Radiation Therapy for Heterotopic Ossification Prophylaxis Acutely After

Status Terminated

Clinical Trial 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.

Clinical Trial 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 (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 presence of HO will be quantified 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00991887
Study type	Interventional
Source	Wake Forest University Health Sciences
Contact
Status	Terminated
Phase	N/A
Start date	September 2005
Completion date	July 2010

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Radiation Therapy for Heterotopic Ossification Prophylaxis Acutely After Elbow Trauma — ElbowHO

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms