NCT04250415

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

Prospective, Multi-Center Adolescent Clavicle Fracture Registry

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 250 (estimated)
• Sponsor: Boston Children's Hospital · Academic / Other
• Sex: All
• Age: 10 Years – 18 Years
• Healthy volunteers: —

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

Type	Name	Description
PROCEDURE	Surgery

Timeline

• Start date: 2013-03-11
• Primary completion: 2026-06-01
• Completion: 2027-06-01
• First posted: 2020-01-31
• Last updated: 2025-06-15

Locations

8 sites across 1 country: United States