Radiation Therapy for Heterotopic Ossification Prophylaxis Acutely After Elbow Trauma

NCT00991887 | Terminated Results DMC

• 1 other identifier: 12-04-09A
• Study Type: interventional
• Target: 48
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Elbow Fracture

Keywords

Heterotopic Ossification; Distal humerus Fracture-dislocations of the elbow; Radiation Therapy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

No Radiation Therapy (XRT)

NO INTERVENTION

This group will not receive radiation therapy after surgery.

Radiation Therapy (XRT)

ACTIVE COMPARATOR

Radiotherapy will be administered no later than 72 hours postoperatively.

Radiation: Radiation Therapy (XRT)

Interventions

Radiation Therapy (XRT) RADIATION

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.

Also known as: Treatment group

Radiation Therapy (XRT)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• Orthopaedic Trauma Association: collaborator
• OrthoCarolina Research Institute, Inc.: collaborator
• Prisma Health-Upstate: collaborator
• Virginia Commonwealth University: collaborator

MeSH Terms

Conditions

Elbow Fractures; Ossification, Heterotopic

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Elbow Injuries; Arm Injuries; Wounds and Injuries; Fractures, Bone; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics

Results Point of Contact

• Title: Rachel Seymour, PhD
• Organization: Carolinas Medical Center

Rachel.Seymour@carolinashealthcare.org

704-355-6969

Study Officials

• Michael J Bosse, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2009
• First Posted: October 8, 2009
• Study Start: September 1, 2005
• Primary Completion: August 1, 2009
• Study Completion: July 1, 2010
• Last Updated: April 21, 2022
• Results First Posted: September 21, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share