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

Not Applicable

Recruiting

• Conditions: Humeral Fractures
• Interventions: Procedure: Pre-Fabricated Fracture Brace; Procedure: Webril Padded Plaster Splint

• Registration Number: NCT05118087
• Lead Sponsor: NYU Langone Health

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-07-20
• Study First Submitted: 2021-11-01
• Study First Submitted QC: 2021-11-01
• Study First Posted: 2021-11-11
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-14
• Last Update Posted: 2025-04-15
• Primary Completion: 2026-12-31
• Study Completion: 2027-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 66

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sarmiento Brace	Pre-Fabricated Fracture Brace	-
Coaptation Splint	Webril Padded Plaster Splint	-

Primary Outcome Measures

Name	Time	Method
Score on Pain Visual Analogue Scale (VAS)	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	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.

Secondary Outcome Measures

Name	Time	Method
Incidence of cutaneous complications	Week 2 post-treatment	Cutaneous complications between immediate fracture bracing and coaptation splints in the ER within the first 2 weeks of treatment will be reported
Score on PROMIS - Physical Function - Short Form 10b	Week 2 post-treatment	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.

Trial Locations

Locations (3)

Jamaica Hospital Medical Center; 🇺🇸 Queens, New York, United States

NYU Langone Health; 🇺🇸 New York, New York, United States

NYU Winthrop Hospital; 🇺🇸 Garden City, New York, United States