaluations and randomized control trials to gain information on outcomes, these methods may be ineffective for total joint replacement. Case evaluations offer retrospective data.
“They represent the expert and innovator’s experience and you can’t compare between series very well,” Maloney said. “It’s not relevant to a community practice, and they’re not reported in a timely fashion.”
An unpublished review of nearly 87,000 THRs entered into a Medicare database noted a 5.2% revision rate at 48 months postop.
“What happens at the high-volume center in the innovator’s hands is not what happens in the community,” he said. While randomized control trials represent the gold standard in testing, there are hundreds of Food and Drug Administration-approved hip implants, making Level I trials for all of them impossible.
Medical device reports
The FDA has medical device reports. However, Maloney said that the reports often contain poor information on few implants.
“You can’t figure out why they failed,” he said. “So, this is really a waste of time as it relates to providing any service to us as surgeons or for our patients.”
Having data can also influence behavior. Swedish registry data showed more than 10% cumulative aseptic loosening for THRs in 1979, which dropped to 4.3% just 8 years later, he said. Registry data stratified by variables such as age can also help surgeons develop better patient indications.
“It’s also a very powerful tool for separating the impact of technology vs. the impact of a technically challenging prosthesis to implant on overall survival,” Maloney said.
For more information:
- William J. Maloney, MD, Elsback-Richards Professor and chair of the department of orthopedic surgery at Stanford University School of Medicine, can be reached at 300 Pasteur Drive, Edwards R109, Stanford, CA 94305; 650-723-1690; e-mail: wmaloney@stanford.edu. He has received royalties from Zimmer.
Reference:
- Maloney WJ. Joint registry update. Presented at Orthopedics Today Hawaii 2008. Jan. 13-16, 2008. Lahaina, Maui, Hawaii.