ICOR is a U.S. Food and Drug Administration-sponsored initiative that is quickly evolving into a public-private partnership, with over 30 registries participating worldwide. The purpose of ICOR is to facilitate and enhance inter-registry collaboration through the provision of a supportive infrastructure and the development of a distributed data network that uses innovative approaches to analyze the data.
Launched in 2011, the ICOR initiative addresses gaps in evidence and data related to medical implants. The network is composed of more than 70 stakeholders and over 30 orthopedic registries, representing 14 nations. Through a contract with the FDA, ICOR is implementing a worldwide surveillance system and meaningful unique device identification (UDI) system with two important goals: 1) demonstration projects of research and surveillance for hip and knee implants, and 2) harmonization of worldwide implant data through creation of an implant library.
Select a tab to learn more about two of the ICOR studies.
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.
Sedrakyan A, Graves S, Bordini B, Pons M, Havelin L, Mehle S, Paxton E, Barber T, & Cafri G. Comparative effectiveness of ceramic-on-ceramic implants in stemmed hip replacement: a multinational study of six national and regional registries. J Bone Join Surg Am. 2014;96(suppl 1):34-41.
Stea S, Comfort T, Sedrakyan A, Havelin L, Marinelli M, Barber T, Paxton E, Banerjee S, Isaacs AJ, & Graves S. Multinational comprehensive evaluation of the fixation method used in hip replacement: interaction with age in context. J Bone Join Surg Am. 2014;96(suppl 1):42-51.
Paxton E, Cafri G, Havelin L, Stea S, Palliso F, Graves S, Hoeffel D, & Sedrakyan A. Risk of revision following total hip arthroplasty: metal-on-conventional polyethylene compared with metal-on-highly cross-linked polyethylene bearing surfaces: international results from six registries. J Bone Join Surg Am. 2014;96(suppl 1):19-24.
Namba R, Graves S, Robertsson O, Furnes O, Stea S, Puig-Verdie L, Hoeffel D, Cafri G, Paxton E, & Sedrakyan A. International Comparative Evaluation of knee replacement with fixed or mobile non-posterior stabilized implants. J Bone Join Surg Am. 2014;96(suppl 1):52-58.
Comfort T, Baste V, Froufe MA, Namba R, Bordini B, Robertsson O, Cafri G, Paxton E, Sedrakyan A, & Graves S. International comparative evaluation of fixed-bearing non-posterior-stabilized total knee replacements. J Bone Join Surg Am. 2014;96(suppl 1):65-72.
Graves S, Sedrakyan A, Baste V, Gioe TJ, Namba R, Martinez Cruz O, Stea S, Paxton E, Banerjee S, Isaacs AJ, & Robertsson O. International comparative evaluation of knee replacement with fixed or mobile-bearing posterior-stabilized prostheses. J Bone Join Surg Am. 2014;96(suppl 1):59-64.
Allepuz A, Havelin L, Barber T, Sedrakyan A, Graves S, Bordini B, Hoeffel D, Cafri G, & Paxton E. Effect of femoral head size on metal-on-HXLPE hip arthroplasty outcome in a combined analysis of six national and regional registries. J Bone Join Surg Am. 2014;96(suppl 1):12-18.
Furnes O, Paxton E, Cafri G, Graves S, Bordini B, Comfort T, Rivas MC, Banerjee S, & Sedrakyan A. Distributed analysis of hip implants using six national and regional registries: comparing metal-on-matal with metal-on-highly cross-linked polyethylene bearings in cementless total hip arthroplasty in young patients. J Bone Join Surg Am. 2014;96(suppl 1):25-33.
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.