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| Name | Class |
|---|---|
| Unity Health Toronto | OTHER |
| Winnipeg Regional Health Authority | OTHER |
| Thunder Bay Regional Health Sciences Centre | OTHER |
| Montreal General Hospital |
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This prospective, multi-centre study aims to determine clinical, radiographic, and patient-reported outcomes (PROMs) following surgical fixation of displaced mid-diaphyseal clavicle fractures and to compare implant removal rates between techniques within 2-years of the procedure.
Given the substantially lower implant removal rate in combination with a high union rate with the dual mini-fragment technique, we do not believe there is clinical equipoise required for a randomized clinical trial.
This study is a multi-centre, prospective cohort study (11 sites confirmed to date) of all operatively treated clavicle fractures, in order to objectively evaluate all current surgical techniques used across Canada. This pragmatic approach will allow us to observe surgical decision-making, rationale for implant removal, and report on clinical, radiographic, and patient-reported outcomes for all techniques over a 2-year follow-up timeframe, for the first time.
All enrolled patients will be encouraged to begin immediate range of motion as tolerated and weightbearing as tolerated post-operatively. This will be assessed at each follow-up and any reason for delayed motion or weightbearing will be reported.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| surgical fixation | Procedure | compare implant removal rates between surgical fixation techniques. |
| Measure | Description | Time Frame |
|---|---|---|
| Determine implant removal rates | To report implant removal rates in an appropriately powered prospective cohort study. | 4 years |
| Identify rationale for implant removal | To report rationale for implant removal in an appropriately powered prospective cohort study. | 4 years |
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Inclusion Criteria:
Exclusion Criteria:
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Skeletally mature, adult participants aged 18 years of age or older, who are treated with surgical fixation for a displaced mid-diaphyseal clavicle fracture. Exclusion criteria: Pathological fractures, clavicle non-unions, current or prior ipsilateral upper extremity injury that may impact functional outcomes, or an inability to consent or complete follow-up.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Foothills Medical Centre | Recruiting | Calgary | Alberta | T2N 5A1 | Canada |
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| ID | Term |
|---|---|
| D053831 | Surgical Fixation Devices |
| ID | Term |
|---|---|
| D013523 | Surgical Equipment |
| D004864 | Equipment and Supplies |
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| OTHER |
| Queen Elizabeth II Health Sciences Centre | OTHER |
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