The ICOR (http://www.icor-initiative.org/) is a worldwide initiative that has enabled collaboration of orthopedics registries. There are more than 10 million patients enrolled in these registries worldwide that capture all implantable devices on the market. Various stakeholder come together to build this consortium to collaborate and focus on understanding the variability in outcomes of total hip arthroplasty (THA) and total knee arthroplasty (TKA) devices. National and international orthopedics registries that are at various stages of development participate in building this comprehensive network that helps utilize the international data sources and methods for post-market evaluations and surveillance of orthopedic devices. This initiative has built methodological infrastructure to evaluate orthopedic implant safety and effectiveness and assist participating organizations with the creation of a learning network.
ICOR 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. The conference attendees included 73 stakeholders from 29 orthopedic joint registries (total joint arthroplasty) representing 14 nations as well as non-registry stakeholders representing industry. Attendees also included Agency for Healthcare Research and Quality (AHRQ), National Institute of Health (NIH), CMS, academia, device regulatory agencies, device cataloguing experts, insurers and payers. Since then, ICOR has expanded internationally to facilitate and enhance inter-registry collaboration through supportive infrastructure and the development of a distributed data network that uses innovative approaches to analyze the data.
The major objectives of ICOR have been developing priorities that reflect the consensus of different stakeholders, addressing the impact of rapid innovations in devices, filling in the gaps in device identification (in the absence of unique identifiers), using a systematic approach to medical device research, addressing large evidence gaps on new and evolving devices as well as the high cost of trials in both the pre-market and post-market area, as well as understanding individual device performance. The ICOR aimed to leverage resources and expertise from multiple stakeholders toward the development and application of innovative methods to address methodological gaps in studying orthopedic devices.
ICOR has been hugely successful and has achieved all its objectives. As a pioneering effort in a space of international collaborations, ICOR enabled more than 30 primary investigations that addressed the most urgent issues in orthopedics such as performance of metal on metal implants, various bearings, and new technologies. ICOR developed an innovative distributed data network model to study the performance of devices and advanced the methodological approaches to analysis of registry data. Examples include:
1. International comparative evaluation of knee replacement with fixed vs mobile non-posterior stabilized implants.
2. International comparative evaluation of knee replacement with fixed vs mobile posterior stabilized implants.
3. International comparative evaluation of fixed cruciate retaining versus fixed posterior cruciate substituting total knee replacement.
4. Evaluation of head size on outcomes of hip replacement in a combined analysis of six international registries focusing on metal on highly cross-linked polyethylene bearings.
5. Comparative Effectiveness of Ceramic on Ceramic Implants in Stemmed Hip Replacement: Multinational Study of Six International Registries.
6. Distributed analysis of hip implants using six national and regional registries comparing metal on metal to metal on highly cross-linked polyethylene bearings in uncemented THA in young patients.
7. THA risk of revision: Metal on conventional versus metal on crosslinked results from six international registries.
8. Multinational Comprehensive Evaluation of Fixation Method Used in Hip Replacement: Interaction with Age in Context.
Another important objective and achievement of ICOR was the development of internationally harmonized Implant Library for Orthopedic Implants. The creation of an orthopedic implant library and relevant nomenclature for device attributes and characteristics is the critical link with clinical and research community interested in devices from post-market surveillance and research perspectives when using registries. In orthopedics, large registries or networks of registries capture device information on a very detailed level and can become particularly important for active surveillance and post-market evaluation. The registries can also provide denominator data for specific devices implants and facilitate comparative studies. This is especially the case in settings where participation with the registry is mandatory or the registries have over 90% coverage of the exposed population.
The FDA UDI rule mandates that manufacturers must label medical devices with an UDI identifier to populate the GUDID, a public hub of standardized UDI data intended to integrate with billing, inventory, and electronic surveillance. The ICOR implant library of clinical attributes and characteristics is as an adjunct database to GUDID. The ICOR library facilitated standardized processes that enabled the development of a universal implant library that all registries could use for consistency of reporting and enhanced inter-registry collaboration.
