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

Study Overview
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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.

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

Conditions
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Humeral Fractures

Intervention / Treatment
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* Procedure: Webril Padded Plaster Splint
* Procedure: Pre-Fabricated Fracture Brace


Participation Criteria
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Eligibility Criteria
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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 Prisoners

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Coaptation Splint<br> | Procedure: Webril Padded Plaster Splint<br>* 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.<br>|
| Active Comparator: Sarmiento Brace<br> | Procedure: Pre-Fabricated Fracture Brace<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sarmiento Brace, Coaptation Splint