Acute Management of Humeral Shaft Fractures: Sling vs. Splint

Not Applicable

Completed

• Conditions: Fracture of Shaft of Humerus
• Interventions: Device: Coaptation Splint; Device: Sling and Swathe

• Registration Number: NCT01869322
• Lead Sponsor: Oregon Health and Science University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-05-31
• Study First Submitted QC: 2013-06-04
• Study First Posted: 2013-06-05
• Study Start: 2013-07
• Primary Completion: 2021-12
• Study Completion: 2022-05
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-13
• Last Update Posted: 2024-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• age 18-80
• acute midshaft humeral fracture within 48 hours

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Coaptation Splint	Coaptation Splint	In this arm participants receive a coaptation splint for humeral shaft fracture.
Sling and Swathe	Sling and Swathe	In this arm, study subjects will receive sling and swathe immobilization for humeral shaft fracture.

Primary Outcome Measures

Name	Time	Method
Patient Satisfaction	5 days	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.

Secondary Outcome Measures

Name	Time	Method
Patient Pain	5 days	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

Trial Locations

Locations (1)

Oregon Health & Science University; 🇺🇸 Portland, Oregon, United States