Clinical trial NCT00991887: Radiation Therapy for Heterotopic Ossification Prophylaxis Acutely After Elbow Trauma
Official title: Radiation Therapy for Heterotopic Ossification Prophylaxis Acutely After Elbow Trauma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Elbow Fracture
Keywords: Heterotopic Ossification
Distal humerus Fracture-dislocations of the elbow
Radiation Therapy
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: Orthopaedic Trauma Association
name: OrthoCarolina Research Institute, Inc.
name: Prisma Health-Upstate
name: Virginia Commonwealth University
First posted: 2009-10-08
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 heterotopic ossification.

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 (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.

Eligibility criteria: 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.

Primary outcomes:
measure: Mayo Elbow Performance Score
timeFrame: 6 month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Wake Forest University Health Sciences
name: Michael J Bosse, MD
role: PRINCIPAL_INVESTIGATOR
References: