Trials / Completed
CompletedNCT03415958
A Prospective Cohort of Displaced Adolescent Midshaft Clavicle Fractures
A Prospective Cohort of Displaced Adolescent Midshaft Clavicle Fractures: Are Times to Return to Activities and Functional Outcomes Reasonable for This Population?
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 49 (actual)
- Sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre · Academic / Other
- Sex
- All
- Age
- 12 Years – 18 Years
- Healthy volunteers
- Not accepted
Summary
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
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.
Conditions
Timeline
- Start date
- 2012-03-28
- Primary completion
- 2015-10-31
- Completion
- 2016-10-31
- First posted
- 2018-01-30
- Last updated
- 2018-01-30
Locations
1 site across 1 country: Canada
Source: ClinicalTrials.gov record NCT03415958. Inclusion in this directory is not an endorsement.