International Consortium of Orthopaedic Registries
Welcome to the International Consortium of Orthopaedic Registries.
ICOR is a U.S. Food and Drug Administration-sponsored initiative that is quickly evolving into a public-private partnership, with over 30 registries participating worldwide. Our purpose is to facilitate and enhance inter-registry collaboration through the provision of a supportive infrastructure and the development of a distributed data network that uses innovative approaches to analyze the data.
This approach is well suited to meet our goals of working with all registries, whether they are well-established or in the development stages. We also aim to assist our participating organizations with a creation of a learning network. Most importantly registries maintain control of their own data and, when they collaborate, they can contribute data in a manner that is not resource intensive.
We are currently working on three projects:
1. Development of worldwide implant (prosthesis) database
2. Comparison of various bearings used in stemmed hip replacement
3. Comparison of various fixed and mobile bearings used in knee replacement
The ICOR initiative was launched in 2011 with an inaugural conference that was held on May 9-10 at the headquarters of the FDA in Silver Spring, MD. This conference summarized the international data sources and methods for post-market evaluations and surveillance of orthopedic devices. The conference attendants included 73 stakeholders from 29 orthopaedic joint registries (total joint arthroplasty) representing 14 nations. In addition, there were over 25 non-registry stakeholders representing industry, AHRQ, NIH, CMS, academia, device regulatory agencies, device cataloguing experts insurers and payers. The meeting was the first main step to build the ICOR methodological infrastructure to evaluate orthopaedic implant safety and effectiveness.
The broad participation of national and international registries at various stages of development ensured a comprehensive approach for ICOR. All stakeholders highlighted the need to develop infrastructure to collaborate and focus on understanding the variability in outcomes of total hip (THA) and total knee (TKA) arthroplasty devices. Currently, the worldwide registries include information about more than 3,500,000 orthopaedic surgeries capturing all implantable devices on the market.
The ICOR initiative is creating one of the largest worldwide collaboration with registries and academic centers that have research and clinically relevant expertise to establish a network. The ICOR recognizes the need to leverage resources and expertise from multiple stakeholders toward the development and application of innovative methods to address data and methodological gaps in studying orthopedic devices.
There are many needs in the orthopedics that can be addressed as the consortium partnership matures. The partial list includes the following:
-Develop priorities for research that reflect the consensus of different stakeholders
-Address the impact of rapid innovations in devices
-Assist the 510(k) process for approval of orthopedic devices
-Fill the gaps in device identification while unique identifiers are developed
-Address the lack of long term safety data
-Conduct medical device research and close evidence gaps for orthopedic devices
The International Consortium of Orthopedic Registries' USA Collaboration (ICOR-USA) aims to develop a US national device surveillance network in the orthopedic device space. ICOR-USA is a collaborative effort between the FDA's MDEpiNet-Weill Cornell Medicine Science and Infrastructure Center, and orthopedic registries such as the American Joint Replacement Registry, Kaiser Permanente's Total Joint Replacement Registry, the FORCE-TJR project, and HealthEast.
The FDA's new post-market surveillance vision highlights the importance of national registries and linkages with detailed datasets such as billing or administrative claims data and other routinely collected electronic data for the creation of a national system for post-market surveillance. Total joint replacement is the fastest growing elective device based surgery in the nation, if not in the world, with over 1.2 million hip and knee replacements performed annually in the U.S. With the aging of the baby boomer generation, higher rates of osteoarthritis diagnoses, innovative treatment options, and the growing demand for improved mobility and quality of life, procedure volumes are projected to reach 3 million annually in the next two decades. The performance of thousands of hip and knee devices is the most critical device safety issue in the U.S. today.
Major evidence gaps in device performance exist and, through this project, we will capitalize on a novel partnership within the FDA's Medical Device Epidemiology Network (MDEpiNet) to build a national infrastructure and fill the gaps in evidence. Our initiative aims to bring together registries in a systematic way and obtain longer, more complete patient follow-up via data linkages. Our network will be a resource to address the safety and effectiveness of new devices as they enter routine usage. Using this data network, researchers will be able to conduct comparative effectiveness studies within a short period after their market entry. Linkages between registries and state/national claims datasets will also significantly benefit registry efforts, including validation of complications, increased follow-up rate, ability for risk adjustment, and increased information about patient characteristics. This in turn will allow the registries to better serve their contributing hospitals by providing more detailed, useful reports.
By harmonizing and linking clinical registry information from diverse registries in the orthopedic setting, we aim to share knowledge about best practices for data collection, linkages with claims and other data systems, analytics, and dissemination. Moreover, the collaboration and demonstration of the value of registries will strengthen support from stakeholders. The consortium can serve as a basis for fulfillment of pre- and post-approval requirements related to orthopedic devices.