Time to Diagnosis of Glenohumeral Joint Dislocations in the ED- Traditional Radiography vs. POC Ultrasound

August 16, 2023 updated by: University of Nebraska

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Adult patients (19 and older in state of Nebraska) who present to the emergency department with shoulder pain/injury and potential shoulder dislocation

Exclusion Criteria:

  • Injury sustained in major traumatic event (trauma activation), unable to consent, in extremis, less then 19 years of age

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ultrasound
After randomization, these subjects will undergo diagnostic point-of-care ultrasound
Procedure: Shoulder reduction
This is standard of care and only measure as a time component outcome in the study
Active Comparator: Radiograph
After randomization, these subjects will undergo diagnostic plain radiograph
Procedure: Shoulder reduction
This is standard of care and only measure as a time component outcome in the study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
0 to 60 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to reduction of dislocation joint
Time Frame: 1 to 6 hours
Time from presentation in Emergency Department to treatment (reduction of joint dislocation)
1 to 6 hours
Emergency Department Length of Stay
Time Frame: 1 to 12 hours
Total time in Emergency Department
1 to 12 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Nebraska

Investigators

  • Principal Investigator: Bradford C Huff, MD, University of Nebraska

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2022

Primary Completion (Actual)

July 5, 2022

Study Completion (Actual)

July 5, 2022

Study Registration Dates

First Submitted

January 17, 2022

First Submitted That Met QC Criteria

February 1, 2022

First Posted (Actual)

February 11, 2022

Study Record Updates

Last Update Posted (Actual)

August 21, 2023

Last Update Submitted That Met QC Criteria

August 16, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0790-21-FB

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is no currently plan to share IPD with other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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