Acute Management of Humeral Shaft Fractures: Sling vs. Splint
Primary Purpose
Fracture of Shaft of Humerus
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sling and Swathe
Coaptation Splint
Sponsored by
About this trial
This is an interventional treatment trial for Fracture of Shaft of Humerus focused on measuring Humerus, Fracture, Sling, Splint, Coaptation
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
Sites / Locations
- Oregon Health and Science UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Sling and Swathe
Coaptation Splint
Arm Description
In this arm, study subjects will receive sling and swathe immobilization for humeral shaft fracture.
In this arm participants receive a coaptation splint for humeral shaft fracture.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
Full Information
NCT ID
NCT01869322
First Posted
May 31, 2013
Last Updated
January 18, 2019
Sponsor
Oregon Health and Science University
1. Study Identification
Unique Protocol Identification Number
NCT01869322
Brief Title
Acute Management of Humeral Shaft Fractures: Sling vs. Splint
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Unknown status
Study Start Date
May 2013 (undefined)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
May 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oregon Health and Science University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fracture of Shaft of Humerus
Keywords
Humerus, Fracture, Sling, Splint, Coaptation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Sling and Swathe
Arm Type
Experimental
Arm Description
In this arm, study subjects will receive sling and swathe immobilization for humeral shaft fracture.
Arm Title
Coaptation Splint
Arm Type
Active Comparator
Arm Description
In this arm participants receive a coaptation splint for humeral shaft fracture.
Intervention Type
Device
Intervention Name(s)
Sling and Swathe
Intervention Description
Sling and Swathe immobilization of humeral shaft fracture.
Intervention Type
Device
Intervention Name(s)
Coaptation Splint
Intervention Description
Coaptation splint immobilization of humeral shaft fractures.
Primary Outcome Measure Information:
Title
Patient Satisfaction
Description
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.
Time Frame
5 days
Secondary Outcome Measure Information:
Title
Patient Pain
Description
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
Time Frame
5 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
David Jenkins, BA
Phone
5034946376
Email
jenkidav@ohsu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Darin Friess, MD, MPH
Phone
5034946400
Email
friessd@ohsu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Darin Friess, MD, MPH
Organizational Affiliation
Oregon Health and Science University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oregon Health and Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Jenkins, BA
Phone
503-494-6376
Email
jenkidav@ohsu.edu
12. IPD Sharing Statement
Learn more about this trial
Acute Management of Humeral Shaft Fractures: Sling vs. Splint
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