NCT04703517

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2021

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 16, 2020

Completed
16 days until next milestone

Study Start

First participant enrolled

January 1, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 11, 2021

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2021

Completed
Last Updated

January 11, 2021

Status Verified

January 1, 2021

Enrollment Period

12 months

First QC Date

December 16, 2020

Last Update Submit

January 8, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Comparison of X ray to Ultrasound for Shoulder Reduction

    Compare the impression of the x ray to the ultrasound for successful shoulder reduction

    through study completion up to 1 year

Secondary Outcomes (1)

  • Comparison of X ray to Ultrasound in the diagnosis of post shoulder reduction complications

    through study completion up to 1 year

Study Arms (1)

Self Controlled

OTHER

Patients will active as their own comparator

Diagnostic Test: Point of care ultrasound

Interventions

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

Self Controlled

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults greater than or equal to 18 years
  • Acute shoulder dislocation

You may not qualify if:

  • Associated fracture
  • Associated neurovascular injury

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Shoulder Dislocation

Condition Hierarchy (Ancestors)

Joint DislocationsJoint DiseasesMusculoskeletal DiseasesWounds and InjuriesShoulder Injuries

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Assistant Professor

Study Record Dates

First Submitted

December 16, 2020

First Posted

January 11, 2021

Study Start

January 1, 2021

Primary Completion

December 30, 2021

Study Completion

December 30, 2021

Last Updated

January 11, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share