Radiation Therapy for Heterotopic Ossification Prophylaxis Acutely After Elbow Trauma (ElbowHO)
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|ClinicalTrials.gov Identifier: NCT00991887|
Recruitment Status : Terminated (there was an unacceptably high adverse event rate in the treatment group.)
First Posted : October 8, 2009
Results First Posted : September 21, 2017
Last Update Posted : September 21, 2017
|Condition or disease||Intervention/treatment||Phase|
|Elbow Fracture||Radiation: Radiation Therapy (XRT)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||48 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Radiation Therapy for Heterotopic Ossification Prophylaxis Acutely After Elbow Trauma|
|Study Start Date :||September 2005|
|Actual Primary Completion Date :||August 2009|
|Actual Study Completion Date :||July 2010|
No Intervention: No Radiation Therapy (XRT)
This group will not receive radiation therapy after surgery.
Active Comparator: Radiation Therapy (XRT)
Radiotherapy will be administered no later than 72 hours postoperatively.
Radiation: Radiation Therapy (XRT)
The dose will be 700 gray (derived unit of ionizing radiation dose in the International System of Units) in a single fraction, using AP-PA fields calculated to midplane. No Less than 6 MV energy photons will be used, and no bolus is placed on the skin. The field covers the entire joint, the antecubital fossa and the olecranon process. A strip of skin at the antecubital area is generally shielded, but is not an absolute requirement for this study.
Other Name: Treatment group
- Mayo Elbow Performance Score [ Time Frame: 6 month ]Mayo Elbow Performance Score (MEPS) is an outcome tool based on a 100 point scale, with higher score indicating better function. It measures pain, stability, function, and motion. The score is graded on the basis of the MEPS as excellent (>=90), good (75-89), fair (60-74), and poor (<60).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00991887
|Principal Investigator:||Michael J Bosse, MD||Carolinas Healthcare System|