Humeral FracturesNCT05118087
Comparison of Bracing With Co-aptation Splinting for the Initial Treatment of Acute Humeral Shaft Fractures: The COBRAS Trials
A study testing Webril Padded Plaster Splint and Pre-Fabricated Fracture Brace in people with Humeral Fractures, run by NYU Langone Health at 3 sites in United States.
Trial summary
The goal of this study is to determine which initial method of immobilization for humeral shaft fractures in the emergency room maximizes patient comfort. The two methods of initial management for humeral shaft fractures are sarmiento bracing (pre-fabricated fracture brace) and coaptation splinting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Humeral Fractures
- What is being tested?
- Webril Padded Plaster Splint and Pre-Fabricated Fracture Brace
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 3 sitesUnited States
- Study dates
- 20 Jul 2021to 1 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Presenting to an emergency room or ICARE in the participating centers with an acute humeral shaft fracture
- Age above 18 and skeletally mature
- Isolated Injury
- Treated non-operatively first 2 weeks
Who cannot join
- Open fractures
- Poly trauma
- Injuries deemed operative by attending surgeon
- Patients undergoing treatment for malignancy
- Prisoners
Trial locations and contacts
3 sites in 1 country.
United States3 sites
NYU Winthrop Hospital
Garden City, New York, 11530
NYU Langone Health
New York, New York, 10016
Jamaica Hospital Medical Center
Queens, New York, 11418
About this study
The goal of this study is to determine which initial method of immobilization for humeral shaft fractures in the emergency room maximizes patient comfort. The two methods of initial management for humeral shaft fractures are sarmiento bracing (pre-fabricated fracture brace) and coaptation splinting. In this study, the team will compare patient related outcomes and comfort for each method of initial management of humeral shaft fractures. Participant pain, narcotic usage, and function will be tracked over a 2 week period to see which method of immobilization is preferred.
- Conditions
- Humeral Fractures
- Being tested
- Webril Padded Plaster Splint, Pre-Fabricated Fracture Brace
- Keywords
- Sarmiento Brace, Coaptation Splint
- Medical subject headings
- Humeral Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Webril Padded Plaster SplintProcedure or surgery
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 BraceProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Coaptation Splint | Active comparator | Not described Receives: Procedure: Webril Padded Plaster Splint |
| Sarmiento Brace | Active comparator | Not described Receives: Procedure: Pre-Fabricated Fracture Brace |
What is being measured
The primary outcome is the main question the study is designed to answer.
Score on Pain Visual Analogue Scale (VAS)
The Visual Analog Scale (VAS) is a 10 cm line with anchor statements on the left (no pain) and on the right (extreme pain). The patient is asked to mark their current pain level on the line. The total range of score is 0 (no pain) to 10 (unbearable pain); the higher the pain, the greater the amount of pain.
Measured: Week 1 post-treatment
Score on Pain Visual Analogue Scale (VAS)
The Visual Analog Scale (VAS) is a 10 cm line with anchor statements on the left (no pain) and on the right (extreme pain). The patient is asked to mark their current pain level on the line. The total range of score is 0 (no pain) to 10 (unbearable pain); the higher the pain, the greater the amount of pain.
Measured: Week 2 post-treatment
Number of Tramadol Pills Taken
All patients will be discharged with 28 pills of tramadol 50mg. At week 1 follow-up, number of tramadol pills taken will be reported.
Measured: Week 1 post-treatment
Number of Tramadol Pills Taken
All patients will be discharged with 28 pills of tramadol 50mg. At week 2 follow-up, number of tramadol pills taken will be reported.
Measured: Week 2 post-treatment
Secondary outcomes (3)
Incidence of cutaneous complications
Cutaneous complications between immediate fracture bracing and coaptation splints in the ER within the first 2 weeks of treatment will be reported
Measured: Week 2 post-treatment
Score on PROMIS - Physical Function - Short Form 10b
PROMIS consists of 10 statements/questions that are scored 1-5 each. The total range of score is 10-50; a higher score indicates less difficulty performing an activity.
Measured: Week 1 post-treatment
Score on PROMIS - Physical Function - Short Form 10b
PROMIS consists of 10 statements/questions that are scored 1-5 each. The total range of score is 10-50; a higher score indicates less difficulty performing an activity.
