- November 4, 2021
The Food and Drug Administration (FDA) is announcing an annual meeting titled “Orthopedic Strategically Coordinated Registry Network (Ortho-CRN) Meeting.” This public meeting is intended to advance strategic and well-planned dialogue between the stakeholders regarding the Ortho-CRN. The annual meeting is to provide a forum to facilitate information exchange with stakeholders including members of the healthcare professionals, industry, patient groups, payers, academia, and government organizations.
Coordinated Registry Networks (CRNs) are a key MDEpiNet strategy to bring together real-world data from a variety of sources to address the needs of device evaluation for multiple stakeholders. The CRN approach addresses the limitations of traditional registries and data repositories by building linked data systems from multiple sources.
The meeting will provide a forum to facilitate information exchange among academic centers, health care professionals, and device manufacturers interested in developing products and ideas for a national patient-centered orthopedic medical device evaluation and surveillance system. The public meeting is not intended to communicate any new policies, processes or interpretations of FDA laws and regulations for medical devices.
This meeting will serve as a catalyst to foster communication and engagement by all stakeholders in the orthopedic community around this effort to promote medical device evaluation and surveillance. The topics for discussion include real world evidence, patient centered outcomes, and international and disparity research.
This meeting will be held November 4, 2021 from 9:00 a.m. to 4:00 p.m. ET by webcast only.
See biographies of the speakers [PDF - 4.6 MB]
|9:00 -9:15 am||Welcome and Opening Remarks||CAPT Raquel Peat, PhD, MPH, USPHS, FDA|
Master of Ceremony: Danica Marinac-Dabic, MD, PhD, MMSc, FISPE, FDA
|9:15-11:15 am||Session 1: Real-World Evidence Research||Moderators: CAPT Raquel Peat, PhD, MPH, USPHS, FDA and Janine Clayton, MD, NIH|
|9:15-9:25 am||Sex/Gender Diversity in Orthopedic Device Clinical Trials||Hongying Jiang, PhD, RAC, FDA|
|9:25-9:35 am||Sex/Gender Differences Studies in Hip Replacements||Amanda Chen, MS, Weill Cornell Medicine|
|9:35- 9:45 am||Sex/Gender Differences Studies in Knee Replacements||Suvekshya Aryal, MPH, Weill Cornell Medicine|
|9:45-9:55 am||Identifying Gene Frequencies That Are Associated with Early Joint Failure of Orthopedic Devices in Women||John Bowsher, PhD, FDA and Diane Smith, PhD, FDA|
|9:55-10:05 am||Real-World Epidemiologic and Genetic Evidence Reveals the Sex-Dependent Role of GNAS SNPs in Hip Arthroplasty Related Periprosthetic Osteolysis||Yelizaveta Torosyan, MD, PhD, FDA|
|10:05-10:20 am||Q&A Session: Sex/Gender Disparity||Group Discussion|
|10:30-10:40 am||Industry Perspective on Using Real-World Evidence for Regulatory Decision Making in Orthopedics||Paul Voorhorst, MS, MBA, DePuy Orthopedics|
|10:40-10:50 am||Evaluating Real-World Adverse Events and Risk Factors in Patients Undergoing Spinal Fusion with Interbody Fusion Devices||Brent L. Showalter, PhD, FDA|
|10:50-11:00 am||Kaiser Permanente Spine Registry- Evidence Based Medicine Driving Quality Improvement||Elizabeth Paxton, PhD, MA, Kaiser|
|11:00-11:15 am||Q&A Session: Coordination Among Academic Study Groups and Registries to Advance Knowledge Related to Pediatric and Adult Spinal Devices||Group Discussion|
|12:15-2:05 pm||Session 2: Patient Centered Outcomes||Moderators: Art Sedrakyan, MD, PhD, Weill Cornell Medicine and Vincent J. Devlin, MD, FDA|
|12:15-12:25 pm||Project in Orthopedics: Development of a Patient and Family Preference Survey and Shared Decision-Making Aid Related for Surgical Treatment of Pediatric Idiopathic Scoliosis||Michelle Marks, PT, MA, Setting Scoliosis Straight|
|12:25-12:35 pm||High-Performance Integrated Virtual Environment Data Platform Presentation||Vahan Simonyan, PhD, DNAHIVE|
|12:35-12:45 pm||Using Patient Reported Outcomes and Electronic Case Report Forms in Routine Practice to Advance Research and Surveillance: Case Study in Women’s Health||Bilal Chughtai, MD, Weill Cornell Medicine|
|12:45-12:55 pm||Potential Role for Mobile Applications for Collection of Patient Outcomes: Development of a Patient Application for Pediatric Scoliosis||A. Noelle Larson, MD, Mayo Clinic|
|12:55-1:10 pm||Next Steps with Pediatric Mobile Applications||Group Discussion|
|1:10-1:20 pm||Development of a Patient-Reported Outcome Measure for Use in Relation to Osseointegrated Prostheses||CAPT Jonathan Forsberg, MD, PhD, DOD|
|1:20-1:30 pm||ICD10 and Claims Data Use for Outcomes Research||Jialin Mao, MD, MSc, Weill Cornell Medicine|
|1:30-1:40 pm||Comparison Revision Rates in Total Ankle Replacements Versus Ankle Arthrodesis Using Claims Data||Hongying Jiang, PhD, FDA and Per-Henrik Randsborg, MD, PhD, Akershus University Hospital|
|1:40-1:50 pm||National Evaluation System for health Technology and Specific Use Case: Orthopedic Data Linkage Pilot||Flora Sandra Siami, MPH, NESTcc|
|1:50-2:05 pm||Q&A Session: Patient Centered Outcomes||Group Discussion|
|2:15 – 3:00 pm||Session 3: National and International Collaborations||Moderators:
Danica Marinac-Dabic, MD, PhD, MMSc, FISPE, FDA and Elizabeth Paxton, PhD, MA, Kaiser
|2:15 -2:25 pm||International Efforts: Prioritizing the Questions for USA-EU-AUS Collaborations||Robert Nelissen, MD, PhD, LUMC|
|2:25-2:35 pm||Distributed Analyses of National and International Data to Enable New Collaborations||Art Sedrakyan, MD, PhD, Weill Cornell Medicine and Elizabeth Paxton, PhD, MA, Kaiser|
|2:35-2:45 pm||Modernizing International Collaborations: Drivers, Tools and Models to Advance Partnerships||Danica Marinac-Dabic, MD, PhD, MMSc, FISPE, FDA|
|2:45- 3:00 pm||Q&A Session: Incentives for Collaborations||Group Discussion|
|3:00 -3:10 pm||Closing Remarks||Daniel Canos, PhD, MPH, FDA|
Registration is closed.
Please submit your comments regarding the meeting to https://www.regulations.gov, Docket No. FDA-2021-N-1062 by December 6, 2021.
Please refer to the Instructions for submitting comments to the docket to ensure that your feedback is received.
The resulting discussions from the meeting and comments received in the docket will be taken into consideration.
Please be advised that as soon as a transcript is available, it will be posted in the Dockets and accessible at http://www.regulations.gov.
For questions regarding the meeting content please contact:
Regulatory Health Project Manager
Office of Health Technology 6
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Food and Drug Administration
|Transcript Orthopedic Strategically Coordinated Registry Network Meeting 11-4-2021||pdf (806.55 KB)|