The ICOR brought together global partners and helped launch the US chapter (ICOR-USA) that is now developing a US national device surveillance network in the orthopedic device space.
Many international registries have established MOUs with the MDEpiNet Coordinating Center and are members of MDEpiNet International Committee.
ICOR CRN’s patient population came from participating countries and registries listed below in Table 1.
The ICOR uses registry data from and collaborates closely with the International Society of Arthroplasty Registries (ISAR).
Current Projects and Plans
The current focus of the ICOR CRN is to facilitate the ICOR-USA (Ortho-CRN) project development focusing on OPC for hip and knee replacement devices. The project will have global implications and will also lead to future projects such as objective performance goals (OPG) development for shoulder and spine devices.
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
Mission and Current Projects
The mission of the International Consortium of Orthopedic Registries (ICOR) Initiative is to facilitate international registry stakeholders’ collaboration and develop innovative methodological approaches for conducting robust analytic studies to fill the evidence gaps. The additional goal is to improve FDA’s understanding of safety and effectiveness of orthopedic devices.
In order to accomplish this mission, we have begun work on three projects:
1. Development of worldwide implant (prosthesis) database
The purpose of this project is to develop a universal prosthesis database and classification system to standardize prosthesis classification and enhance total joint arthroplasty research collaboration worldwide. The implants of interest are all hip and knee arthroplasty prostheses.
2. Comparison of various bearings used in stemmed hip replacement
The purpose of this project is to understand whether different bearing surfaces in hip arthroplasty surgery have different failure modes and revision rates. This project will target primary total hip arthroplasties and will consider any revision, defined as removal, exchange or addition of any implant part (including exchange of inserts and heads only) as the primary outcome variable.
3. Comparison of various fixed and mobile bearings used in knee replacement
The purpose of this project is to measure whether mobile bearing designs will have a higher rate of aseptic revision than fixed total knee arthroplasties after adjusting for appropriate factors, such as age, gender, and co-morbidities. This project will target primary total knee arthroplasties.
We have reached out and formalized, or are in the process of formalizing, a cooperative agreement with the following organizations:
American Joint Replacement Registry
Australian Orthopaedic Association National Joint Replacement Registry
California Joint Replacement Registry
Canadian Joint Replacement Registry
Catalan Arthroplasty Register
Croatian Arthroplasty Register
Czech Republic National Register of Joint Replacements
Danish Hip Arthroplasty Register
Danish Knee Arthroplasty Register
Dutch Arthroplasty Register (NOV-LROI)
Finnish National Arthroplasty Register
German Arthroplasty Register
Harris Joint Registry at Massachusetts General Hospital
HealthEast Joint Replacement Registry
Hospital for Special Surgery
Kaiser Permanente National Implant Registries
Lithuanian Arthroplasty Register
Malawi National Arthroplasty Registry
Mayo Clinic Total Joint Registry
National Joint Registry for England and Wales
New England Baptist Hospital Registry
New Zealand National Joint Register
Norwegian Arthroplasty Register
Portuguese National Arthroplasty Register
Registro Ortopedico Lombardo Protesi (ROLP)
RIPO – Register of Orthopaedic Prosthetic Implants
Romanian Arthroplasty Register
Rush University Medical Center Joint Replacement Registry
Scottish Arthroplasty Project
Slovakian National Arthroplasty Register
Slovenian Arthroplasty Register
SoFCOT THA Registry
South African National Joint Registry
