MedTrace Logo

Radiation Therapy for Heterotopic Ossification Prophylaxis Acutely After Elbow Trauma

NCT00991887 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2022-04-21

Study results available
· View outcomes & findings →

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

Interventions

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.

Sponsors & Collaborators

  • Orthopaedic Trauma Association

    collaborator OTHER

  • OrthoCarolina Research Institute, Inc.

    collaborator OTHER

  • Prisma Health-Upstate

    collaborator OTHER

  • Virginia Commonwealth University

    collaborator OTHER

  • Wake Forest University Health Sciences

    lead OTHER

Principal Investigators

  • Michael J Bosse, MD · Wake Forest University Health Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2005-09-30
Primary Completion
2009-08-31
Completion
2010-07-31

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00991887 on ClinicalTrials.gov