Multi-Center Adolescent Clavicle Fracture Trial: Operative vs. Non-Operative Treatment

Running, not enrolling

Conditions studied: Clavicle Fracture

In brief

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.

Key facts

Study ID

NCT04250415

Run by

Boston Children's Hospital

People needed

250

Starts

2013-03-11

Expected to finish

2027-06-01

Last updated by the study team

2025-06-15

Who can join

Age: 10 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Aged 10-18
• Diagnosis of a primary diaphyseal clavicle fracture
• Fracture must be completely displaced
• Patient - BCH subjects must pursue follow-up at BCH main campus or Waltham must be 59 days or less from the primary fracture
• All study patients (across all sites) must agree to be contacted by a long-term follow-up coordinator based out of Boston Children's Hospital for long-term follow-up questions (out to the 2-year time point). This can/will be done via phone, mail, text message, and/or email.

You may not qualify if…

• Pathological fracture
• Previous ipsilateral fracture
• Unable to fill out outcome collection forms
• Refusal to participate
• Underlying neurologic or neurocognitive disorder that affects UE function
• Underlying metabolic bone disorder (e.g. osteogenesis imperfecta) that significantly alters normal bone healing
• Unable to project injury X-ray films if treated initially at an institution that is not a member of this register

Where it is running

• 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

Full record on ClinicalTrials.gov

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