History

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.

 For further information on these project please contact us.

Member Organizations

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

Structure

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

Contact

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