Radiation Therapy for Heterotopic Ossification Prophylaxis Acutely After Elbow Trauma (NCT00991887) | Clinical Trial Compass
TerminatedNot Applicable
Radiation Therapy for Heterotopic Ossification Prophylaxis Acutely After Elbow Trauma
Stopped: there was an unacceptably high adverse event rate in the treatment group.
48 participantsStarted 2005-09
Plain-language 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 heterotopic ossification.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion Criteria:
* 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 Criteria:
* 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.