Fracture of Shaft of HumerusNCT01869322
Acute Management of Humeral Shaft Fractures: Sling vs. Splint
A study testing Sling and Swathe and Coaptation Splint in people with Fracture of Shaft of Humerus, run by Oregon Health and Science University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Fracture of Shaft of Humerus
- What is being tested?
- Sling and Swathe and Coaptation Splint
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2013to May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 18-80
- acute midshaft humeral fracture within 48 hours
Who cannot join
- ED presentation more than 48 hours after injury
- Head injury
- Open fracture
- Pathological fracture
- Known pregnancy
- Inmate or prisoner
Show all 9Show fewer
- Non-English speaking
- Sexual Assault (SA) victim
- Patient and Legally Authorized Representative unable to provide consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health & Science University
Portland, Oregon, 97239
About this study
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
- Being tested
- Sling and Swathe, Coaptation Splint
- Keywords
- Humerus, Fracture, Sling, Splint, Coaptation
- Medical subject headings
- Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sling and SwatheDevice
Sling and Swathe immobilization of humeral shaft fracture.
Coaptation SplintDevice
Coaptation splint immobilization of humeral shaft fractures.
| Study group | Role | What they receive |
|---|---|---|
| Sling and Swathe | Experimental | In this arm, study subjects will receive sling and swathe immobilization for humeral shaft fracture. Receives: Device: Sling and Swathe |
| Coaptation Splint | Active comparator | In this arm participants receive a coaptation splint for humeral shaft fracture. Receives: Device: Coaptation Splint |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 days
Secondary outcomes (1)
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
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2013 (estimated)
- Study startJul 2013
- Primary completionDec 2021
- Study completionMay 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fracture of Shaft of HumerusStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Darin Friess, M.D., M.P.H., Oregon Health and Science University
- Investigators
- Darin Friess, MD, MPH, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01869322
- Sponsor's protocol ID
- IRB00009456
- Status last verified
- May 2024
- First submitted
- 31 May 2013
- Last updated
- 16 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Management of Humeral Shaft Fractures: Sling vs. Splint
- ClinicalTrials.gov ID
- NCT01869322
- Acronym / sponsor ID
- IRB00009456
- Conditions
- Fracture of Shaft of Humerus
- Keywords
- Humerus, Fracture, Sling, Splint, Coaptation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- Jul 2013 (actual)
- Primary completion
- Dec 2021 (actual)
- Study completion
- May 2022 (actual)
- First posted
- 5 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sling and Swathe | Experimental | Device: Sling and SwatheIn this arm, study subjects will receive sling and swathe immobilization for humeral shaft fracture. |
| Coaptation Splint | Active comparator | Device: Coaptation SplintIn this arm participants receive a coaptation splint for humeral shaft fracture. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- age 18-80
- acute midshaft humeral fracture within 48 hours
Key exclusion criteria (9 listed)
- ED presentation more than 48 hours after injury
- Head injury
- Open fracture
- Pathological fracture
- Known pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sling and SwatheSling and Swathe immobilization of humeral shaft fracture. | Device | Sling and Swathe |
| Coaptation SplintCoaptation splint immobilization of humeral shaft fractures. | Device | Coaptation Splint |
Primary outcome
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.
1 secondary outcome
Patient Pain
Time frame: 5 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Darin Friess, MD, MPH principal investigator
Oregon Health and Science University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sling and Swathe and Coaptation Splint in people with Fracture of Shaft of Humerus, run by Oregon Health and Science University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Satisfaction (time frame: 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2024.