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

NCT ID: NCT05118087

Last Updated: 2025-04-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-20

Study Completion Date

2027-07-01

Brief Summary

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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

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Conditions

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Humeral Fractures

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Coaptation Splint

Group Type ACTIVE_COMPARATOR

Webril Padded Plaster Splint

Intervention Type 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.

Sarmiento Brace

Group Type ACTIVE_COMPARATOR

Pre-Fabricated Fracture Brace

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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NYU Langone Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Abhishek Ganta, MD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

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NYU Winthrop Hospital

Garden City, New York, United States

Site Status NOT_YET_RECRUITING

NYU Langone Health

New York, New York, United States

Site Status RECRUITING

Jamaica Hospital Medical Center

Queens, New York, United States

Site Status NOT_YET_RECRUITING

Countries

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United States

Central Contacts

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Abhishek Ganta, MD

Role: CONTACT

718-206-6923

Facility Contacts

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Meelan Patel, MD

Role: primary

Abhishek Ganta

Role: primary

Sanjit Konda, MD

Role: primary

Other Identifiers

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21-00438

Identifier Type: -

Identifier Source: org_study_id

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