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

This study has been terminated.
(there was an unacceptably high adverse event rate in the treatment group.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00991887
First Posted: October 8, 2009
Last Update Posted: September 21, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Orthopaedic Trauma Association
OrthoCarolina Research Institute, Inc.
Greenville Health System
Virginia Commonwealth University
Information provided by (Responsible Party):
Michael Bosse, Carolinas Healthcare System
  Purpose
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.

Condition Intervention
Elbow Fracture Radiation: Radiation Therapy (XRT)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Radiation Therapy for Heterotopic Ossification Prophylaxis Acutely After Elbow Trauma

Resource links provided by NLM:


Further study details as provided by Michael Bosse, Carolinas Healthcare System:

Primary Outcome Measures:
  • Mayo Elbow Performance Score [ Time Frame: 6 month ]
    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).


Enrollment: 48
Study Start Date: September 2005
Study Completion Date: July 2010
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Treatment group

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00991887


Sponsors and Collaborators
Carolinas Healthcare System
Orthopaedic Trauma Association
OrthoCarolina Research Institute, Inc.
Greenville Health System
Virginia Commonwealth University
Investigators
Principal Investigator: Michael J Bosse, MD Carolinas Healthcare System
  More Information

Responsible Party: Michael Bosse, Orthopaedic Traumatologist, Carolinas Healthcare System
ClinicalTrials.gov Identifier: NCT00991887     History of Changes
Other Study ID Numbers: 12-04-09A
First Submitted: October 7, 2009
First Posted: October 8, 2009
Results First Submitted: April 18, 2011
Results First Posted: September 21, 2017
Last Update Posted: September 21, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Michael Bosse, Carolinas Healthcare System:
Heterotopic Ossification
Distal humerus Fracture-dislocations of the elbow
Radiation Therapy

Additional relevant MeSH terms:
Ossification, Heterotopic
Pathologic Processes