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

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ClinicalTrials.gov Identifier: NCT00991887
Recruitment Status : Terminated (there was an unacceptably high adverse event rate in the treatment group.)
First Posted : October 8, 2009
Results First Posted : September 21, 2017
Last Update Posted : September 21, 2017
Sponsor:
Collaborators:
Orthopaedic Trauma Association
OrthoCarolina Research Institute, Inc.
Greenville Health System
Virginia Commonwealth University
Information provided by (Responsible Party):
Michael Bosse, Carolinas Healthcare System

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Elbow Fracture
Intervention Radiation: Radiation Therapy (XRT)
Enrollment 48
Recruitment Details  
Pre-assignment Details  
Arm/Group Title No Radiation Therapy (XRT) Radiation Therapy (XRT)
Hide Arm/Group Description This group will not receive radiation therapy after surgery. Radiotherapy will be administered no later than 72 hours postoperatively by a board-certified radiation oncologist. It was given as a single fraction at a dose of 700 cGy at 6-MeV energy photons with use of AP-PA (anteroposterior-posterioanterior) field calculated to midplane, with a mean window of 12x8.2cm, for all patients.
Period Title: Overall Study
Started 26 22
Completed 24 21
Not Completed 2 1
Reason Not Completed
Lost to Follow-up             2             1
Arm/Group Title No Radiation Therapy (XRT) Radiation Therapy (XRT) Total
Hide Arm/Group Description This group will not receive radiation therapy after surgery. Radiotherapy will be administered no later than 72 hours postoperatively by a board-certified radiation oncologist. It was given as a single fraction at a dose of 700 cGy at 6-MeV energy photons with use of AP-PA (anteroposterior-posterioanterior) field calculated to midplane, with a mean window of 12x8.2cm, for all patients. Total of all reporting groups
Overall Number of Baseline Participants 26 22 48
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants 22 participants 48 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
26
 100.0%
22
 100.0%
48
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 26 participants 22 participants 48 participants
45  (15) 44  (17) 45  (17)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants 22 participants 48 participants
Female
15
  57.7%
7
  31.8%
22
  45.8%
Male
11
  42.3%
15
  68.2%
26
  54.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 26 participants 22 participants 48 participants
26 22 48
1.Primary Outcome
Title Mayo Elbow Performance Score
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients with elbow trauma treated with radiation therapy in the prevention of post-traumatic heterotopic ossification. Subjects are randomized to either radiation therapy or no radiation therapy.
Arm/Group Title No Radiation Therapy (XRT) Radiation Therapy (XRT)
Hide Arm/Group Description:
This group will not receive radiation therapy after surgery.
Radiotherapy will be administered no later than 72 hours postoperatively by a board-certified radiation oncologist. It was given as a single fraction at a dose of 700 cGy at 6-MeV energy photons with use of AP-PA (anteroposterior-posterioanterior) field calculated to midplane, with a mean window of 12x8.2cm, for all patients.
Overall Number of Participants Analyzed 24 21
Mean (Standard Deviation)
Unit of Measure: units on a scale
66  (23) 69  (19)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title No Radiation Therapy (XRT) Radiation Therapy (XRT)
Hide Arm/Group Description This group will not receive radiation therapy after surgery. Radiotherapy will be administered no later than 72 hours postoperatively by a board-certified radiation oncologist. It was given as a single fraction at a dose of 700 cGy at 6-MeV energy photons with use of AP-PA (anteroposterior-posterioanterior) field calculated to midplane, with a mean window of 12x8.2cm, for all patients.
All-Cause Mortality
No Radiation Therapy (XRT) Radiation Therapy (XRT)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
No Radiation Therapy (XRT) Radiation Therapy (XRT)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/24 (0.00%)      0/21 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
No Radiation Therapy (XRT) Radiation Therapy (XRT)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/24 (16.67%)      8/21 (38.10%)    
Musculoskeletal and connective tissue disorders     
Fracture Nonunion   4/24 (16.67%)  4 8/21 (38.10%)  8
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Rachel Seymour, PhD
Organization: Carolinas Medical Center
Phone: 704-355-6969
Responsible Party: Michael Bosse, 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