Appendix B. National and International Registries comprising the Ortho-CRN
Kaiser Permanente’s Total Joint Replacement Registry (TJRR)20 21The Kaiser permanente implant registries were developed in 2001 and modeled after the swedish Hip registry. kaiser permanente has several inter-regional implant registries that capture patient demographics, implant characteristics, surgical techniques, and outcomes, including a variety of orthopedic devices/surgeries such as total knee/hip, anterior cruciate ligament, 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 the clinical effectiveness of total joint replacement implants. The overarching goal of the registry is to enhancing quality and patient care. In addition to the inter-regional implant registries, Kaiser Permanente also has the world’s largest private-sector electronic health records, Kaiser Permanente HealthConnect®. Interconnection of all patient encounters within the electronic health records allows for the extraction of laboratory, procedural, diagnostic, pharmacy, and hospital encounters for all members in every patient care setting across Kaiser Permanente’s regions. These data supplement inter-regional implant registries and provide a foundation for longitudinal assessment of medical devices.
Michigan Arthroplasty Registry Collaborative Quality Initiative (MARCQI)24MARCQI started in 2012 as a major statewide quality improvement initiative to improve the care of hip and knee joint replacement surgery procedures. Since 2012, more than 70,000 hip replacements and over 130,000 knee replacements have been included and almost all hospitals and surgeons in Michigan participate in the registry. The registry captures 224 data elements, patient reported outcomes, procedure-related outcomes within 90-days, and revisions indefinitely. The registry is funded by Blue Cross and Blue Shield of Michigan and Blue Care Network, which enables a longitudinal assessment of revisions and other endpoints. MARCQI produces annual reports summarizing device-specific revision risks calculated from longitudinal assessments.
Function and Outcomes Research for Comparative Effectiveness in Total Joint Replacement (FORCE-TJR)22FORCE-TJR registry, created and managed by University of Massachusetts Medical School’s Department of Orthopedics, 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 exceeded 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.
International Consortium of Orthopedic Registries (ICOR)25ICOR captures over 5.2 million implants from 30 registries within 14 countries. This makes ICOR one of the largest collaborations between stakeholders with research and clinical expertise. These collaborations facilitate and enhance inter-registry collaboration to set up the infrastructure for a worldwide implant database. The developed infrastructure will promote international comparative effectiveness and device safety studies.