Advanced Imaging for Shoulder and Elbow Arthroplasty
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Duke University
- 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
