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Clinical Trials/NCT04416932
NCT04416932
Completed
Not Applicable

Advanced Imaging for Shoulder and Elbow Arthroplasty

Duke University1 site in 1 country12 target enrollmentMay 20, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Total Shoulder Arthroplasty
Sponsor
Duke University
Enrollment
12
Locations
1
Primary Endpoint
Number of confirmed healed rotator cuff tear as measured by ultrasound
Status
Completed
Last Updated
last year

Overview

Brief Summary

The purpose of this study would be to evaluate a group of patients status post post-total shoulder arthroplasty to assess the integrity of the rotator cuff using ultrasound. We believe ultrasonography imaging to be a comparable and efficacious modality to evalute tenotomy healing rates and diagnose rotator cuff failure after total shoulder arthroplasty. In addition, we believe ultrasonography to be a cost-effective modality to asses the rotator cuff after total shoulder arthroplasty. Our population would consist of patients that received total shoulder arthroplasty within the last 5 years.

Registry
clinicaltrials.gov
Start Date
May 20, 2021
End Date
March 22, 2023
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Primary or revision total shoulder arthroplasty with or without subscapularis tenotomy
  • Primary or revision reverse shoulder arthroplasty with or without subscapularis tenotomy
  • English speaking patients only
  • Shoulder arthroplasty within the last 5 years

Exclusion Criteria

  • Revision shoulder arthroplasty for infection
  • Pregnancy

Outcomes

Primary Outcomes

Number of confirmed healed rotator cuff tear as measured by ultrasound

Time Frame: time of procedure, up to 1 hour

Number of confirmed non-healed tenotomy

Time Frame: time of procedure, up to 1 hour

Number of confirmed rotator cuff tears

Time Frame: time of procedure, up to 1 hour

Study Sites (1)

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