Musculoskeletal Ultrasound for Diagnosis of Shoulder Dislocation Reduction

Sponsor

Rutgers, The State University of New Jersey (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04703517

Collaborator

(none)

100

Enrollment

Arm

11.9

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

This study will compare the current standard of care post reduction plain film x ray for confirmation of shoulder reduction to point of care ultrasound. Patients will receive both the current standard of care post reduction x ray and point of care ultrasound to act as their own comparators

Condition or Disease	Intervention/Treatment	Phase
Ultrasound Shoulder Dislocation Musculoskeletal Injury	Diagnostic Test: Point of care ultrasound	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Musculoskeletal Ultrasonography to Diagnose Successful Reduction of Shoulder Dislocation

Anticipated Study Start Date :

Jan 1, 2021

Anticipated Primary Completion Date :

Dec 30, 2021

Anticipated Study Completion Date :

Dec 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
Other: Self Controlled Patients will active as their own comparator	Diagnostic Test: Point of care ultrasound Patients will receive a point of care ultrasound at the bedside in the Emergency Department and compare the impression to the x ray result

Arm

Intervention/Treatment

Other: Self Controlled

Patients will active as their own comparator

Diagnostic Test: Point of care ultrasound

Patients will receive a point of care ultrasound at the bedside in the Emergency Department and compare the impression to the x ray result

Outcome Measures

Primary Outcome Measures

Comparison of X ray to Ultrasound for Shoulder Reduction [through study completion up to 1 year]
Compare the impression of the x ray to the ultrasound for successful shoulder reduction

Secondary Outcome Measures

Comparison of X ray to Ultrasound in the diagnosis of post shoulder reduction complications [through study completion up to 1 year]
Compare the impression of the x ray to the ultrasound for shoulder dislocation complications

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Adults greater than or equal to 18 years
Acute shoulder dislocation

Exclusion Criteria:

Associated fracture
Associated neurovascular injury

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Rutgers, The State University of New Jersey

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jesper Aurup, MD, MD, Assistant Professor, Rutgers, The State University of New Jersey

ClinicalTrials.gov Identifier:

NCT04703517

Other Study ID Numbers:

Pro2020003069

First Posted:

Jan 11, 2021

Last Update Posted:

Jan 11, 2021

Last Verified:

Jan 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Joint Dislocations

Shoulder Dislocation

Study Results

No Results Posted as of Jan 11, 2021