Swedish Hip Arthroplasty Register
Swedish Knee Arthroplasty Register
U.S. FDA Coordinating Center
U.S. FDA Coordinating Center and Kaiser Permanente Total Joint Replacement Registry
University of California, San Francisco
Virginia State Registry
Western Slope Study Group
United States (U.S.) Food and Drug Administration (FDA) Advisor
Danica Marinac-Dabic, MD, PhD
U.S. FDA Coordinating Center
Liz Paxton, MA Liz.W.Paxton@kp.org
Art Sedrakyan, MD, PhD (Principal Investigator of the contract) email@example.com
ICOR Executive Committee
Stephen Graves, MD, PhD firstname.lastname@example.org
American Joint Replacement Registry
European Arthroplasty Registery
International Society of Arthroplasty Registries (ISAR) President
ISAR Past President
Ove Furnes, MD email@example.com
Henrik Malchau, MD, PhD firstname.lastname@example.org
National Joint Registry of England and Wales
Martyn Porter, FRCS email@example.com
Keith Tucker, FRCS firstname.lastname@example.org
U.S. Registry Representative
Robert Namba, MD Robert.S.Namba@kp.org
ICOR has established a distributed data system where standardized data extraction is implemented by the ICOR coordinating center and distributed to participating registries (see Figure 1). Each registry completes the analyses and then de-identified, detailed data summaries including all subgroup effects and interactions are shared with the coordinating center. The data are combined in order to investigate the frequency of revision after surgery, which reflects the patients experience and indicates failure of the implant as well the pain and suffering that necessitates a second surgery.
Over 30 projects have been completed and published.
The creation of an implant library and relevant nomenclature for device attributes and characteristics is a critical step in linking the clinical and research communities and facilitating the post-market surveillance of medical devices. In orthopedics, large registries or networks of registries can capture device information on a very detailed level and are particularly important for active surveillance and post-market evaluation. The registries can provide denominator data for adverse events related to specific implants and allow proper conduct of comparative effectiveness studies.
The FDA Unique Device Identifier (UDI) rule mandates that manufacturers must label medical devices with a UDI code that identifies model and production characteristics. Additionally, manufacturers must provide the FDA with the attributes of UDI-labeled devices to populate the Global Unique Device Identification Database (GUDID), a public hub of standardized UDI data intended to integrate with billing, inventory, and electronic records. The ICOR implant library of clinical attributes and characteristics is an adjunct database to GUDID (see Figure 2).
In order to monitor and evaluate total joint arthroplasty procedures, the specific devices used must be accurately identified and classified. The ICOR Initiative facilitated a standardized process that enabled the development of a universal implant library that all registries could use for consistency of reporting and enhanced inter-registry collaboration. The ICOR process is based on a catalogue number assigned by a company to an implant that will be specific for a particular size or configuration. Any change to the design of an implant necessitates a change in the catalogue number. The combination of manufacturer name and catalogue number leads to unique identification of 99% of products. ICOR is continuing to work with registries to reduce the burden of maintenance and updates for their individual databases based on catalog numbers. As UDI becomes available the registries will also link implant characteristics to UDI.
ICOR is a collaborative effort that brings together leaders in implant device regulatory research from around the world. Below you will find articles, presentations and op-ed pieces published as a result of this collaboration.
