Glenohumeral DislocationNCT05237167
Time to Diagnosis of Glenohumeral Joint Dislocations in the ED- Traditional Radiography vs. POC Ultrasound
A study testing Shoulder reduction in people with Glenohumeral Dislocation, run by University of Nebraska.
Trial summary
This is study to compare the time to diagnosis of glenohumeral joint dislocation using two imaging methods, traditional x-ray and point-of-care ultrasound. Participants who present at the emergency department complaining of shoulder injury and who are suspected of having a possible glenohumeral shoulder dislocation… Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Glenohumeral Dislocation
- What is being tested?
- Shoulder reduction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 5 Jul 2022to 5 Jul 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 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult patients (19 and older in state of Nebraska) who present to the emergency department with shoulder pain/injury and potential shoulder dislocation
Who cannot join
- Injury sustained in major traumatic event (trauma activation), unable to consent, in extremis, less then 19 years of age
About this study
Official title: Time to Diagnosis of Glenohumeral Joint Dislocations in the Emergency Department- Traditional Radiography Versus Point-of-care Ultrasound
This is study to compare the time to diagnosis of glenohumeral joint dislocation using two imaging methods, traditional x-ray and point-of-care ultrasound. Participants who present at the emergency department complaining of shoulder injury and who are suspected of having a possible glenohumeral shoulder dislocation will be eligible for the study. A reduction of the joint will be performed if imaging findings so indicate. All participants will receive a post-reduction x-ray and be referred to appropriate follow-up care.
Read the detailed description
This is a prospective comparison study evaluating the time to diagnosis of glenohumeral joint dislocation using two imaging modalities, traditional x-ray and point-of-care ultrasound. Eligible participants will include those who present to the emergency department with complaints of shoulder injury who are suspected by triage nursing of having a possible glenohumeral shoulder dislocation. Eligible participants will be consented by participating physicians and randomized into ultrasound or x-ray groups. If indicated based on the imaging findings, a reduction of the joint will be performed. All patients will receive a post-reduction x-ray and be referred to appropriate follow-up care based on the findings of their evaluation.
- Conditions
- Glenohumeral Dislocation
- Being tested
- Shoulder reduction
- Keywords
- glenohumeral dislocation, POC Ultrasound, Plain radiograph
- Medical subject headings
- Shoulder Dislocation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shoulder reductionProcedure or surgery
This is standard of care and only measure as a time component outcome in the study
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound | Experimental | After randomization, these subjects will undergo diagnostic point-of-care ultrasound Receives: Procedure: Shoulder reduction |
| Radiograph | Active comparator | After randomization, these subjects will undergo diagnostic plain radiograph Receives: Procedure: Shoulder reduction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to diagnosis of glenohumeral joint dislocations
Comparison between point-of-care ultrasound and plain radiograph in time to diagnosis of glenohumeral joint dislocations who present to the emergency department
Measured: 0 to 60 minutes
Secondary outcomes (2)
Time to reduction of dislocation joint
Time from presentation in Emergency Department to treatment (reduction of joint dislocation)
Measured: 1 to 6 hours
Emergency Department Length of Stay
Total time in Emergency Department
Measured: 1 to 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2022
- Study start5 Jul 2022
- Primary completion5 Jul 2022
- Study completion5 Jul 2022
Why it stopped: The study was ultimately found to be too difficult to enroll patients and have an adequate control.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Glenohumeral DislocationStudies of the same condition, open and under way.
- More trials run by University of NebraskaThe 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective randomized diagnostic comparison study
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bradford C Huff, MD, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05237167
- Sponsor's protocol ID
- 0790-21-FB
- Status last verified
- Aug 2024
- First submitted
- 17 Jan 2022
- Last updated
- 3 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no currently plan to share IPD with other researchers.
Publications
Secko MA, Reardon L, Gottlieb M, Morley EJ, Lohse MR, Thode HC Jr, Singer AJ. Musculoskeletal Ultrasonography to Diagnose Dislocated Shoulders: A Prospective Cohort. Ann Emerg Med. 2020 Aug;76(2):119-128. doi: 10.1016/j.annemergmed.2020.01.008. Epub 2020 Feb 25.
