Comparing two methods for treating humeral shaft fractures in the emergency room
Comparison of Bracing With Co-aptation Splinting for the Initial Treatment of Acute Humeral Shaft Fractures: The COBRAS Trials
This study is testing whether a Sarmiento brace or a coaptation splint works better for helping people with humeral shaft fractures feel more comfortable and recover faster in the emergency room.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 66 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | NYU Langone Health Academic / other |
| Locations | 3 sites (Garden City, New York and 2 other locations) |
| Trial ID | NCT05118087 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of two initial immobilization techniques for acute humeral shaft fractures: the Sarmiento brace and coaptation splinting. Patients presenting with these fractures will be randomly assigned to receive one of the two treatments, and their comfort levels, pain, narcotic usage, and functional outcomes will be monitored over a two-week period. The goal is to determine which method provides better patient-related outcomes and overall comfort during the initial treatment phase.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old with isolated acute humeral shaft fractures who are treated non-operatively.
Not a fit: Patients with open fractures, polytrauma, or those requiring surgical intervention will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved comfort and reduced pain for patients with humeral shaft fractures during their initial treatment.
How similar studies have performed: While there have been studies on humeral fractures, this specific comparison of bracing techniques is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Presenting to an emergency room or ICARE in the participating centers with an acute humeral shaft fracture 2. Age above 18 and skeletally mature 3. Isolated Injury 4. Treated non-operatively first 2 weeks Exclusion Criteria: 1. Open fractures 2. Poly trauma 3. Injuries deemed operative by attending surgeon 4. Patients undergoing treatment for malignancy 5. Prisoners
Where this trial is running
Garden City, New York and 2 other locations
- NYU Winthrop Hospital — Garden City, New York, United States (Not_yet_recruiting)
- NYU Langone Health — New York, New York, United States (Recruiting)
- Jamaica Hospital Medical Center — Queens, New York, United States (Not_yet_recruiting)
Study contacts
- Principal investigator: Abhishek Ganta, MD — NYU Langone Health
- Study coordinator: Abhishek Ganta, MD
- Email: abhishek.ganta@nyulangone.org
- Phone: 718-206-6923
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.