Comparison of Bracing With Co-aptation Splinting for the Initial Treatment of Acute Humeral Shaft Fractures: The COBRAS Trials
NCT ID: NCT05118087
Last Updated: 2025-04-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
66 participants
INTERVENTIONAL
2021-07-20
2027-07-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Coaptation Splint
Webril Padded Plaster Splint
Patients in the coaptation splint group will have a webril padded plaster splint that is placed around the humerus. The forearm and wrist are then suspended in a cuff and collar.
Sarmiento Brace
Pre-Fabricated Fracture Brace
Patients in the sarmiento group will be given a fitted pre-fabricated fracture brace with a cuff and collar for the forearm. The patients will be educated on brace maintained, tightening, and care during at the time of the ER encounter.
Interventions
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Webril Padded Plaster Splint
Patients in the coaptation splint group will have a webril padded plaster splint that is placed around the humerus. The forearm and wrist are then suspended in a cuff and collar.
Pre-Fabricated Fracture Brace
Patients in the sarmiento group will be given a fitted pre-fabricated fracture brace with a cuff and collar for the forearm. The patients will be educated on brace maintained, tightening, and care during at the time of the ER encounter.
Eligibility Criteria
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Inclusion Criteria
2. Age above 18 and skeletally mature
3. Isolated Injury
4. Treated non-operatively first 2 weeks
Exclusion Criteria
2. Poly trauma
3. Injuries deemed operative by attending surgeon
4. Patients undergoing treatment for malignancy
5. Prisoners
18 Years
ALL
No
Sponsors
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NYU Langone Health
OTHER
Responsible Party
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Principal Investigators
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Abhishek Ganta, MD
Role: PRINCIPAL_INVESTIGATOR
NYU Langone Health
Locations
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NYU Winthrop Hospital
Garden City, New York, United States
NYU Langone Health
New York, New York, United States
Jamaica Hospital Medical Center
Queens, New York, United States
Countries
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Central Contacts
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Facility Contacts
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Meelan Patel, MD
Role: primary
Other Identifiers
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21-00438
Identifier Type: -
Identifier Source: org_study_id
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