|full text >>||Patricia D. Franklin, MD, MBA, MPH; David Lewallen, MD; Kevin Bozic, MD, MBA; Brian Hallstrom, MD; William Jiranek, MD; David C. Ayers, MD||Implementation of Patient-Reported Outcome Measures in U.S. Total Joint Replacement Registries: Rationale, Status, and Plans|
|full text >>||Lucas Romero, MPA; Marc Nieuwenhuijse, MD, PhD; Andrew Carr, FMedSci; Art Sedrakyan, MD, PhD||Review of Clinical Outcomes-Based Anchors of Minimum Clinically Important Differences in Hip and Knee Registry-Based Reports and Publications|
|full text >>||J. Christiaan Keurentjes, MD; Bart G. Pijls, MD, PhD; Floris R. Van Tol, MSc; Jill F. Mentink, MD; Stephanie D. Mes, MD; Jan W. Schoones, MSc; Marta Fiocco, PhD; Art Sedrakyan, MD, PhD; Rob G. Nelissen, MD, PhD||Which Implant Should We Use for Primary Total Hip Replacement? A Systematic Review and Meta-Analysis|
|full text >>||Art Sedrakyan, MD, PhD; Lucas Romero, MPA; Stephen Graves, MBBS, DPhil, FRACS, FAOrthA; David Davidson, MBBS, FRCSEd, FRACS; Richard de Steiger, MBBS; Peter Lewis, MBBS, FRACS(Orth), FAOrthA; Michael Solomon, MBChB, FRACS(Orth); Robyn Vial, MAppSc(Pharm); Michelle Lorimer, BSc(Maths&CompSc)(Hons)||Survivorship of Hip and Knee Implants in Pediatric and Young Adult Populations: Analysis of Registry and Published Data|
|full text >>||Thomas Comfort, MD; Valborg Baste, PhD; Miquel Angel Froufe, Dr; Robert Namba, MD; Barbara Bordini, BSc; Otto Robertsson, Med Dr; Guy Cafri, PhD, MStat; Elizabeth Paxton, MA; Art Sedrakyan, MD, PhD; Stephen Graves, MBBS, DPhil, FRACS, FAOrthA||International Comparative Evaluation of Fixed-Bearing Non-Posterior-Stabilized and Posterior-Stabilized Total Knee Replacements|
|full text >>||Stephen Graves, MBBS, DPhil, FRACS, FAOrthA; Art Sedrakyan, MD, PhD; Valborg Baste, PhD; Terence J. Gioe, MD; Robert Namba, MD; Olga Martínez Cruz ; Susanna Stea, BSc; Elizabeth Paxton, MA; Samprit Banerjee, PhD; Abby J. Isaacs, MS; Otto Robertsson, Med Dr||International Comparative Evaluation of Knee Replacement with Fixed or Mobile-Bearing Posterior-Stabilized Prostheses|
|full text >>||Robert Namba, MD; Stephen Graves, MBBS, DPhil, FRACS, FAOrthA; Otto Robertsson, Med Dr; Ove Furnes, MD, PhD; Susanna Stea, BSc; Lluis Puig-Verdié, PhD; Daniel Hoeffel, MD; Guy Cafri, PhD, MStat; Elizabeth Paxton, MA; Art Sedrakyan, MD, PhD||International Comparative Evaluation of Knee Replacement with Fixed or Mobile Non-Posterior-Stabilized Implants|
|full text >>||Susanna Stea, BSc; Thomas Comfort, MD; Art Sedrakyan, MD, PhD; Leif Havelin, MD, PhD; Marcella Marinelli, PhD, MSc; Thomas Barber, MD; Elizabeth Paxton, MA; Samprit Banerjee, PhD; Abby J. Isaacs, MS; Stephen Graves, MBBS, DPhil, FRACS, FAOrthA||Multinational Comprehensive Evaluation of the Fixation Method Used in Hip Replacement: Interaction with Age in Context|
|full text >>||Art Sedrakyan, MD, PhD; Stephen Graves, MBBS, DPhil, FRACS, FAOrthA; Barbara Bordini, BSc; Miquel Pons, MD; Leif Havelin, MD, PhD; Susan Mehle ; Elizabeth Paxton, MA; Thomas Barber, MD; Guy Cafri, PhD, MStat||Comparative Effectiveness of Ceramic-on-Ceramic Implants in Stemmed Hip Replacement: A Multinational Study of Six National and Regional Registries|
