A Prospective Cohort of Displaced Adolescent Midshaft Clavicle Fractures

Study Overview
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Brief Summary
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Outcomes for displaced midshaft clavicle fractures in adolescents are not defined. The current method of treatment for these fractures is non-operative management. There is recent Level 1 evidence in the adult literature to suggest that outcomes are superior when these fractures are managed surgically with open reduction and internal fixation.

Detailed Description
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The study is a prospective observational cohort design of the natural history of adolescent clavicle fractures treated at the McGill University Health Centre. Surgeon choice will dictate treatment. There is no difference from the current normal therapy choice of each individual surgeon. Patients will be offered either operative or conservative management. Operative Treatment: Patients with displaced midshaft clavicle fractures will be offered operative treatment which involves open reduction and internal fixation with a plate. This is the standard treatment for completely displaced fractures in the adult population at our Institution based on Level 1 evidence. Conservative care: Patients will be treated in a sling for the acute phase of two weeks with progressive physiotherapy.

Official Title
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A Prospective Cohort of Displaced Adolescent Midshaft Clavicle Fractures: Are Times to Return to Activities and Functional Outcomes Reasonable for This Population?

Conditions
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Malunion of Fracture of Clavicle, Delayed Union of Fracture of Clavicle

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 12-18 years old The only fracture present in that upper extremity Individual and/or parents able to comply with follow-up Exclusion Criteria: Head injury Prior injury, degenerative condition or congenital condition of the upper extremities Systemic disease that may impair healing Incapable of ensuring follow-up

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 18 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 |
| --- | --- |
| Open reduction internal fixation<br>Patients with displaced midshaft clavicle fractures will be offered operative treatment which involves open reduction and internal fixation. | |
| Conservative care<br>Patients will be treated in a sling for the acute phase of two weeks with progressive physiotherapy. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Malunion and/or non-union in this cohort | Radiographic evaluation | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Times to union (clinical and radiographic) following fracture | Radiologic evaluation | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adolescent, prospective, displaced, clavicle, fracture, mid-shaft