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

NCT04250415 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 250

Last updated 2025-06-15

No results posted yet for this 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

  • Clavicle Fracture

Interventions

PROCEDURE

Surgery

Sponsors & Collaborators

Principal Investigators

  • Benton E Heyworth, MD · Boston Children's Hospital

Eligibility

Min Age
10 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-03-11
Primary Completion
2026-06-01
Completion
2027-06-01

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04250415 on ClinicalTrials.gov