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Home/Large Joints and Extremities/About Time! International Registry to Monitor Implants
Large Joints and Extremities

About Time! International Registry to Monitor Implants

January 13, 2015 1 min read Premium comments

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About Time! International Registry to Monitor Implants
Source: Wikimedia commons and Daniel Mietchen
Secondary

The identifying initials are ICOR and they stand for International Consortium of Orthopedic Registries—a new and somewhat unprecedented collaboration among researchers. Purpose of the registry is to track the effectiveness and safety of hip and knee implants after they have been installed. The researchers and data collectors are from the U.S. institutions Kaiser Permanente and Weill Cornell Medical College and registries in Australia, Spain, Italy, Sweden, and Norway.

From the perspective of consumers, it is about time.

“In orthopedics, large registries or networks of registries capture device information on a very detailed level and can become particularly important for active surveillance and post-market evaluation, ” said Art Sedrakyan, M.D., Ph.D., associate professor of health care policy and research at Weill Cornell Medical College. “Comparative studies of hip and knee devices illustrate the ability of a registry consortium to determine real-world evidence for various classes of devices and help surgeons and patients to make evidence-based choices.”

According to a report by PR Newswire, prior research had found that almost no electronic health record system can automatically identify devices and link them to an individual patient’s outcome data—but registries can. Because of this, the FDA has made the development of device registries and the creation of a device identification (UDI) system for medical devices a key priority.

“ICOR’s achievements to date have enormous implications for medical device post-market surveillance system development in the United States and worldwide, ” said Liz Paxton, director of Kaiser Permanente’s Surgical Outcomes and Analysis Unit of Clinical Analysis. “Its ability to create an international, distributed research network in the field of medical devices opens a new door for evidence development and device-safety investigations, ” she told PR Newswire.

Author

BW
Biloine W. Young
React:

Discussion

14
DS
Dr. Sarah MitchellOrthopedic Surgeon · Mayo Clinic

This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?

8
JT
James Thornton, MDSpine Fellow · HSS

Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.

5
RP
R. PatelSports Medicine · Stanford

We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.

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