Zimmer has supported national joint replacement registries outside of the United States for several years. As a member of AdvaMed, a trade association representing medical device manufacturers, the Company is now participating in the development of the International Consortium of Orthopaedic Registries. The FDA held a public workshop on May 9 to discuss ICOR, and Zimmer was the only industry representative that participated on the panel. Cheryl Blanchard, PhD, senior vice president and chief scientific officer for Zimmer, discusses five points on the importance of joint registries and the future of ICOR.
1. Why to support a registry. Joint replacement registries are important for orthopedic surgeons, patients and device companies because data generated from the registries can help in assessing the ongoing efficacy of a procedure or device. "It's about our ability to ensure the continued efficacy of a device and use the data from the registries to improve outcomes for patients," says Ms. Blanchard. "It's not easy to generate the data for post-market studies because you need large data sets. If you are trying to gather a large amount of data through clinical trials, it can often be difficult to secure enough participants."
Joint replacement registries collect data from a large number of sources, and the data is part of a real-world situation. Clinical trials can be beneficial, but data from the real world may be more valuable going forward.
2. Going beyond national registries. The United States doesn't currently have an official joint replacement registry, although there are some large providers who collect joint replacement data from their physicians. The American Academy of Orthopaedic Surgeons has also been involved in creating the American Joint Replacement Registry (AJRR), but data from a single country may not be enough to tackle all of the issues associated with robust post-market surveillance for joint replacements.
"The FDA is realizing that a large dataset in a given registry might not be enough to create a robust post-market study," says Ms. Blanchard. "You often have different experiences from one country to another and outcomes may vary from one country to another. Data is influenced by practice standards, training levels and geographic philosophies where a procedure is performed, as well as by the implants, and all of these can factor into outcomes."
3. Benefits of an international registry. There are multiple stakeholders who stand to benefit from the creation of an international joint replacement registry. Physicians and hospitals are able to mine their own data and compare it with others to see where they are leaders or need improvements. Device companies can also see data from their products for post-market surveillance and certification in other countries.
Patients, payors and the healthcare system also stand to benefit from national and international registries because countries participating in registries have lower revision rates. "With these registries, payors can really understand the cost/benefit ratios of these procedures, and seeing how well devices are performing can help facilitate decisions about surgery," says Ms. Blanchard. "Government entities will also benefit because Medicare has a vested interest in the performance of the devices, and so does the FDA."
4. Appropriate use for registry data. There is plenty of opportunity for different stakeholders to collaborate with ICOR on bigger datasets and harmonize the post-market surveillance requirements. "We ended the conference feeling it was feasible for us to move forward and make things happen," says Ms. Blanchard. "The FDA felt all the multiple shareholders would benefit from it."
However, there is a potential for misusing registry data. The data isn't designed for making reimbursements decisions. "Registries typically collect Level 1 data, and you can glean a lot from that data, but it's difficult to extrapolate reimbursement decisions from it," she says. "You don't know the cause of a revision or the quality of the patient's life after surgery from the given information. The data is useful for finding trends, and then building stronger studies upon it."
Additionally, one shouldn't use registry data to determine whether a device company should recall an implant, even if that implant isn't performing well. "There are multi-factorial reasons for implant results in a patient," she says. "The data just tells you when you need to look into something further and really understand it."
5. Future of ICOR. At the conference, the different stakeholders and registries got together and worked on demonstration projects to outline pitfalls associated with creating ICOR and how they might be overcome. For example, there are several information technology issues that will arise because ICOR brings together several different databases and tackling those issues could be problematic, but not impossible.
The next step will be to form a discussion around data use, and then creating data management rules, such as how long the different stakeholders will be able to see the data, before launching the registry.
Learn more about Zimmer.
Articles Related to Joint Replacement Registries:
4 Benefits of a National Joint Replacement Registry
Hospital for Special Surgery Creates Musculoskeletal Outcomes and Research Center
AAOS Creates American Joint Replacement Registry