Acute Management of Humeral Shaft Fractures: Sling vs. Splint

Fracture of Shaft of Humerus Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01869322
• Other study ID #: IRB00009456
• Status: Completed
• Phase: N/A
• Start date: July 2013
• Est. completion date: May 2022

Study information

• Verified date: May 2024
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: May 2022
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Fracture of Shaft of Humerus
• Fractures, Bone

Intervention

Device:
• Sling and Swathe
Sling and Swathe immobilization of humeral shaft fracture.
• Coaptation Splint
Coaptation splint immobilization of humeral shaft fractures.

Locations

Country	Name	City	State
United States	Oregon Health & Science University	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Oregon Health and Science University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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