Status:
TERMINATED
Radiation Therapy for Heterotopic Ossification Prophylaxis Acutely After Elbow Trauma
Lead Sponsor:
Wake Forest University Health Sciences
Collaborating Sponsors:
Orthopaedic Trauma Association
OrthoCarolina Research Institute, Inc.
Conditions:
Elbow Fracture
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
The investigators hypothesized that radiation therapy could be safely administered acutely after elbow trauma, and it would decrease the number of patients that would require surgical excision of hete...
Detailed Description
A multi-institutional, prospective randomized clinical trial will be employed to determine if single dose, limited field radiation therapy (XRT) will prevent post-traumatic heterotopic ossification (H...
Eligibility Criteria
Inclusion
- Skeletally mature patients with minimum age of 18 years and maximum age of 65.
- Patients deemed appropriate for operative intervention by the treating physician.
- Distal humerus intra-articular fractures (types 13-C1, C2, and C3), with or without proximal radius/ulna fractures - open or closed.
- Fracture-dislocations of the elbow (ulno-humeral dislocation associated with proximal ulna and/or radius fractures) - open or closed.
Exclusion
- Head injury, quantified by Glasgow Coma Score (GCS) \< 13 at time of consent for operative intervention.
- Burns \> 20% Total Body Area (TBA) or involving the operative site.
- Patients with spinal cord injury affecting the upper extremities will be excluded.
- Open fractures which cannot be closed primarily within 72 hours of initial operative intervention.
- Patients with estimated life expectancy of less than one year due to preexisting condition.
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2010
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT00991887
Start Date
September 1 2005
End Date
July 1 2010
Last Update
April 21 2022
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