Treatment of Pediatric Mid-shaft Clavicle Fractures: A Prospective, Observational Study
NCT ID: NCT03402269
Last Updated: 2023-03-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
30 participants
OBSERVATIONAL
2018-01-10
2022-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Adolescents with displaced clavicle fractures
Adolescents (11 to 17 years old) with displaced clavicle fractures will be enrolled in this study.
Clavicle fracture injury- observation
The study is an observational study with assessments at 1 month, 3 months, 6 months and 1 year following injury. Assessments include range of motion, strength, patient reported outcomes and radiographic healing
Interventions
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Clavicle fracture injury- observation
The study is an observational study with assessments at 1 month, 3 months, 6 months and 1 year following injury. Assessments include range of motion, strength, patient reported outcomes and radiographic healing
Eligibility Criteria
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Inclusion Criteria
* Displaced 100% the width of the clavicle or shortened 1 centimeter
* Operative and non-operative treated clavicles will be eligible for enrollment
Exclusion Criteria
* Ipsilateral shoulder injuries
* Fractures involving the lateral ligaments or the sternoclavicular joint
* Bilateral clavicle fractures
* Pathologic fractures
* Refractures
* Fractures with neurovascular compromise
* Displaced fractures with impending skin compromise
* If there has been more than 21 days between injury and enrollment
* Patients with cognitive disabilities that inhibit the completion of the questionnaires
11 Years
17 Years
ALL
No
Sponsors
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Prisma Health-Upstate
OTHER
Responsible Party
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Principal Investigators
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Christopher C Bray, MD
Role: PRINCIPAL_INVESTIGATOR
Prisma Health-Upstate
Locations
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Greenville Hospital System
Greenville, South Carolina, United States
Countries
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Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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Pro00066019
Identifier Type: -
Identifier Source: org_study_id
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