Radiation Therapy for Heterotopic Ossification Prophylaxis Acutely After Elbow Trauma (Elbow HO)
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||Radiation Therapy for Heterotopic Ossification Prophylaxis Acutely After Elbow Trauma|
- The primary radiographic outcome was the presence of heterotopic ossification by plain radiographs of the elbow in the antero-posterior and lateral planes. [ Time Frame: 6 weeks, months 3 and 6 post-operatively ] [ Designated as safety issue: No ]
|Study Start Date:||September 2005|
|Primary Completion Date:||August 2009 (Final data collection date for primary outcome measure)|
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 cGy in a single fraction, using AP-PA fields calculated to midplane. No Less than 6MV 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.
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 (HO) after open reduction internal fixation of intra-articular distal humerus fractures and fracture-dislocations of the elbow and to assess function of the elbow after XRT and no XRT. Patients will be randomly assigned to one of the two groups(XRT/treatment or no XRT/control) by a computer-generated randomization schedule. Assignment will be in a ratio of 1:1 in a complete block design of 10. Each clinical site will be provided with a separate randomization assignment for each study participant. The treating surgeon and patient will be blinded to group assignment until after operative treatment. Clinical and radiographic assessments at 6 weeks, 3 months and 6 months post-operatively will be performed. The primary clinical outcome will be the Mayo elbow performance score which measures pain, stability, function and motion. Motion parameters (flexion, extension, pronation and supination) will be performed at each data collection point. Primary radiographic outcome will be the presence of heterotopic ossification by plain radiographs of the elbow in the antero-posterior and lateral planes at 6 weeks, 3 months, and 6 months post-operatively. Further imaging (radiograph or CT) will be obtained past the 6-month interval if deemed necessary by the treating physician,or if fracture union was not achieved at 6 months. The classification systems described by Brooker et al and Ilahi et al will be used to quantify the presence of HO by radiograph. All adverse events will be documented. The trial will be monitored periodically by the Safety Monitor at least twice a year to ensure protocol compliance and address safety issues.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00991887
|Principal Investigator:||Michael J Bosse, MD||Carolinas Healthcare System|