Fractures Clinical Trial
Official title:
A Multicentre, Randomized Trial of Conservative Treatment Versus Operative Plate Fixation for Acute, Displaced Fractures of the Distal Clavicle
Verified date | November 2019 |
Source | St. Michael's Hospital, Toronto |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 59 |
Est. completion date | September 2019 |
Est. primary completion date | December 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 16 Years to 60 Years |
Eligibility |
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.) |
Country | Name | City | State |
---|---|---|---|
Canada | St. Michael's Hospital | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
St. Michael's Hospital, Toronto | Fraser Health, London Health Sciences Centre, McGill University Health Centre/Research Institute of the McGill University Health Centre, Nova Scotia Health Authority, The Ottawa Hospital, University of British Columbia, University of Calgary, Winnipeg Regional Health Authority |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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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