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HO Prophylaxis Therapy for Distal Humerus Fractures

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03724422
Recruitment Status : Recruiting
First Posted : October 30, 2018
Last Update Posted : March 26, 2020
Sponsor:
Information provided by (Responsible Party):
Rodolfo Zamora, MD, University of Louisville

Brief Summary:
To determine the effectiveness of 500 cGy dose of radiation therapy vs. an untreated group in the prophylactic treatment of heterotopic ossification in distal humerus fractures

Condition or disease Intervention/treatment Phase
Heterotopic Ossification Humeral Fractures Radiation Therapy Radiation: Radiation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants will be randomized to either a treatment or control group.
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Prophylaxis Low-Dose Radiation Therapy for Heterotopic Ossification in Distal Humerus Fractures
Actual Study Start Date : October 9, 2019
Estimated Primary Completion Date : October 30, 2021
Estimated Study Completion Date : April 30, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Control
This group will receive the standard of care treatment for their distal humerus fracture only.
Experimental: Intervention
This group will receive the prophylactic radiation therapy in addition to the standard of care treatment of their distal humerus fracture.
Radiation: Radiation
A dose of 500cGy will be delivered in 1 fraction to the isocenter. Radiation will be administered no later than 72 hours postoperatively




Primary Outcome Measures :
  1. Presence of HO on humerus. [ Time Frame: 1 year. ]
    Presence of heterotopic ossification on plain radiographs taken in the anteroposterior and lateral planes within 1 year after surgery as quantified using the classification systems described by Brooker, et al. and Hastings and Graham


Secondary Outcome Measures :
  1. Non-union at the fracture site. [ Time Frame: 1 year post surgical reduction. ]
    Rate of non-union of both groups requiring revision surgery.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patient has a distal humerus fracture.
  2. Patient's age is greater than or equal to 18

Exclusion Criteria:

  1. Patient has a concomitant proximal ulna and/or proximal radius fracture
  2. Patient requires external fixation of the elbow
  3. Patient has quadriplegia or paraplegia
  4. Patient requires intubation upon admission or for >4 hours during admission for nonsurgical purposes
  5. Patient has concomitant soft tissue damage in the affected elbow that cannot be appropriately closed within 72 hours of surgery
  6. Patient has a burn affecting greater than or equal to 20% of the total body surface area or on the affected elbow
  7. Patient has pre-existing heterotopic ossification in the affected elbow.
  8. Patient is pregnant.

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): NCT03724422


Contacts
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Contact: Rodolfo Zamora, MD 502-629-5460 razamo02@louisville.edu
Contact: John E Whitaker, BS 5029191864 john.whitaker1616@gmail.com

Locations
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United States, Kentucky
University of Louisville Hospital Recruiting
Louisville, Kentucky, United States, 40202
University of Louisville Hospital Recruiting
Louisville, Kentucky, United States, 40228
Contact: Rodolfo Zamora, MD    502-629-5460    razamo02@louisville.edu   
Contact: Salwa Rashid, MD, MPH    502-794-4964    sfrash01@louisville.edu   
Sponsors and Collaborators
University of Louisville
Investigators
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Principal Investigator: Rodolfo Zamora, MD University of Louisville
Publications:

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Responsible Party: Rodolfo Zamora, MD, Assistant Professor of Orthopaedic Surgery, University of Louisville
ClinicalTrials.gov Identifier: NCT03724422    
Other Study ID Numbers: IRB Number:18.0184
First Posted: October 30, 2018    Key Record Dates
Last Update Posted: March 26, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No plan at this time to Share IPD

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Rodolfo Zamora, MD, University of Louisville:
Herteropic Ossification
Additional relevant MeSH terms:
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Ossification, Heterotopic
Fractures, Bone
Humeral Fractures
Wounds and Injuries
Arm Injuries
Pathologic Processes