Back to resultsMusculoskeletal Ultrasound for Diagnosis of Shoulder Dislocation Reduction
Primary Purpose
Ultrasound, Shoulder Dislocation, Musculoskeletal Injury
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Point of care ultrasound
Sponsored by
About this trial
This is an interventional diagnostic trial for Ultrasound
Eligibility Criteria
Inclusion Criteria:
- Adults greater than or equal to 18 years
- Acute shoulder dislocation
Exclusion Criteria:
- Associated fracture
- Associated neurovascular injury
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Self Controlled
Arm Description
Patients will active as their own comparator
Outcomes
Primary Outcome Measures
Comparison of X ray to Ultrasound for Shoulder Reduction
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
Compare the impression of the x ray to the ultrasound for shoulder dislocation complications
Full Information
NCT ID
NCT04703517
First Posted
December 16, 2020
Last Updated
January 8, 2021
Sponsor
Rutgers, The State University of New Jersey
1. Study Identification
Unique Protocol Identification Number
NCT04703517
Brief Title
Musculoskeletal Ultrasound for Diagnosis of Shoulder Dislocation Reduction
Official Title
Musculoskeletal Ultrasonography to Diagnose Successful Reduction of Shoulder Dislocation
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2021 (Anticipated)
Primary Completion Date
December 30, 2021 (Anticipated)
Study Completion Date
December 30, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rutgers, The State University of New Jersey
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ultrasound, Shoulder Dislocation, Musculoskeletal Injury
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Self Controlled
Arm Type
Other
Arm Description
Patients will active as their own comparator
Intervention Type
Diagnostic Test
Intervention Name(s)
Point of care ultrasound
Intervention Description
Patients will receive a point of care ultrasound at the bedside in the Emergency Department and compare the impression to the x ray result
Primary Outcome Measure Information:
Title
Comparison of X ray to Ultrasound for Shoulder Reduction
Description
Compare the impression of the x ray to the ultrasound for successful shoulder reduction
Time Frame
through study completion up to 1 year
Secondary Outcome Measure Information:
Title
Comparison of X ray to Ultrasound in the diagnosis of post shoulder reduction complications
Description
Compare the impression of the x ray to the ultrasound for shoulder dislocation complications
Time Frame
through study completion up to 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adults greater than or equal to 18 years
Acute shoulder dislocation
Exclusion Criteria:
Associated fracture
Associated neurovascular injury
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jesper Aurup, MD
Phone
732-258-9267
Email
ja1137@rwjms.rutgers.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Musculoskeletal Ultrasound for Diagnosis of Shoulder Dislocation Reduction
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