Status:
RECRUITING
Comparing Dual Mini-fragment Plating to Single Precontoured Plating of Acute Midshaft Clavicle Fractures Trial
Lead Sponsor:
Sunnybrook Health Sciences Centre
Collaborating Sponsors:
Canadian Orthopaedic Trauma Society
Conditions:
Clavicle Fracture
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
The rate of surgical fixation of fractures of the collarbone (i.e., midshaft clavicle) has exponentially increased in recent years; however, the rate of repeat procedures for removal of these implants...
Detailed Description
Midshaft clavicle fractures have traditionally been treated non-operatively with immobilization in a sling or a figure-of-eight bandage. Early studies reported a non-union rate of 1% and negligible fu...
Eligibility Criteria
Inclusion
- Between 18 and 65 years of age
- A completely displaced midshaft fracture of the clavicle (no cortical contact between the main proximal and distal fragments (AO/OTA 15.2A/B/C)
- Fracture amenable to plate fixation with a minimum of three screws in each proximal and distal fragment
Exclusion
- Open fracture
- Pathological fracture
- Fracture seen \> 28 days after injury
- Associated neurovascular injury
- Associated head injury (Glasgow Coma Scale \< 12)
- Concomitant ipsilateral upper extremity fracture
- Significant medical comorbidities (i.e., ASA grade IV and V)
- Inability to comply with follow-up and
- Lack of consent
Key Trial Info
Start Date :
April 4 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2028
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT05231343
Start Date
April 4 2022
End Date
January 1 2028
Last Update
May 24 2023
Active Locations (1)
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1
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5