Status:
COMPLETED
Conservative Treatment Versus Operative Plate Fixation for Acute, Displaced Fractures of the Distal Clavicle
Lead Sponsor:
Unity Health Toronto
Collaborating Sponsors:
Fraser Health
University of British Columbia
Conditions:
Clavicle Fracture
Fractures
Eligibility:
All Genders
16-60 years
Phase:
NA
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.
Eligibility Criteria
Inclusion
- 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
- 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.)
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2019
Estimated Enrollment :
59 Patients enrolled
Trial Details
Trial ID
NCT00872105
Start Date
March 1 2009
End Date
September 1 2019
Last Update
November 27 2019
Active Locations (1)
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1
St. Michael's Hospital
Toronto, Ontario, Canada, M5C 1R6