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OpenTrials
Completed

NCT Number: NCT01869322

Acute Management of Humeral Shaft Fractures: Sling vs. Splint

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sling and Swathe

Device

Sling and Swathe immobilization of humeral shaft fracture.

Coaptation Splint

Device

Coaptation splint immobilization of humeral shaft fractures.

Primary outcomes

  1. Patient Satisfaction

    Time frame: 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 outcomes

  1. Patient Pain

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Oregon Health and Science University

Other

Registry information

Important dates

Study start
2013
Primary completion
2021
Study completion
2022
First posted
Jun 5, 2013
Registry last updated
May 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.