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DegenPRO: A Multicenter Prospective Registry for the Management of Degenerative Spine Disorders
Details regarding the degenerative spine disorders will be collected with a specific focus on the use of osteobiologics in treating degenerative conditions and their impact on fusion, as well as patient-reported outcomes for these conditions.
The registry is designed to be open-ended. However, a statistical evaluation of the content und structure of database and CRFs in order to investigate the feasibility and quality of data collection is planned to take place prior to the registry expansion. Variables applicable to patients with a degenerative spine disorder which will be collected in the registry include: * Patient details * Symptoms * Diagnosis * Imaging assessment * Treatment details Feasibility phase: The statistical evaluation of the feasibility and quality of data collection will be performed after the first 5 sites have each enrolled 12 patients with a degenerative pathology and documented one follow-up visit. During this evaluation, enrolment of further patients can be continued. Based on the findings of this feasibility phase, adjustments to the existing database can be performed before the registry is rolled out on larger scale. Registry expansion: Following the evaluation process of the feasibility phase, the registry will be expanded to allow data entry in more sites globally. Multi-site participation of this registry will be rolled-out in stages, and will be offered to sites with appropriate expertise which are selected based on their potential (interest, resources and expected patient volume).
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
USC Spine Center, Keck Medical Center of USC
Los Angeles, California, United States
Emory University School of Medicine
Atlanta, Georgia, United States
The Johns Hopkins University
Baltimore, Maryland, United States
Mount Sinai Hospital
New York, New York, United States
New York Presbyterian - Columbia University Medical Center
New York, New York, United States
BG-Clinic Bergmannstrost
Halle, Germany
Istituto Ortopedico Rizzoli
Bologna, Italy
Start Date
January 1, 2016
Primary Completion Date
December 1, 2026
Completion Date
December 1, 2026
Last Updated
March 20, 2024
908
ACTUAL participants
Lead Sponsor
AO Innovation Translation Center
Collaborators
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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