PubMed 32111508Kanji A, Atkinson P, Fraser J, Lewis D, Benjamin S. Delays to initial reduction attempt are associated with higher failure rates in anterior shoulder dislocation: a retrospective analysis of factors affecting reduction failure. Emerg Med J. 2016 Feb;33(2):130-3. doi: 10.1136/emermed-2015-204746. Epub 2015 Jun 25.
PubMed 26113487Gottlieb M, Russell F. Diagnostic Accuracy of Ultrasound for Identifying Shoulder Dislocations and Reductions: A Systematic Review of the Literature. West J Emerg Med. 2017 Aug;18(5):937-942. doi: 10.5811/westjem.2017.5.34432. Epub 2017 Jul 10.
PubMed 28874947Abbasi S, Molaie H, Hafezimoghadam P, Zare MA, Abbasi M, Rezai M, Farsi D. Diagnostic accuracy of ultrasonographic examination in the management of shoulder dislocation in the emergency department. Ann Emerg Med. 2013 Aug;62(2):170-5. doi: 10.1016/j.annemergmed.2013.01.022. Epub 2013 Mar 13.
PubMed 23489654Lahham S, Becker B, Chiem A, Joseph LM, Anderson CL, Wilson SP, Subeh M, Trinh A, Viquez E, Fox JC. Pilot Study to Determine Accuracy of Posterior Approach Ultrasound for Shoulder Dislocation by Novice Sonographers. West J Emerg Med. 2016 May;17(3):377-82. doi: 10.5811/westjem.2016.2.29290. Epub 2016 Apr 26.
PubMed 27330675Akyol C, Gungor F, Akyol AJ, Kesapli M, Guven R, Cengiz U, Toksul HI, Eken C. Point-of-care ultrasonography for the management of shoulder dislocation in ED. Am J Emerg Med. 2016 May;34(5):866-70. doi: 10.1016/j.ajem.2016.02.006. Epub 2016 Feb 16.
PubMed 26935225
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Time to Diagnosis of Glenohumeral Joint Dislocations in the Emergency Department- Traditional Radiography Versus Point-of-care Ultrasound
- ClinicalTrials.gov ID
- NCT05237167
- Acronym / sponsor ID
- 0790-21-FB
- Conditions
- Glenohumeral Dislocation
- Keywords
- glenohumeral dislocation, POC Ultrasound, Plain radiograph
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study was ultimately found to be too difficult to enroll patients and have an adequate control.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Study start
- 5 Jul 2022 (actual)
- Primary completion
- 5 Jul 2022 (actual)
- Study completion
- 5 Jul 2022 (actual)
- First posted
- 11 Feb 2022 (actual)
- 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.
This is study to compare the time to diagnosis of glenohumeral joint dislocation using two imaging methods, traditional x-ray and point-of-care ultrasound. Participants who present at the emergency department complaining of shoulder injury and who are suspected of having a possible glenohumeral shoulder dislocation will be eligible for the study. A reduction of the joint will be performed if imaging findings so indicate. All participants will receive a post-reduction x-ray and be referred to appropriate follow-up care.
