Comparing surgical and non-surgical treatments for adolescent clavicle fractures

Prospective, Multi-Center Adolescent Clavicle Fracture Registry

This study is trying to see if treating broken collarbones in teens without surgery is safer and cheaper while still helping them heal as well as surgery does.

Quick facts

• Study type: Observational
• Enrollment: 250 (estimated)
• Ages: 10 Years to 18 Years
• Sex: All
• Sponsor: Boston Children's Hospital (Academic / other)
• Locations: 8 sites (Oakland, California and 7 other locations)
• Trial ID: NCT04250415 on ClinicalTrials.gov

What this trial studies

This study aims to establish a multi-center registry for adolescents aged 10-18 with clavicle shaft fractures, collecting data on both operative and non-operative treatment approaches. Conducted across eight leading pediatric trauma centers, the registry will standardize radiographic assessments and gather validated outcome measures and complications. The primary goal is to analyze whether non-operative treatment offers lower costs and greater safety while achieving comparable or better outcomes than surgical treatment. The study will also explore variations in outcomes based on age and activity level.

Who should consider this trial

Good fit: Ideal candidates for this study are adolescents aged 10-18 with a completely displaced primary diaphyseal clavicle fracture.

Not a fit: Patients with pathological fractures, previous ipsilateral fractures, or underlying conditions affecting bone healing may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide insights that lead to more effective and cost-efficient treatment options for adolescent clavicle fractures.

How similar studies have performed: Previous studies have shown varying success in comparing surgical and non-surgical treatments for fractures, but this registry approach is relatively novel.

Eligibility criteria

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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 this trial is running

Oakland, California and 7 other locations

• University of California San Francisco Benioff Children's Hospital Oakland — Oakland, California, United States (Recruiting)
• Rady Children's Hospital — San Diego, California, United States (Recruiting)
• Children's Healthcare of Atlanta — Atlanta, Georgia, United States (Recruiting)
• Boston Children's Hospital — Boston, Massachusetts, United States (Recruiting)
• University of Michigan Medical Center — Ann Arbor, Michigan, United States (Recruiting)
• Washington University at St. Louis — Saint Louis, Missouri, United States (Recruiting)
• Campbell Clinic Orthopaedics — Memphis, Tennessee, United States (Recruiting)
• Texas Scottish Rite Hospital — Dallas, Texas, United States (Recruiting)

Study contacts

• Principal investigator: Benton E Heyworth, MD — Boston Children's Hospital
• Study coordinator: Lauren Hutchinson, MPH

Conditions Clavicle Fracture; Adolescent