Shoulder DislocationEASiURNCT04820491
Efficient Anterior Shoulder Ultrasound Reduction Multicenter Prospective Randomized Trial
A study testing X-Ray and Ultrasound in people with Shoulder Dislocation, run by Virginia Commonwealth University at 1 site in United States.
Trial summary
The purpose of the study is to determine if using ultrasound to diagnosis and confirm reductions of shoulder dislocations impacts the length of an emergency department visit for this condition. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Shoulder Dislocation
- What is being tested?
- X-Ray and Ultrasound
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Mar 2021to 21 Oct 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who are 18 years of age or older; and
- Present to the VCU Emergency Department; and
- Have clinical signs of uncomplicated shoulder dislocation; and
- Agree to participation in the study; and
- Provides a written consent to be included in the study.
Who cannot join
- Patients who have a level 1 or 2 trauma activation, and/or;
- Patients who are pregnant, incarcerated, or unable to consent, and/or;
- Patients who have a past medical history of shoulder replacement in dislocated shoulder; and/or
- Provider Discretion
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University
Richmond, Virginia, 23298
About this study
Official title: EASiUR Trial: Efficient Anterior Shoulder Ultrasound Reduction Multicenter Prospective Randomized Trial
The purpose of the study is to determine if using ultrasound to diagnosis and confirm reductions of shoulder dislocations impacts the length of an emergency department visit for this condition.
Read the detailed description
The purpose of the study is to determine if the length of the emergency department visit can be decreased and if patient exposure to x-rays can be reduced by utilizing an ultrasound to diagnose and confirm reduction in shoulder dislocations.
This study also seeks to determine if patients prefer ultrasound to x-ray when used to treat their shoulder dislocation.
Participants will be randomly assigned to one of two groups: either x-rays or ultrasound for the diagnosis and reduction confirmation of your shoulder dislocation.
Participant's shoulder dislocation will be treated per standard of care.
Participants will be asked to complete a short survey at the end of their visit.
- Conditions
- Shoulder Dislocation
- Being tested
- X-Ray, Ultrasound
- Medical subject headings
- Shoulder Dislocation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
X-RayDiagnostic test
Shoulder x-rays as felt necessary for standard of care of diagnosis of shoulder dislocation and reduction
UltrasoundDiagnostic test
Initial evaluation with ultrasound; may also evaluate nearby areas for concern of fracture. Order x- rays after ultrasound as seen fit for other injuries of diagnostic uncertainty.
| Study group | Role | What they receive |
|---|---|---|
| X-Ray | Active comparator | Not described Receives: Diagnostic Test: X-Ray |
| Ultrasound | Active comparator | Not described Receives: Diagnostic Test: Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of Stay in the Emergency Department (ED)
Length of stay in the ED will be calculated from time of first provider contact to time of discharge from the ED.
Measured: up to 8 hours or time to admission
Secondary outcomes (5)
Patient Satisfaction
Patient satisfaction will be assessed using a 6 item scale. Each item is rated from 1 (extremely dissatisfied) to 5 (extremely satisfied). Scores are summed yielding scores ranging from 6 (most dissatisfied) to 30 (most satisfied).
Measured: at discharge or admission - up to 8 hours
Time to Diagnosis
Time to diagnosis will be calculated from time of first provider contact to time of x-ray or time of ultrasound per treatment condition
Measured: up to 8 hours or time to admission
Confirmation of Reduction
As documented by x-ray or ultrasound per treatment condition
Measured: up to 8 hours or time to admission
Cost of Treatment
Calculated as total billing cost of procedures related to shoulder dislocation ED visit
Measured: up to 8 hours or time to admission
Total Number of Xrays
Total number of xrays ordered during time in ED
Measured: up to 8 hours or time to admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2021
- Study start26 Mar 2021
- Primary completion21 Oct 2021
- Study completion21 Oct 2021
Why it stopped: Lack of enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Shoulder DislocationStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jordan Tozer, MD, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04820491
- Sponsor's protocol ID
- HM20019991
- Acronym
- EASiUR
- Status last verified
- Oct 2022
- First submitted
- 25 Mar 2021
- Last updated
- 16 Nov 2022
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EASiUR Trial: Efficient Anterior Shoulder Ultrasound Reduction Multicenter Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT04820491
- Acronym / sponsor ID
- EASiUR / HM20019991
- Conditions
- Shoulder Dislocation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of enrollment
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Study start
- 26 Mar 2021 (actual)
- Primary completion
- 21 Oct 2021 (actual)
- Study completion
- 21 Oct 2021 (actual)
- First posted
- 29 Mar 2021 (actual)
- Results
- Posted 16 Nov 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to determine if using ultrasound to diagnosis and confirm reductions of shoulder dislocations impacts the length of an emergency department visit for this condition.
Detailed description
The purpose of the study is to determine if the length of the emergency department visit can be decreased and if patient exposure to x-rays can be reduced by utilizing an ultrasound to diagnose and confirm reduction in shoulder dislocations.
This study also seeks to determine if patients prefer ultrasound to x-ray when used to treat their shoulder dislocation.
Participants will be randomly assigned to one of two groups: either x-rays or ultrasound for the diagnosis and reduction confirmation of your shoulder dislocation.
Participant's shoulder dislocation will be treated per standard of care.
Participants will be asked to complete a short survey at the end of their visit.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| X-Ray | Active comparator | Diagnostic Test: X-Ray |
| Ultrasound | Active comparator | Diagnostic Test: Ultrasound |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients who are 18 years of age or older; and
- Present to the VCU Emergency Department; and
- Have clinical signs of uncomplicated shoulder dislocation; and
- Agree to participation in the study; and
- Provides a written consent to be included in the study.
Key exclusion criteria (4 listed)
- Patients who have a level 1 or 2 trauma activation, and/or;
- Patients who are pregnant, incarcerated, or unable to consent, and/or;
- Patients who have a past medical history of shoulder replacement in dislocated shoulder; and/or
- Provider Discretion
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 |
|---|---|---|
| X-RayShoulder x-rays as felt necessary for standard of care of diagnosis of shoulder dislocation and reduction | Diagnostic test | X-Ray |
| UltrasoundInitial evaluation with ultrasound; may also evaluate nearby areas for concern of fracture. Order x- rays after ultrasound as seen fit for other injuries of diagnostic uncertainty. | Diagnostic test | Ultrasound |
Primary outcome
Length of Stay in the Emergency Department (ED)
Time frame: up to 8 hours or time to admission
Length of stay in the ED will be calculated from time of first provider contact to time of discharge from the ED.
5 secondary outcomes
Patient Satisfaction
Time frame: at discharge or admission - up to 8 hours
Time to Diagnosis
Time frame: up to 8 hours or time to admission
Confirmation of Reduction
Time frame: up to 8 hours or time to admission
Cost of Treatment
Time frame: up to 8 hours or time to admission
Total Number of Xrays
Time frame: up to 8 hours or time to admission
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Jordan Tozer, MD principal investigator
Virginia Commonwealth 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 X-Ray and Ultrasound in people with Shoulder Dislocation, run by Virginia Commonwealth 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 5 inclusion and 4 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: stopped early, as of the sponsor's last update on 16 Nov 2022. 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?
Yes. Results are posted in the registry (first posted 16 Nov 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Length of Stay in the Emergency Department (ED) (time frame: up to 8 hours or time to admission). 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 Nov 2022.