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

Humeral Fractures Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05118087
• Other study ID #: 21-00438
• Status: Recruiting
• Phase: N/A
• Start date: July 20, 2021
• Est. completion date: July 6, 2025

Study information

• Verified date: June 2024
• Source: NYU Langone Health
• Contact: Abhishek Ganta, MD
• Phone: 718-206-6923
• Email: abhishek.ganta[@]nyulangone.org
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 66
• Est. completion date: July 6, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fractures, Bone
• Humeral Fractures

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	NYU Winthrop Hospital	Garden City	New York
United States	NYU Langone Health	New York	New York
United States	Jamaica Hospital Medical Center	Queens	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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	Week 2 post-treatment
Secondary	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.	Week 1 post-treatment
Secondary	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.	Week 2 post-treatment