Comparison of Bracing With Co-aptation Splinting for the Initial Treatment of Acute Humeral Shaft Fractures: The COBRAS Trials
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- NYU Langone Health
- Enrollment
- 80
- Locations
- 3
- Primary Endpoint
- Score on Pain Visual Analogue Scale (VAS)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Presenting to an emergency room or ICARE in the participating centers with an acute humeral shaft fracture
- •Age above 18 and skeletally mature
- •Isolated Injury
- •Treated non-operatively first 2 weeks
Exclusion Criteria
- •Open fractures
- •Poly trauma
- •Injuries deemed operative by attending surgeon
- •Patients undergoing treatment for malignancy
Arms & Interventions
Coaptation Splint
Intervention: Webril Padded Plaster Splint (Procedure)
Sarmiento Brace
Intervention: Pre-Fabricated Fracture Brace (Procedure)
Outcomes
Primary Outcomes
Score on Pain Visual Analogue Scale (VAS)
Time Frame: 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
Time Frame: 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.
Score on Pain Visual Analogue Scale (VAS)
Time Frame: 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.
Number of Tramadol Pills Taken
Time Frame: 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.
Secondary Outcomes
- Incidence of cutaneous complications(Week 2 post-treatment)
- Score on PROMIS - Physical Function - Short Form 10b(Week 2 post-treatment)
- Score on PROMIS - Physical Function - Short Form 10b(Week 1 post-treatment)