Multi-Center Adolescent Clavicle Fracture Trial: Operative vs. Non-Operative Treatment (NCT04250415)
Prospective, Multi-Center Adolescent Clavicle Fracture Registry
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: University of California San Francisco Benioff Children's Hospital Oakland — Oakland, California
Age range: 10 Years to 18 Years
🧪 Interventions in This Study
- Surgery (PROCEDURE)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (8 Sites)
- University of California San Francisco Benioff Children's Hospital Oakland — Oakland, California
- Rady Children's Hospital — San Diego, California
- Children's Healthcare of Atlanta — Atlanta, Georgia
- Boston Children's Hospital — Boston, Massachusetts
- University of Michigan Medical Center — Ann Arbor, Michigan
- Washington University at St. Louis — St Louis, Missouri
- Campbell Clinic Orthopaedics — Memphis, Tennessee
- Texas Scottish Rite Hospital — Dallas, Texas
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Clavicle Fracture
- KT Tape for Pediatric Clavicle Fractures — Birmingham, Alabama
- A.L.P.S. Clavicle Plating System PMCF — Weston, Florida
- Comparing Dual Mini-fragment Plating to Single Precontoured Plating of Acute Midshaft Clavicle Fractures Trial — Toronto, Ontario
Explore by condition: All Clavicle Fracture clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.