Clinical trial NCT04416932: Ultrasound After Total Shoulder Arthroplasty
Official title: Advanced Imaging for Shoulder and Elbow Arthroplasty
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Total Shoulder Arthroplasty
Rotator Cuff Tears
Rotator Cuff Injuries
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Piedmont Orthopedic Society
First posted: 2020-06-04
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Duke patients who have had prior total shoulder arthroplasy surgery within the past 5 years who are 18 years of age or older.

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.


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

Primary outcomes:
measure: Number of confirmed healed rotator cuff tear as measured by ultrasound
timeFrame: time of procedure, up to 1 hour
measure: Number of confirmed non-healed tenotomy
timeFrame: time of procedure, up to 1 hour
measure: Number of confirmed rotator cuff tears
timeFrame: time of procedure, up to 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Christopher Klifto, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Karthikeyan S, Rai SB, Parsons H, Drew S, Smith CD, Griffin DR. Ultrasound dimensions of the rotator cuff in young healthy adults. J Shoulder Elbow Surg. 2014 Aug;23(8):1107-12. doi: 10.1016/j.jse.2013.11.012. Epub 2014 Jan 16.
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