Comparison of Bracing With Co-aptation Splinting for the Initial Treatment of Acute Humeral Shaft Fractures: The COBRAS Trials

NCT05118087 | Completed

• 1 other identifier: 21-00438
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 3

Brief 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. 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

Keywords

Sarmiento Brace; Coaptation Splint

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  Week 2 post-treatment

Secondary Outcomes (3)

• Incidence of cutaneous complications

  Week 2 post-treatment

• Score on PROMIS - Physical Function - Short Form 10b

  Week 1 post-treatment

• Score on PROMIS - Physical Function - Short Form 10b

  Week 2 post-treatment

Study Arms (2)

Coaptation Splint

ACTIVE COMPARATOR

Procedure: Webril Padded Plaster Splint

Sarmiento Brace

ACTIVE COMPARATOR

Procedure: Pre-Fabricated Fracture Brace

Interventions

Webril Padded Plaster Splint PROCEDURE

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.

Coaptation Splint

Pre-Fabricated Fracture Brace PROCEDURE

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.

Sarmiento Brace

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Open fractures
• Poly trauma
• Injuries deemed operative by attending surgeon
• Patients undergoing treatment for malignancy
• Prisoners

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (3)

NYU Winthrop Hospital

Garden City, New York, 11530, United States

Location

NYU Langone Health

New York, New York, 10016, United States

Location

Jamaica Hospital Medical Center

Queens, New York, 11418, United States

Location

MeSH Terms

Conditions

Humeral Fractures

Condition Hierarchy (Ancestors)

Arm Injuries; Wounds and Injuries; Fractures, Bone

Study Officials

• Abhishek Ganta, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2021
• First Posted: November 11, 2021
• Study Start: July 20, 2021
• Primary Completion: October 1, 2025
• Study Completion: November 1, 2025
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Immediately following publication. No end date.
• Access Criteria: The investigator who proposed to use the data will have access to the data upon reasonable request. Requests should be directed to abhishek.ganta@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.

Locations

US (3)