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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adolescents with displaced clavicle fractures | Adolescents (11 to 17 years old) with displaced clavicle fractures will be enrolled in this study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clavicle fracture injury- observation | Other | 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 |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Strength Measurements | Upper extremity strength measurements, measured by dynamometer (forward flexion, abduction, and external rotation | 6 months and 12 months |
Inclusion Criteria:
Exclusion Criteria:
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11-17 years old with displaced fractures of the middle third of the clavicle
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| Name | Affiliation | Role |
|---|---|---|
| Christopher C Bray, MD | Prisma Health-Upstate | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Greenville Hospital System | Greenville | South Carolina | 29605 | United States |
There are no plans to share IPD
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Feb 11, 2019 | Jan 24, 2020 | ICF_000.pdf |
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| at 3 months, 6 months and 12 months |