Recent failure of metal-on-metal bearing surfaces utilized in total hip replacement has once again led to renewed interest in joint replacement registries. The current mechanisms that are in place to monitor hip and knee device performance are clearly inadequate and do not serve the interest of patients, surgeons, or device manufacturers. Failure to adequately monitor implant performance and provide feedback to surgeons and hospitals is unfortunately not a new problem. There was widespread discussion of this issue after the Sulzer hip replacement recall (December 2000), leading Kenneth Chang from The New York Times to write “No one keeps complete track of who has what.”1 Unfortunately, not much has changed since that time. As the great philosopher Yogi Berra once said, “It's like déjà vu, all over again.”
It was clear then and it is clear now that we need high-quality, real-time data to identify poorly performing technologies and techniques. Institutional registries continue to exist; however, they are not designed to tell us what is happening in real time or in the orthopaedic community at large. National registries like the Australian National Joint Replacement Registry are more useful at identifying performance outliers in real time. Recognizing this fact, and acknowledging that there is a lack of credible data in the United States, the U.S. Food and Drug Administration (FDA) organized the International Consortium of Orthopaedic Registries (ICOR). An organizational meeting was held in May of this year and included representatives from twenty-seven orthopaedic registries from fourteen nations as well as stakeholders from other federal agencies and payers. Along with this editorial, thirteen manuscripts from presentations at that meeting are being published as an online supplement to this issue of The Journal of Bone and Joint Surgery (American Volume). The range of topics covered were broad and serve to point out the value of registries as well as the complexities of data collection, classification, and tracking of devices and data analysis.
If successful, ICOR will undoubtedly provide valuable new information gained from the pooling of data from around the world. However, it would be a mistake (in my opinion), to think that ICOR would be a substitute for a well-functioning national registry in the U.S. Implant technologies used in the U.S. are not necessarily the same as those available in other countries. Variation in surgical training, indications for joint replacement, patient disease, and the expectations of patients vary markedly from country to country. The data are simply not generalizable from one surgeon to the next, one hospital to the next, or one country to the next—a lesson the FDA certainly learned with hip resurfacing in the U.S. Although a collaborative effort such as ICOR may also serve in some instances to satisfy the postmarket surveillance requirements mandated by the FDA, it will not be able to provide the feedback to surgeons and hospitals nationwide on their own performance or enable peer-to-peer comparison. As has been emphasized by the Swedish Hip Arthroplasty Register for years, direct feedback to hospitals and surgeons on their own performance was the most important factor in improving outcomes and reducing the revision burden.
To accomplish the goal of improving patient outcomes in the U.S., a national registry must be developed. To that end, the American Joint Replacement Registry (AJRR) was established in 2010. A pilot project was completed in June of 2011, and widespread data collection will begin later this year. Success is certainly not guaranteed, but if the AJRR fails it will not be because of a lack of support or effort by orthopaedic surgeons or device manufacturers. The American Academy of Orthopaedic Surgeons, the American Association of Hip and Knee Surgeons, The Knee Society, and The Hip Society have all supported the AJRR in principle and have contributed financially as well as with human capital. Similarly, orthopaedic device manufacturers have been supportive of the goals of the AJRR and have contributed financially to its operations. Substantial barriers still exist. Devices remain difficult to track. Health Insurance Portability and Accountability Act (HIPAA) regulations and the sharing of patient identifiable information require a business service agreement (BSA) between each institution and the AJRR. Lack of clarity around HIPAA and other regulations has led some institutions to opt out of participation in the AJRR at this time or require modifications of the BSA. In addition, there are already substantial requirements on hospitals to collect data (often unfunded mandates). The ICOR concept is laudable, and I personally support the effort. However, it would be a shame if it distracts the FDA and others from what is truly needed at this time in the U.S.: real-time data on implant technology and surgical technique done by U.S. surgeons on U.S. patients.
1. Chang K. When medical devices fail in the body. 2001 Aug 7. http://www.nytimes.com/2001/08/07/science/when-medical-devices-fail-in-the-body.html
. Accessed 2011 Sep 17.