Acute Management of Humeral Shaft Fractures: Sling vs. Splint

NCT ID: NCT01869322

Last Updated: 2024-05-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-07-31
• Study Completion Date: 2022-05-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Sling and Swathe

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

Group Type: EXPERIMENTAL

Sling and Swathe

Intervention Type: DEVICE

Sling and Swathe immobilization of humeral shaft fracture.

Coaptation Splint

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

Group Type: ACTIVE_COMPARATOR

Coaptation Splint

Intervention Type: DEVICE

Coaptation splint immobilization of humeral shaft fractures.

Interventions

Sling and Swathe

Sling and Swathe immobilization of humeral shaft fracture.

Intervention Type: DEVICE

Coaptation Splint

Coaptation splint immobilization of humeral shaft fractures.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Oregon Health and Science University

OTHER

Sponsor Role: lead

Responsible Party

Darin Friess, M.D., M.P.H.

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Darin Friess, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Oregon Health and Science University

Locations

Oregon Health & Science University

Portland, Oregon, United States

Countries

United States

Other Identifiers

IRB00009456

Identifier Type: -

Identifier Source: org_study_id