The International Consortium of Orthopedic Registries’ USA Collaboration (ICOR-USA) aims to develop a U.S. 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.
Kaiser Permanente (KP) is a partner within the MDEpiNet Science & Infrastructure Center, and boasts several inter-regional implant registries that capture patient demographics, implant characteristics, surgical techniques, and outcomes, including a variety of orthopaedic devices/surgeries such as total knee/hip, anterior cruciate ligament (ACL), spine, shoulder, and hip fracture. The device registries were developed to address recall situations, disseminate best practices, identify patients at risk for failure and assess clinical effectiveness of total joint replacement implants. In addition to the inter-regional implant registries, KP also has the world’s largest private sector EHRs, KP HealthConnect®. Interconnection of all patient encounters within the EHR allows extraction of laboratory, procedural, diagnostic, pharmacy, and hospital encounters for all members in every patient care setting across KP’s regions. These data supplement inter-regional implant registries and provide a foundation for longitudinal assessment of medical devices.
The American Joint Replacement Registry (AJRR) is the national clinical data registry for total joint replacement that was certified by the Centers for Medicare & Medicaid Services (CMS) as a Qualified Clinical Data Registry in 2014. Founded in 2009 as a supporting organization of the American Academy of Orthopaedic Surgeons (AAOS), AJRR became an independent not-for-profit 501(c)3 organization in January, 2015. AJRR is a multi-stakeholder initiative and also owns and manages the California Joint Replacement Registry (CJRR). As of August 15, 2016, AJRR enrolled 794 hospitals from all 50 states. As of 2016, nearly 500,000 procedures have been submitted to AJRR, recent year corresponding to approximately 18% of the annual procedural volume in the U.S. AJRR’s procedural dataset includes information from other large institutional registries, such as HealthEast Joint Replacement Registry, the Connecticut Joint Replacement Institute, and the Harris Orthopaedic Lab at Massachusetts General Hospital. It includes as participants 9 of the top 10 orthopaedic hospitals, as ranked by US News and World Report.
The Department of Healthcare Policy and Research at Weill Cornell Medicine (WCM) is home to MDEpiNet’s Science and Infrastructure Center. It was previously a home to Agency for Healthcare Research and Quality (AHRQ)-funded Center for Education and Research on Therapeutics (CERT) focused on medical devices. WCMC and the partners in this effort provide a robust platform for large-scale research and surveillance efforts. Dr. Sedrakyan, the principal investigator, has extensive experience in medical device research and supervision. He worked at AHRQ and FDA, and supervised many large grants and contracts including the CERT program. He is the lead for the MDEpiNet Science and Infrastructure Center and patient-centered comparative research team at WCM.
MDEpiNet Public Private Partnership is a voluntary organization within the FDA’s Center for Devices and Radiological Health (CDRH) which is working to build a national medical device evaluation system bybringing together leadership, expertise, and resources to build and operate a national device ecosystem supporting the development, regulation, and use of innovative medical devices. The MDEpiNet initiative was launched under the leadership of Dr. Danica Marinac-Dabic, who serves as the Director of the Division of Epidemiology within the CDRH. Dr. Marinac-Dabic has years of experience in medical device regulatory science, particularly in the area of safety and effectiveness in the post-market setting.
The Function and Outcomes Research for Comparative Effectiveness in Total Joint Replacement (FORCE-TJR) registry, created and managed by University of Massachusetts Medical School’s Department of Orthopaedics, collects and analyzes comprehensive post-TJR data on more than 24,000 patients treated by a diverse and representative group of surgeons, and hospitals in 24 states (urban and rural, academic and community hospitals, low and high volume practices) to date. Patient enrollment is ongoing and will exceed 35,000 in 2015. Uniquely, patients consent to (a) complete annual patient-reported outcomes (pain and function) and (b) report adverse events and surgical revisions at intervals for years into the future. A secure web-based data collection platform is used for direct data submission from patients and clinicians. Longitudinal data is complete with at least 85% follow-up for patient-reported outcomes.
The HealthEast Joint Replacement Registry (HJRR) began in 1991 and was the first community-based registry of its kind in the US. The HJRR has been influential in the development of the national system for orthopedic device study, and has been performing critical research studies and publishing their findings in the field for decades. The HJRR was one of the first participating sites during the development of the AJRR, and remains a charter member of the AJRR organization. They have been participating in ICOR since its inception in 2011.
Cafri G, Banerjee S, Sedrakyan A, Paxton L, Furnes O, Graves S, Marinac-Dabic D. Meta-analysis of survival curve data using distributed health data networks: application to hip arthroplasty studies of the International Consortium of Orthopaedic Registries. Res Synth Methods. 2015 Dec;6(4):347-56. doi: 10.1002/jrsm.1159. PubMed