|full text >>||Ove Furnes, MD, PhD; Elizabeth Paxton, MA; Guy Cafri, PhD, MStat; Stephen Graves, MBBS, DPhil, FRACS, FAOrthA; Barbara Bordini, BSc; Thomas Comfort, MD; Moises Coll Rivas, MD; Samprit Banerjee, PhD; Art Sedrakyan, MD, PhD||Distributed Analysis of Hip Implants Using Six National and Regional Registries: Comparing Metal-on-Metal with Metal-on-Highly Cross-Linked Polyethylene Bearings in Cementless Total Hip Arthroplasty in Young Patients|
|full text >>||Elizabeth Paxton, MA; Guy Cafri, PhD, MStat; Leif Havelin, MD, PhD; Susanna Stea, BSc; Francesc Pallisó, MD; Stephen Graves, MBBS, DPhil, FRACS, FAOrthA; Daniel Hoeffel, MD; Art Sedrakyan, MD, PhD||Risk of Revision Following Total Hip Arthroplasty: Metal-on-Conventional Polyethylene Compared with Metal-on-Highly Cross-Linked Polyethylene Bearing SurfacesInternational Results from Six Registries|
|full text >>||Alex Allepuz, MD, MPH; Leif Havelin, MD, MPH; Thomas Barber, MD; Art Sedrakyan, MD, PhD; Stephen Graves, MBBS, DPhil, FRACS, FAOrthA; Barbara Bordini, BSc; Daniel Hoeffel, MD; Guy Cafri, PhD, MStat; Elizabeth Paxton, MA||Effect of Femoral Head Size on Metal-on-HXLPE Hip Arthroplasty Outcome in a Combined Analysis of Six National and Regional Registries|
|full text >>||Samprit Banerjee, PhD; Guy Cafri, PhD, MStat; Abby J. Isaacs, MS; Stephen Graves, MBBS, DPhil, FRACS, FAOrthA; Elizabeth Paxton, MA; Danica Marinac-Dabic, MD, PhD; Art Sedrakyan, MD, PhD||A Distributed Health Data Network Analysis of Survival Outcomes: The International Consortium of Orthopaedic Registries Perspective|
|full text >>||Art Sedrakyan, MD, PhD; Elizabeth Paxton, MA; Stephen Graves, MBBS, DPhil, FRACS, FAOrthA; Rebecca Love, MPH, RN; Danica Marinac-Dabic, MD, PhD||National and International Postmarket Research and Surveillance Implementation: Achievements of the International Consortium of Orthopaedic Registries Initiative|
|full text >>||Elizabeth W. Paxton, MA, Ove Furnes, MD, PhD, Robert S. Namba, MD, Maria C.S. Inacio, MS, Anne M. Fenstad, MSc, and Leif I. Havelin, MD, PhD||Comparison of the Norwegian Knee Arthroplasty Register and a United States Arthroplasty Registry|
|full text >>||Stephen Graves, Alastair Rothwell, Keith Tucker, Joshua Jacobs, Art Sedrakyan||A Multinational Assessment of Metal-on-Metal Bearings in Hip Replacement|
|full text >>||Art Sedrakyan, MD, PhD, Elizabeth W. Paxton, PhD, Charlotte Phillips, PhD, Robert Namba, MD, Tadashi Funahashi, MD, Thomas Barber, MD, Thomas Sculco, MD, Douglas Padgett, MD, Timothy Wright, PhD, and Danica Marinac-Dabic, MD, PhD||The International Consortium of Orthopaedic Registries|
|full text >>||Rajan Anand, MBBS, Stephen E. Graves, MBBS, DPhil, FAOrthA, Richard N. de Steiger, MBBS, Dip Biomech, FRACS(Orth), David C. Davidson, MBBS, FRCSEd, FAOrthA, Philip Ryan, MBBS, BSc, FAFPHM, Lisa N. Miller, BSc Hons (Math), and Kara Cashman, BSC Hons (O&G), Grad Dip Math Sc||What Is the Benefit of Introducing New Hip and Knee Prostheses?|
|full text >>||Leif I. Havelin, MD, PhD, Otto Robertsson, MD, PhD, Anne M. Fenstad, MSc, Søren Overgaard, MD, PhD, G¨oran Garellick, MD, PhD, and Ove Furnes, MD, PhD||A Scandinavian Experience of Register Collaboration: The Nordic Arthroplasty Register Association (NARA)|
|full text >>||Gerold Labek, MD, Daniel Neumann, MD, Mark Agreiter, MD, Reinhard Schuh, MD, and Nikolaus B¨ohler, MD||Impact of Implant Developers on Published Outcome and Reproducibility of Cohort-Based Clinical Studies in Arthroplasty|
