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

• Sponsor: NYU Langone Health (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05118087
• Collaborator: (none)
• Enrollment: 66
• Locations: 3
• Arms: 2
• Anticipated Duration (Months): 47.5
• Patients Per Site: 22
• Patients Per Site Per Month: 0.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Humeral Fractures	Procedure: Webril Padded Plaster Splint; Procedure: Pre-Fabricated Fracture Brace	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 66 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Comparison of Bracing With Co-aptation Splinting for the Initial Treatment of Acute Humeral Shaft Fractures: The COBRAS Trials
• Actual Study Start Date: Jul 20, 2021
• Anticipated Primary Completion Date: Dec 31, 2024
• Anticipated Study Completion Date: Jul 6, 2025

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Coaptation Splint	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.
Active Comparator: Sarmiento Brace	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.

Outcome Measures

Primary Outcome Measures

1. Score on Pain Visual Analogue Scale (VAS) [Week 1 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.

2. 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.

3. Number of Tramadol Pills Taken [Week 1 post-treatment]

   All patients will be discharged with 28 pills of tramadol 50mg. At week 1 follow-up, number of tramadol pills taken will be reported.

4. 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

1. 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

2. Score on PROMIS - Physical Function - Short Form 10b [Week 1 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.

3. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	NYU Winthrop Hospital	Garden City	New York	United States	11530
2	NYU Langone Health	New York	New York	United States	10016
3	Jamaica Hospital Medical Center	Queens	New York	United States	11418

Sponsors and Collaborators

• NYU Langone Health

Investigators

• Principal Investigator: Abhishek Ganta, MD, NYU Langone Health

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: NYU Langone Health
• ClinicalTrials.gov Identifier: NCT05118087
• Other Study ID Numbers: 21-00438
• First Posted: Nov 11, 2021
• Last Update Posted: Aug 25, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by NYU Langone Health: Sarmiento Brace; Coaptation Splint
• Additional relevant MeSH terms: Fractures, Bone; Humeral Fractures

Study Results

No Results Posted as of Aug 25, 2022