Acute Management of Humeral Shaft Fractures: Sling vs. Splint

Study Overview
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Brief Summary
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When people break their arm and arrive at Oregon Health and Science University's Emergency Department (OHSU ED), they are treated with a short-term means of immobilizing their broken arm. The two most common ways of stabilizing the broken parts of the arm are 1) with a plaster-based coaptation splint, or 2) with a soft cloth sling and swathe. These hold the arm steady until the patient can schedule an appointment with the OHSU Orthopaedic Trauma clinic where they will receive definitive evaluation and stabilization/fixation. In much of the orthopaedic literature coaptation splints are the default immobilization method. The investigators hypothesize however, that sling and swathe immobilization may be equally effective for short term stabilization, while being faster to apply, and more comfortable for the patient. This randomized, unblinded prospective study will follow the satisfaction, quality of life and limited functional outcomes of all enrolled participants during the first week following their injury.

Conditions
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Fracture of Shaft of Humerus

Intervention / Treatment
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* Device: Sling and Swathe
* Device: Coaptation Splint


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age 18-80 acute midshaft humeral fracture within 48 hours Exclusion Criteria: ED presentation more than 48 hours after injury Head injury Open fracture Pathological fracture Known pregnancy Inmate or prisoner Non-English speaking Sexual Assault (SA) victim Patient and Legally Authorized Representative unable to provide consent

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- |
| Experimental: Sling and Swathe<br>In this arm, study subjects will receive sling and swathe immobilization for humeral shaft fracture. | Device: Sling and Swathe<br>* Sling and Swathe immobilization of humeral shaft fracture.<br>|
| Active Comparator: Coaptation Splint<br>In this arm participants receive a coaptation splint for humeral shaft fracture. | Device: Coaptation Splint<br>* Coaptation splint immobilization of humeral shaft fractures.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Satisfaction | Satisfaction questionaires will be administered 5 days after admission/enrollment in the study, or before any surgical fixation which occurs more than 48 hours after admission. | 5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Pain | Patient narcotic usage and NRS pain score will be collected 5 days from admission/enrollment, or before any surgical fixation which occurs more than 48 hours after admission | 5 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Humerus, Fracture, Sling, Splint, Coaptation