Acute Management of Humeral Shaft Fractures: Sling vs. Splint

NCT01869322 | Completed

• 1 other identifier: IRB00009456
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Fracture of Shaft of Humerus

Keywords

Humerus; Fracture; Sling; Splint; Coaptation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Patient Pain

  5 days

Study Arms (2)

Sling and Swathe

EXPERIMENTAL

In this arm, study subjects will receive sling and swathe immobilization for humeral shaft fracture.

Device: Sling and Swathe

Coaptation Splint

ACTIVE COMPARATOR

In this arm participants receive a coaptation splint for humeral shaft fracture.

Device: Coaptation Splint

Interventions

Sling and Swathe DEVICE

Sling and Swathe immobilization of humeral shaft fracture.

Sling and Swathe

Coaptation Splint DEVICE

Coaptation splint immobilization of humeral shaft fractures.

Coaptation Splint

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Oregon Health and Science University: lead

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Fractures, Bone

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Darin Friess, MD, MPH

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 31, 2013
• First Posted: June 5, 2013
• Study Start: July 1, 2013
• Primary Completion: December 1, 2021
• Study Completion: May 1, 2022
• Last Updated: May 16, 2024

Record last verified: 2024-05

Locations

US (1)