Status:
COMPLETED
Operative and Nonoperative Treatment of Humeral Shaft Fractures
Lead Sponsor:
McGill University Health Centre/Research Institute of the McGill University Health Centre
Collaborating Sponsors:
Canadian Orthopaedic Trauma Society
Conditions:
Humeral Diaphyseal Fracture
Eligibility:
All Genders
18-90 years
Phase:
NA
Brief Summary
The purpose of this research study is to compare two different ways of treating a broken arm (fractured humerus) using either, the nonoperative approach or the operative, open reduction and internal f...
Detailed Description
Fractures of the humeral diaphysis occur in a bimodal distribution and represent 3-5% of all fractures. Overall the incidence is higher in women and typically presents at a more advanced age in this p...
Eligibility Criteria
Inclusion
- Over 18 y/o with skeletal maturity, and consenting to participate
- A displaced fracture of the humeral diaphysis amenable to fixation with a plate with no other injuries to the same limb
- 21 days or less between injury and surgery
- Medically fit for anaesthesia
- The mental faculties to participate in post-op evaluation
- Fracture amenable to both treatment methods
Exclusion
- Open fracture
- Neurovascular injury requiring repair in the same limb (excluding radial nerve palsy)
- Active infection in the area of the surgical approach
- Prior injury, degenerative condition, or congenital condition to the shoulder, arm or elbow
- Bone disorder which may impair bone healing
- Polytrauma with other limb fractures
- Incapable of ensuring follow-up
- Pathologic fracture
- Already enrolled in another research clinical trial
Key Trial Info
Start Date :
August 19 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2023
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT00878319
Start Date
August 19 2009
End Date
February 1 2023
Last Update
February 14 2025
Active Locations (1)
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1
McGill University Health Centre - Montreal General Hospital
Montreal, Quebec, Canada, H3G 1A4