Actively Recruiting
Comparing Dual Mini-fragment Plating to Single Precontoured Plating of Acute Midshaft Clavicle Fractures Trial
Led by Sunnybrook Health Sciences Centre · Updated on 2023-05-24
66
Participants Needed
1
Research Sites
299 weeks
Total Duration
On this page
Sponsors
S
Sunnybrook Health Sciences Centre
Lead Sponsor
C
Canadian Orthopaedic Trauma Society
Collaborating Sponsor
AI-Summary
What this Trial Is About
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 (i.e., plates) due to irritation remains high. Despite technological advances in implant design, nearly one in four patients with a surgically fixed collarbone ultimately undergoes removal of their implant. More recently, there has been a growing body of literature demonstrating the effectiveness of using two smaller caliber plates, which have been found to have similar rates of implant removal. As such, the proposed randomized clinical trial seeks to be the first level I study to directly compare dual mini-fragment plating of acute displaced midshaft clavicle fractures to single precontoured plating. The investigators hypothesize that dual mini-fragment plating will result in lower rates of reoperation with similar rates of union and complication.
CONDITIONS
Official Title
Comparing Dual Mini-fragment Plating to Single Precontoured Plating of Acute Midshaft Clavicle Fractures Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Between 18 and 65 years of age
- Completely displaced midshaft clavicle fracture with no cortical contact between main proximal and distal fragments (AO/OTA 15.2A/B/C)
- Fracture suitable for plate fixation with at least three screws in both proximal and distal fragments
You will not qualify if you...
- Open fracture
- Pathological fracture
- Fracture seen more than 28 days after injury
- Associated neurovascular injury
- Associated head injury with Glasgow Coma Scale less than 12
- Concomitant fracture of the same-side upper extremity
- Significant medical comorbidities (ASA grade IV and V)
- Inability to comply with follow-up
- Lack of consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
Actively Recruiting
Research Team
S
Sara Aman, BSc
CONTACT
K
Katrine Milner, BSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here