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

Clavicle Fracture Clinical Trial

Official title:
Prospective, Multi-Center Adolescent Clavicle Fracture Registry

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04250415
Study type Observational [Patient Registry]
Source Boston Children's Hospital
Contact Lauren Hutchinson, MPH
Email Lauren.Hutchinson@childrens.harvard.edu
Status Recruiting
Phase
Start date March 11, 2013
Completion date June 1, 2026
View Details
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