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.
Clavicle Fracture
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.
Multi-Center Adolescent Clavicle Fracture Trial: Operative Vs. Non-Operative Treatment
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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, 02115
University of Michigan Medical Center, Ann Arbor, Michigan, United States,
Washington University at St. Louis, Saint Louis, Missouri, United States,
Campbell Clinic Orthopaedics, Memphis, Tennessee, United States,
Texas Scottish Rite Hospital, Dallas, Texas, United States,
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
For general information about clinical research, read Learn About Studies.
10 Years to 18 Years
ALL
No
Boston Children's Hospital,
Benton E Heyworth, MD, PRINCIPAL_INVESTIGATOR, Boston Children's Hospital
2026-06-01