|full text >>||Gavin J. Macpherson, MBChB, MRCS Ed, Ivan J. Brenkel, BSC, MBChB, FRCS Ed, Rik Smith, PhD, and Colin R. Howie, MBChB, FRCS Ed||Outlier Analysis in Orthopaedics: Use of CUSUM. The Scottish Arthroplasty Project: Shouldering the Burden of Improvement|
|full text >>||Gregory B. Maletis, MD, Lars-Petter Granan, MD, PhD, Maria C.S. Inacio, MS, Tadashi T. Funahashi, MD, and Lars Engebretsen, MD, PhD||Comparison of Community-Based ACL Reconstruction Registries in the U.S. and Norway|
|full text >>||Robert S. Namba, MD, Maria C.S. Inacio, MS, Elizabeth W. Paxton, MA, Otto Robertsson, MD, PhD, and Stephen E. Graves, MD, DPhil||The Role of Registry Data in the Evaluation of Mobile-Bearing Total Knee Arthroplasty|
|full text >>||Rob G.H.H. Nelissen,MD, PhD, Bart G. Pijls, MD, Johan K¨arrholm, MD, PhD, Henrik Malchau, MD, PhD, Marc J. Nieuwenhuijse, MD, and Edward R. Valstar, MSc, PhD||RSA and Registries: The Quest for Phased Introduction of New Implant|
|full text >>||Otto Robertsson, MD, PhD, Stan Mendenhall, MA, MS, Elizabeth W. Paxton, MA, Maria C.S. Inacio, MS, and Stephen Graves, MB, BS, PhD||Challenges in Prosthesis Classification|
|full text >>||Ola Rolfson, MD, PhD, Alastair Rothwell, ChM, FRACS, Art Sedrakyan, MD, PhD, Kate Eresian Chenok, MBA, Eric Bohm, BEng, MD, MSc, FRCSC, Kevin J. Bozic, MD, MBA, and G¨oran Garellick, MD, PhD||Use of Patient-Reported Outcomes in the Context of Different Levels of Data|
|full text >>||Keith Tucker, FRCS, Paul Gregg, MD, FRCS, Peter Kay, FRCS, Martyn Porter, FRCS, Peter Howard, FRCS, Martin Pickford, PhD, and Crina Cacou, PhD||Monitoring the Introduction and Performance of a Joint Replacement: The United Kingdom Metal-on-Metal Alert|
|full text >>||Art Sedrakyan, MD, PhD, Elizabeth W. Paxton, MA, and Danica Marinac-Dabic, MD, PhD||Stages and Tools for Multinational Collaboration: The Perspective from the Coordinating Center of the International Consortium of Orthopaedic Registries (ICOR)|
ICOR-USA (Ortho CRN)
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.
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 November 2016, AJRR enrolled 826 hospitals from all 50 states and the District of Columbia nearly 600,000 procedures have been submitted to AJRR, with the most recent year of data submissions 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 the HealthEast Joint Replacement Registry and the Connecticut Joint Replacement Institute.. It includes as participants 20 of the top 25 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 is created and managed by University of Massachusetts Medical School’s Department of Orthopaedics. To date, FORCE-TJR has collected and analyzed comprehensive post-TJR data on more than 30,000 patients treated by a diverse and nationally representative group of surgeons, and hospitals in 24 states. Urban and rural environments, academic and community hospitals, and low and high volume practices are represented. 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. Data from patients and clinicians is supplemented with data from a variety of other sources including administrative claims, implant data, and x-rays.
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