Skip to main content
Clinical Trials/NCT04416932
NCT04416932CompletedNot Applicable

Advanced Imaging for Shoulder and Elbow Arthroplasty

Duke University1 site in 1 country12 target enrollmentStarted: May 20, 2021Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
12
Locations
1
Primary Endpoint
Number of confirmed healed rotator cuff tear as measured by ultrasound

Study 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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

Loading locations...

Similar Trials

Ultrasound After Total Shoulder... | Clinical Trial