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NCT04250415 · ClinicalTrials.gov registry record
Multi-Center Adolescent Clavicle Fracture Trial: Operative vs. Non-Operative Treatment
A clinical trial of Clavicle Fracture, sponsored by Boston Children's Hospital.
- Active
- Registry status
- 250
- Enrollment target
- 8
- Study locations
NCT04250415 is a study of Clavicle Fracture that is active but no longer recruiting, run by Boston Children's Hospital. The registered enrollment target is 250 participants. The trial reports 8 study locations across 7 states.
The verdict
NCT04250415, a study of Clavicle Fracture, is active but no longer recruiting, sponsored by Boston Children's Hospital.
- ACTIVE NOT RECRUITING
- Registry status
- 250 participants
- Enrollment target
- 8
- Study locations
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, categorized as an unspecified phase. 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 462 total studies on file at ClinicalTrials.gov.
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.
NCT04250415 reports 8 study locations spanning 7 distinct geographic areas - top geographies include California, Georgia, Massachusetts.
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.
What interventions are being tested in trial NCT04250415?
The interventions under investigation include: Surgery (PROCEDURE).
Who is sponsoring clinical trial NCT04250415?
This trial is sponsored by Boston Children's Hospital, which has 462 total clinical trials registered on ClinicalTrials.gov.
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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