Treatment of Pediatric Mid-shaft Clavicle Fractures: A Prospective, Observational Study

Study Overview
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Brief Summary
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Clavicle fractures in children are common. Typical treatment includes nonoperative treatment with a sling. Operative treatment is usually limited to open, unstable, fractures with either epidermal risks or neurovascular compromise. Orthopaedic literature has many studies that report the need for additional research for this prevalent fracture. This is an observational study evaluating the functional and patient reported outcomes of displaced clavicle fractures in adolescents. The results from this study will help the orthopedist understand the expected outcomes for a given pediatric patient with a clavicle fracture.

Official Title
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Treatment of Pediatric Mid-shaft Clavicle Fractures: A Prospective, Observational Study

Conditions
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Clavicle Fracture, Adolescent

Intervention / Treatment
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* Other: Clavicle fracture injury- observation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 11-17 years old with fractures of the middle third of the clavicle Displaced 100% the width of the clavicle or shortened 1 centimeter Operative and non-operative treated clavicles will be eligible for enrollment Exclusion Criteria: Open clavicle fractures 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

Ages Eligible for Study
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Minimum Age: 11 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Adolescents with displaced clavicle fractures<br>Adolescents (11 to 17 years old) with displaced clavicle fractures will be enrolled in this study. | Other: Clavicle fracture injury- observation<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Range of motion | Range of motion measured by goniometer | at 1 year post injury | 
| Radiographic healing | Radiographic evidence of healing on 3 of 4 cortices | at 1 year post injury | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| QuickDash | QuickDash Outcome Measure- measuring patient reported disability of arm, shoulder and hand | at 3 months, 6 months and 12 months | 
| PODCI | Adolescent Pediatric Outcomes Data Collection Instrument - measuring patient reported outcomes in a pediatric population | at 3 months, 6 months and 12 months |