NCT05118087

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
PROCEDURE	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.
PROCEDURE	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.

Timeline

• Start date: 2021-07-20
• Primary completion: 2025-10-01
• Completion: 2025-11-01
• First posted: 2021-11-11
• Last updated: 2026-02-27

Locations

3 sites across 1 country: United States