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Multi-Center Adolescent Clavicle Fracture Trial: Operative vs. Non-Operative Treatment
NCT04250415 · View on ClinicalTrials.gov ↗
Study Summary
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.
Conditions Studied
Interventions
- PROCEDURE Surgery
Study Locations (8)
California
- University of California San Francisco Benioff Children's Hospital Oakland — Oakland
- Rady Children's Hospital — San Diego
Georgia
- Children's Healthcare of Atlanta — Atlanta
Massachusetts
- Boston Children's Hospital — Boston
Michigan
- University of Michigan Medical Center — Ann Arbor
Missouri
- Washington University at St. Louis — St Louis
Tennessee
- Campbell Clinic Orthopaedics — Memphis
Texas
- Texas Scottish Rite Hospital — Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 250 participants |
| Start Date | 2013-03-11 |
| Est. Completion | 2027-06-01 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04250415
The ClinicalTrials.gov registry entry for NCT04250415 describes a study currently listed as active not recruiting. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 250 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boston Children's Hospital, which has 752 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Clavicle Fracture appearing as the primary indexed condition, and to 1 intervention — of which Surgery is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04250415 reports 8 study locations spanning 7 distinct geographic areas — top geographies include California, Georgia, Massachusetts. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04250415 about?
NCT04250415 is a clinical study titled "Multi-Center Adolescent Clavicle Fracture Trial: Operative vs. Non-Operative Treatment". 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 measu...
What is the current status of trial NCT04250415?
This trial is currently active not recruiting. The enrollment target is 250 participants. The study started on 2013-03-11. Estimated completion is 2027-06-01.
What conditions does trial NCT04250415 study?
This clinical trial studies the following conditions: Clavicle Fracture. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04250415?
The interventions under investigation include: Surgery (PROCEDURE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04250415?
This trial is sponsored by Boston Children's Hospital, which has 752 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04250415 being conducted?
This trial has 8 study locations across California, Georgia, Massachusetts, Michigan, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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