Clavicle Fracture, Fractures
Conditions
Keywords
clavicle, fractures, distal
Brief summary
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.
Interventions
PROCEDURENon-operative Treatment
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.
PROCEDUREOperative Treatment
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)
Sponsors
Fraser Health
University of British Columbia
London Health Sciences Centre
University of Calgary
Nova Scotia Health Authority
Winnipeg Regional Health Authority
McGill University Health Centre/Research Institute of the McGill University Health Centre
The Ottawa Hospital
Unity Health Toronto
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Men or women aged 16 to 60 years of age * Completely displaced (no cortical contact), closed fracture of the distal 3rd of the clavicle (Type II) confirmed by radiograph * Fractures within 28 days post injury * Provision of informed consent
Exclusion criteria
* Pathological fractures * Non-displaced (cortical contact) distal clavicle fractures * Open clavicle fractures * Presence of vascular injury * Fractures more than 28 days post-injury * Limited life expectancy due to significant medical co-morbidity * Medical contraindication to surgery * Inability to comply with rehabilitation or form completion * Likely problems, in the judgement of the investigators, with maintaining follow-up (i.e. patients with no fixed address, patients not mentally competent to give consent, etc.)
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | 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 |
Countries
Canada
Outcome results
None listed