Efficient Anterior Shoulder Ultrasound Reduction Multicenter Prospective Randomized Trial

NCT04820491 | Terminated Results FDA Device

• 1 other identifier: HM20019991
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Shoulder Dislocation

Outcome Measures

Primary Outcomes (1)

• 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.

  up to 8 hours or time to admission

Secondary Outcomes (5)

• Patient Satisfaction

  at discharge or admission - up to 8 hours

• Time to Diagnosis

  up to 8 hours or time to admission

• Confirmation of Reduction

  up to 8 hours or time to admission

• Cost of Treatment

  up to 8 hours or time to admission

• Total Number of Xrays

  up to 8 hours or time to admission

Study Arms (2)

X-Ray

ACTIVE COMPARATOR

Diagnostic Test: X-Ray

Ultrasound

ACTIVE COMPARATOR

Diagnostic Test: Ultrasound

Interventions

X-Ray DIAGNOSTIC_TEST

Shoulder x-rays as felt necessary for standard of care of diagnosis of shoulder dislocation and reduction

X-Ray

Ultrasound DIAGNOSTIC_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.

Ultrasound

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Virginia Commonwealth University: lead

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

Shoulder Dislocation

Interventions

X-Rays; Ultrasonography

Condition Hierarchy (Ancestors)

Joint Dislocations; Joint Diseases; Musculoskeletal Diseases; Wounds and Injuries; Shoulder Injuries

Intervention Hierarchy (Ancestors)

Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Radiation; Radiation, Ionizing; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Results Point of Contact

• Title: Jordan Tozer
• Organization: Virginia Commonwealth University

jordan.tozer@vcuhealth.org

804-828-5250

Study Officials

• Jordan Tozer, MD

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2021
• First Posted: March 29, 2021
• Study Start: March 26, 2021
• Primary Completion: October 21, 2021
• Study Completion: October 21, 2021
• Last Updated: November 16, 2022
• Results First Posted: November 16, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)