Radiation Therapy for Heterotopic Ossification Prophylaxis Acutely After Elbow Trauma (ElbowHO)
Primary Purpose
Elbow Fracture
Status
Terminated
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Radiation Therapy (XRT)
Sponsored by
About this trial
This is an interventional treatment trial for Elbow Fracture focused on measuring Heterotopic Ossification, Distal humerus Fracture-dislocations of the elbow, Radiation Therapy
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
No Radiation Therapy (XRT)
Radiation Therapy (XRT)
Arm Description
This group will not receive radiation therapy after surgery.
Radiotherapy will be administered no later than 72 hours postoperatively.
Outcomes
Primary Outcome Measures
Mayo Elbow Performance Score
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).
Secondary Outcome Measures
Full Information
NCT ID
NCT00991887
First Posted
October 7, 2009
Last Updated
April 19, 2022
Sponsor
Wake Forest University Health Sciences
Collaborators
Orthopaedic Trauma Association, OrthoCarolina Research Institute, Inc., Prisma Health-Upstate, Virginia Commonwealth University
1. Study Identification
Unique Protocol Identification Number
NCT00991887
Brief Title
Radiation Therapy for Heterotopic Ossification Prophylaxis Acutely After Elbow Trauma
Acronym
ElbowHO
Official Title
Radiation Therapy for Heterotopic Ossification Prophylaxis Acutely After Elbow Trauma
Study Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Terminated
Why Stopped
there was an unacceptably high adverse event rate in the treatment group.
Study Start Date
September 2005 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
July 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
Collaborators
Orthopaedic Trauma Association, OrthoCarolina Research Institute, Inc., Prisma Health-Upstate, Virginia Commonwealth University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Elbow Fracture
Keywords
Heterotopic Ossification, Distal humerus Fracture-dislocations of the elbow, Radiation Therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
No Radiation Therapy (XRT)
Arm Type
No Intervention
Arm Description
This group will not receive radiation therapy after surgery.
Arm Title
Radiation Therapy (XRT)
Arm Type
Active Comparator
Arm Description
Radiotherapy will be administered no later than 72 hours postoperatively.
Intervention Type
Radiation
Intervention Name(s)
Radiation Therapy (XRT)
Other Intervention Name(s)
Treatment group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Mayo Elbow Performance Score
Description
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).
Time Frame
6 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael J Bosse, MD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Radiation Therapy for Heterotopic Ossification Prophylaxis Acutely After Elbow Trauma
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