Radiation Therapy for Heterotopic Ossification Prophylaxis Acutely After Elbow Trauma (ElbowHO)

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 Overview

• Status: Terminated
• Conditions: Elbow Fracture
• Intervention / Treatment: Radiation: Radiation Therapy (XRT)

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.

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: Treatment group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	6 month

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Collaborators: OrthoCarolina Research Institute, Inc.; Virginia Commonwealth University; Orthopaedic Trauma Association; Prisma Health-Upstate
• Investigators: Principal Investigator: Michael J Bosse, MD, Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start: September 1, 2005
• Primary Completion (Actual): August 1, 2009
• Study Completion (Actual): July 1, 2010

Study Registration Dates

• First Submitted: October 7, 2009
• First Submitted That Met QC Criteria: October 7, 2009
• First Posted (Estimate): October 8, 2009

Study Record Updates

• Last Update Posted (Actual): April 21, 2022
• Last Update Submitted That Met QC Criteria: April 19, 2022
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Keywords: Radiation Therapy; Heterotopic Ossification; Distal humerus Fracture-dislocations of the elbow
• Additional Relevant MeSH Terms: Pathologic Processes; Ossification, Heterotopic
• Other Study ID Numbers: 12-04-09A

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No