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Prospective, Multi-Center Adolescent Clavicle Fracture Registry
Investigators from eight tertiary care, level 1 pediatric trauma centers have developed a protocol for the establishment of a formal, prospective multi-center adolescent clavicle registry, with designs for standardized radiographic assessment and the prospective collection of validated outcome measures and complications data, for all patients, ages 10-18, treated for clavicle shaft fractures, operatively and non-operatively. Eventually, the investigators would like to do comparative analysis for the operative and non-operative treatment arms, with additional sub-stratified analyses performed within these treatment arms by age and activity level. Among the primary goals of research projects stemming from the first arm of this registry, FACTS A, is to explore the hypothesis that non-operative treatment is associated with lower costs, greater safety, and equivalent or superior outcomes, compared with operative treatment, despite a national trend towards increasing surgical treatment. The second arm of the registry, FACTS B, will continue to investigate the same hypotheses, excluding cost outcomes, in patients only with completely displaced midshaft clavicle fractures.
Age
10 - 18 years
Sex
ALL
Healthy Volunteers
No
University of California San Francisco Benioff Children's Hospital Oakland
Oakland, California, United States
Rady Children's Hospital
San Diego, California, United States
Children's Healthcare of Atlanta
Atlanta, Georgia, United States
Boston Children's Hospital
Boston, Massachusetts, United States
University of Michigan Medical Center
Ann Arbor, Michigan, United States
Washington University at St. Louis
St Louis, Missouri, United States
Campbell Clinic Orthopaedics
Memphis, Tennessee, United States
Texas Scottish Rite Hospital
Dallas, Texas, United States
Start Date
March 11, 2013
Primary Completion Date
June 1, 2026
Completion Date
June 1, 2027
Last Updated
June 15, 2025
250
ESTIMATED participants
Surgery
PROCEDURE
Lead Sponsor
Boston Children's Hospital
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.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07414654