Measured: Week 2 post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2021
- Study start20 Jul 2021
- Primary completion1 Oct 2025
- Study completion1 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Humeral FracturesStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Abhishek Ganta, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05118087
- Sponsor's protocol ID
- 21-00438
- Status last verified
- Feb 2026
- First submitted
- 1 Nov 2021
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be available upon reasonable request.
Publications
Kingery MT, Ganta A, Egol KA. Comparison of Early Bracing Versus Splinting for the Initial Treatment of Acute Humeral Shaft Fractures (The COBRAS Trial). J Orthop Trauma. 2026 Aug 1;40(8):408-415. doi: 10.1097/BOT.0000000000003196.
PubMed 42466769
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Bracing With Co-aptation Splinting for the Initial Treatment of Acute Humeral Shaft Fractures: The COBRAS Trials
- ClinicalTrials.gov ID
- NCT05118087
- Acronym / sponsor ID
- 21-00438
- Conditions
- Humeral Fractures
- Keywords
- Sarmiento Brace, Coaptation Splint
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 20 Jul 2021 (actual)
- Primary completion
- 1 Oct 2025 (actual)
- Study completion
- 1 Nov 2025 (actual)
- First posted
- 11 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to determine which initial method of immobilization for humeral shaft fractures in the emergency room maximizes patient comfort. The two methods of initial management for humeral shaft fractures are sarmiento bracing (pre-fabricated fracture brace) and coaptation splinting. In this study, the team will compare patient related outcomes and comfort for each method of initial management of humeral shaft fractures. Participant pain, narcotic usage, and function will be tracked over a 2 week period to see which method of immobilization is preferred.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Coaptation Splint | Active comparator | Procedure: Webril Padded Plaster Splint |
| Sarmiento Brace | Active comparator | Procedure: Pre-Fabricated Fracture Brace |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Presenting to an emergency room or ICARE in the participating centers with an acute humeral shaft fracture
- Age above 18 and skeletally mature
- Isolated Injury
- Treated non-operatively first 2 weeks
Key exclusion criteria (5 listed)
- Open fractures
- Poly trauma
- Injuries deemed operative by attending surgeon
- Patients undergoing treatment for malignancy
- Prisoners
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Webril Padded Plaster SplintPatients 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. | Procedure or surgery | Coaptation Splint |
| Pre-Fabricated Fracture BracePatients 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. | Procedure or surgery | Sarmiento Brace |
Primary outcome
Score on Pain Visual Analogue Scale (VAS)
Time frame: Week 1 post-treatment
The Visual Analog Scale (VAS) is a 10 cm line with anchor statements on the left (no pain) and on the right (extreme pain). The patient is asked to mark their current pain level on the line. The total range of score is 0 (no pain) to 10 (unbearable pain); the higher the pain, the greater the amount of pain.
Score on Pain Visual Analogue Scale (VAS)
Time frame: Week 2 post-treatment
The Visual Analog Scale (VAS) is a 10 cm line with anchor statements on the left (no pain) and on the right (extreme pain). The patient is asked to mark their current pain level on the line. The total range of score is 0 (no pain) to 10 (unbearable pain); the higher the pain, the greater the amount of pain.
Number of Tramadol Pills Taken
Time frame: Week 1 post-treatment
All patients will be discharged with 28 pills of tramadol 50mg. At week 1 follow-up, number of tramadol pills taken will be reported.
Number of Tramadol Pills Taken
Time frame: Week 2 post-treatment
All patients will be discharged with 28 pills of tramadol 50mg. At week 2 follow-up, number of tramadol pills taken will be reported.
3 secondary outcomes
Incidence of cutaneous complications
Time frame: Week 2 post-treatment
Score on PROMIS - Physical Function - Short Form 10b
Time frame: Week 1 post-treatment
Score on PROMIS - Physical Function - Short Form 10b
Time frame: Week 2 post-treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Derived from this study: PubMed 42466769Kingery MT, Ganta A, Egol KA. Comparison of Early Bracing Versus Splinting for the Initial Treatment of Acute Humeral Shaft Fractures (The COBRAS Trial). J Orthop Trauma. 2026 Aug 1;40(8):408-415. doi: 10.1097/BOT.0000000000003196.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be available upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Abhishek Ganta, MD principal investigator
NYU Langone Health
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Webril Padded Plaster Splint and Pre-Fabricated Fracture Brace in people with Humeral Fractures, run by NYU Langone Health at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Score on Pain Visual Analogue Scale (VAS) (time frame: Week 1 post-treatment). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05118087, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.