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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)

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
No Radiation Therapy (XRT) This group will not receive radiation therapy after surgery.
Radiation Therapy (XRT) 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.

Participant Flow:   Overall Study
    No Radiation Therapy (XRT)   Radiation Therapy (XRT)
STARTED   26   22 
COMPLETED   24   21 
NOT COMPLETED   2   1 
Lost to Follow-up                2                1 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
No Radiation Therapy (XRT) This group will not receive radiation therapy after surgery.
Radiation Therapy (XRT) 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 Total of all reporting groups

Baseline Measures
   No Radiation Therapy (XRT)   Radiation Therapy (XRT)   Total 
Overall Participants Analyzed 
[Units: Participants]
 26   22   48 
Age 
[Units: Participants]
Count of 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 
[Units: Years]
Mean (Standard Deviation)
 45  (15)   44  (17)   45  (17) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      15  57.7%      7  31.8%      22  45.8% 
Male      11  42.3%      15  68.2%      26  54.2% 
Region of Enrollment 
[Units: Participants]
     
United States   26   22   48 


  Outcome Measures

1.  Primary:   Mayo Elbow Performance Score   [ Time Frame: 6 month ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information

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
e-mail: Rachel.Seymour@carolinashealthcare.org



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