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
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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.
For further information on these project please contact us.
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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
FORCE-TJR Registry
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
OrthoCarolina
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
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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) ars2013@med.cornell.edu
ICOR Executive Committee
Chairman
Stephen Graves, MD, PhD segraves@aoanjrr.org.au
American Joint Replacement Registry
David Lewallen, MD lewallen.david@mayo.edu
European Arthroplasty Register
Gerold Labek, MD Gerold.Labek@i-med.ac.at
International Society of Arthroplasty Registries (ISAR) President
Göran Garellick, MD, PhD goran.garellick@registercentrum.se
ISAR Past President
Ove Furnes, MD ove.furnes@helse-bergen.no
International Advisor
Henrik Malchau, MD, PhD hmalchau@partners.org
National Joint Registry of England and Wales
Martyn Porter, FRCS martynporter@doctors.org.uk
or
Keith Tucker, FRCS ktucker77@aol.com
U.S. Registry Representative
Robert Namba, MD Robert.S.Namba@kp.org
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Art Sedrakyan ars2013@med.cornell.edu
Liz Paxton Liz.W.Paxton@kp.org
Courtney Baird ceb3003@med.cornell.edu
Rebecca Love Rebecca.M.Love@kp.org