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| Name | Class |
|---|---|
| Fraser Health | OTHER |
| University of British Columbia | OTHER |
| London Health Sciences Centre | OTHER |
| University of Calgary |
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This is a multicentre randomized clinical trial prospectively comparing operative treatment versus conservative (nonoperative) care in the management of displaced distal (Type II) clavicle fractures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non-operative treatment | Other | The first treatment strategy will involve conservative (nonoperative) management of the clavicle fracture. |
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| Operative treatment | Active Comparator | The second treatment strategy will involve operative fixation (i.e. ORIF) of the fracture with a plate and screws. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-operative Treatment | Procedure | Standard protocol for conservative treatment will consist of the implementation of a sling, for clavicular support and patient comfort. Pendulum or gentle Range of Motion (ROM) shoulder exercises may be implemented at any time as dictated by the attending surgeon. |
| Measure | Description | Time Frame |
|---|---|---|
| The primary outcome measurement will be patient DASH (Disabilities of the Arm, Shoulder and Hand Instrument) scores. The DASH is a patient-oriented, limb-specific, functional measurement questionnaire. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| The secondary outcome measurement patients' functional shoulder scores as defined by Constant's Shoulder Score (i.e. pain, activities of daily living, range of motion and power). | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeremy A Hall, MD, FRCS(C) | Unity Health Toronto | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Michael's Hospital | Toronto | Ontario | M5C 1R6 | Canada |
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| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| OTHER |
| Nova Scotia Health Authority | OTHER |
| Winnipeg Regional Health Authority | OTHER |
| McGill University Health Centre/Research Institute of the McGill University Health Centre | OTHER |
| The Ottawa Hospital | OTHER |
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| Operative Treatment | Procedure | The operating surgeon will determine the positioning of the patient for surgery. ORIF of the distal clavicle fracture will be carried out as follows: Anatomic reduction of the fracture Definitive fixation with a contoured clavicle plate and screws; a AO hook plate; a 3.5 LCDC, reconstruction, or compression plate is acceptable; a 1/3 tubular plate is not acceptable Use of bone graft is optional (iliac crest bone autograft) |
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