ICOR-USA Collaboration

Background

Total joint replacement is the fastest growing elective device-based surgery with over 1.2 million hip and knee replacements performed annually in the US19. 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, volumes of procedure 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 US today. There is an increased need of network to maintain resources and address the safety and effectiveness of new devices that enter routine usage, as major evidence gaps in device performance exist as well as a need for novel partnership that can build a national infrastructure to fill the gaps in evidence.

Building from the major successes of the International Consortium of Orthopedic Registries (ICOR), the Orthopedics (Ortho) CRN aims to bring together national registries in the US in a systematic way and obtain longer, more complete patient follow-up via data linkages. Ortho CRN utilizes multiple data networks, allowing researchers to conduct comparative effectiveness studies within a short period after the devices’ 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 allows the network of registries to contribute to hospitals by providing more detailed, useful reports.

Objectives

The objective of the Ortho CRN is to share knowledge about best practices for data collection, linkages with claims and other data systems, analytics, and dissemination, which in turn allows registries to better serve as a high-quality data source utilized for research and the generation of useful reports. The major goals are to develop a framework for a US total joint replacement registries’ collaboration to conduct signal detection and confirmatory studies using existing US registry data; to collaborate with international registries to investigate device signals and conduct comparative effectiveness research; to provide a platform for collaborative post-market surveillance of implants in the US.; and to facilitate tracking of implants for optimal regulatory process.

Partnership Structure

The Ortho CRN is made possible by the collaboration and partnership between the MDEpiNet Coordinating Center, the FDA, and representatives of orthopedic registries such as the American Joint Replacement Registry (AJRR), Kaiser Permanente’s (KP) Total Joint Replacement Registry (TJRR), the Function and Outcomes Research for Comparative Effectiveness in Total Joint Replacement (FORCE-TJR) registry and hospital for Special Surgery (HSS) registry, and The Michigan Arthroplasty Registry Collaborative Quality Initiative (MARCQI).
The CRN has a Steering Committee/Working Group that consists of representatives from the FDA, regsitries and relevant organizations.

Ortho CRN is led and supported by the team of collaborators that include Liz Paxton (KP), Raquel Peat (FDA), Art Sedrakyan (Weill Cornell Medicine) and Danica Marniac-Dabic (FDA).

International effort: Globally, the International Consortium of Orthopedic Registries (ICOR) worked to bring together global partners to facilitate this registry. More information about ICOR can be found in the next section.

Existing agreements
The Ortho CRN leads have established MOUs with the MDEpiNet Coordinating Center to join the CRN COP and are members of the MDEpiNet EOC.

Data Infrastructure

Patient population
Currently the CRN is focusing on all patients undergoing hip and knee surgery. Starting in 2010 the CRN also focused on patients undergoing shoulder and spine surgery in the US.

Data sources
Kaiser Permanente (KP) 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 (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.

AJRR captures hip and knee arthroplasty procedures from multiple sites across the US. Patients are followed up between 270 and 365 days after the procedure. AJRR reports that 1,735,066 hip and knee replacement procedures that enrolled from 1,312 participating sites with 9,172 surgeons with all 50 US States represented. The registry conducts linkages with Medicare to obtain revision rates and other relevant outcomes.

MARCQI 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 in the registry and almost all hospitals and surgeons in Michigan participate in the registry. The registry is funded by Blue Cross and Blue Shield of Michigan and Blue Care Network, which enables longitudinal assessment of revisions and other endpoints.

FORCE-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.

Current Projects and Plans

ORTHO CRN’s are currently invested in several research and projects including the objective performance criteria development (OPC) project, spine and shoulder project, and several linkage projects that are described below:

OPC development project: The OPC development for hip and knee replacements project is led by the Ortho CRN team from MDEpiNet, FDA, and KP to expand the capacity of the CRN to produce reliable and relevant evidence, and align with international partnerships. The aim is to develop OPC measures for major outcomes following primary hip and knee replacements, utilizing RWE, including registries and claims data within the Ortho CRN network and literature review. The project primarily focuses on 2-year endpoints of all-cause and cause-specific revisions as well as disease specific and general health PROs. Benchmarking methods and literature review are planned to be used to develop OPCs. The project aims to explore the feasibility to use real-world data sources to scientifically develop OPC that could be utilized in pre-market IDE clinical studies. This project will help FDA, device innovators and manufacturers to adopt least burdensome approach for evidence generation and reduce the costs of clinical trials. For many 510K devices, OPCs will encourage evidence-based competition among manufacturers.

Spine and shoulder projects: The CRN focuses on the evaluation of several orthopedic conditions and treatments including pediatric spinal disorders, adult spinal disorders, shoulder and elbow surgery, osseointegrated prosthesis for amputees, and foot and ankle surgery. Currently 1-year data for shoulder surgery has been assessed, the elbow surgery evaluation has begun, and preliminary results have been generated in the evaluation of rotator cuffs.

Data linkage projects: Ortho CRN has completed linkages between registries and state/national claims datasets to significantly advance registry efforts, including validation of complications, increased follow-up rate, ability for risk adjustment, and increased information about patient characteristics. Currently four registries are partners in this national effort and havecreated core minimum data for harmonization of analytic process and conducted linking clinical registry information from diverse registries in the orthopedic setting. AJRR is currently leading the linkages of CMS data and third-party payer claims.

The completed claims data linkage demonstration projects highlight the importance of linking registries and other existing administrative data to provide necessary infrastructure in the US for medical device evaluation. This work serves as the foundation for future clinical studies to general US evidence and provides a mechanism for surveillance within the US. The Ortho CRN also leverages the supplementary device attribute database developed by its international chapter ICOR.

Collaborators

Kaiser Permanente

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.

American Joint Replacement Registry

 

Weill Cornell Medicine

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.

Medical Device Epidemiology Network (MDEpiNet)

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.

FORCE-TJR

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.

HealthEast

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.

Publications

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

Art Sedrakyan, MD, PhD

 

 

 

 

Liz Paxton, MA

 

 

 

 

Patricia Franklin, MD

 

 

 

 

 

Raquel Peat, PhD, MPH

 

 

 

 

Stephen C. Weber, M.D.

 

 

 

 

 

 

Vincent J. Devlin, M.D.

 

 

 

 

 

Brian R. Hallstrom, MD, FAOA