Detailed description
This is a prospective comparison study evaluating the time to diagnosis of glenohumeral joint dislocation using two imaging modalities, traditional x-ray and point-of-care ultrasound. Eligible participants will include those who present to the emergency department with complaints of shoulder injury who are suspected by triage nursing of having a possible glenohumeral shoulder dislocation. Eligible participants will be consented by participating physicians and randomized into ultrasound or x-ray groups. If indicated based on the imaging findings, a reduction of the joint will be performed. All patients will receive a post-reduction x-ray and be referred to appropriate follow-up care based on the findings of their evaluation.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective randomized diagnostic comparison study
| Arm | Type | Receives |
|---|---|---|
| Ultrasound | Experimental | Procedure: Shoulder reductionAfter randomization, these subjects will undergo diagnostic point-of-care ultrasound |
| Radiograph | Active comparator | Procedure: Shoulder reductionAfter randomization, these subjects will undergo diagnostic plain radiograph |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients (19 and older in state of Nebraska) who present to the emergency department with shoulder pain/injury and potential shoulder dislocation
Key exclusion criteria (1 listed)
- Injury sustained in major traumatic event (trauma activation), unable to consent, in extremis, less then 19 years of age
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 |
|---|---|---|
| Shoulder reductionThis is standard of care and only measure as a time component outcome in the study | Procedure or surgery | Radiograph, Ultrasound |
Primary outcome
Time to diagnosis of glenohumeral joint dislocations
Time frame: 0 to 60 minutes
Comparison between point-of-care ultrasound and plain radiograph in time to diagnosis of glenohumeral joint dislocations who present to the emergency department
2 secondary outcomes
Time to reduction of dislocation joint
Time frame: 1 to 6 hours
Emergency Department Length of Stay
Time frame: 1 to 12 hours
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2024.
- Background: PubMed 32111508Secko MA, Reardon L, Gottlieb M, Morley EJ, Lohse MR, Thode HC Jr, Singer AJ. Musculoskeletal Ultrasonography to Diagnose Dislocated Shoulders: A Prospective Cohort. Ann Emerg Med. 2020 Aug;76(2):119-128. doi: 10.1016/j.annemergmed.2020.01.008. Epub 2020 Feb 25.
- Background: PubMed 26113487Kanji A, Atkinson P, Fraser J, Lewis D, Benjamin S. Delays to initial reduction attempt are associated with higher failure rates in anterior shoulder dislocation: a retrospective analysis of factors affecting reduction failure. Emerg Med J. 2016 Feb;33(2):130-3. doi: 10.1136/emermed-2015-204746. Epub 2015 Jun 25.
- Background: PubMed 28874947Gottlieb M, Russell F. Diagnostic Accuracy of Ultrasound for Identifying Shoulder Dislocations and Reductions: A Systematic Review of the Literature. West J Emerg Med. 2017 Aug;18(5):937-942. doi: 10.5811/westjem.2017.5.34432. Epub 2017 Jul 10.
- Background: PubMed 23489654Abbasi S, Molaie H, Hafezimoghadam P, Zare MA, Abbasi M, Rezai M, Farsi D. Diagnostic accuracy of ultrasonographic examination in the management of shoulder dislocation in the emergency department. Ann Emerg Med. 2013 Aug;62(2):170-5. doi: 10.1016/j.annemergmed.2013.01.022. Epub 2013 Mar 13.
- Background: PubMed 27330675Lahham S, Becker B, Chiem A, Joseph LM, Anderson CL, Wilson SP, Subeh M, Trinh A, Viquez E, Fox JC. Pilot Study to Determine Accuracy of Posterior Approach Ultrasound for Shoulder Dislocation by Novice Sonographers. West J Emerg Med. 2016 May;17(3):377-82. doi: 10.5811/westjem.2016.2.29290. Epub 2016 Apr 26.
- Background: PubMed 26935225Akyol C, Gungor F, Akyol AJ, Kesapli M, Guven R, Cengiz U, Toksul HI, Eken C. Point-of-care ultrasonography for the management of shoulder dislocation in ED. Am J Emerg Med. 2016 May;34(5):866-70. doi: 10.1016/j.ajem.2016.02.006. Epub 2016 Feb 16.
- Individual participant dataSharing planned: No. There is no currently plan to share IPD with other researchers.
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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.
Bradford C Huff, MD principal investigator
University of Nebraska
Questions about this trial
What is this clinical trial studying?
A study testing Shoulder reduction in people with Glenohumeral Dislocation, run by University of Nebraska.
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 1 inclusion and 1 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: withdrawn, as of the sponsor's last update on 3 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Time to diagnosis of glenohumeral joint dislocations (time frame: 0 to 60 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05237167, which also lists 6 linked publications.
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 3 Sep 2024.