Actively Recruiting
Ultrasonic Tenotomy as a Treatment of Partial Rotator Cuff Tear of the Supraspinatus Tendon: A Pilot Feasibility Study
Led by Mayo Clinic · Updated on 2025-08-01
15
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to study changes in pain levels, strength, and shoulder movement after using ultrasonic tenotomy to treat a partial tear (less than 50%) of the supraspinatus tendon in the rotator cuff. The study focuses on measuring these changes over time to better understand the effects of this treatment on the affected shoulder. Participants will receive an ultrasonic tenotomy procedure, which is part of the standard care and guided by ultrasound. This procedure uses a needlelike device to gently break up and remove damaged tendon tissue to encourage healing of the partial tear. This treatment is provided as clinically needed for repairing the rotator cuff tear. During the study, participants will be assessed at the start and then at 2, 6, 12, and 24 weeks after the procedure. Researchers will measure pain, shoulder active range of motion, and strength at these time points. They will also evaluate changes in quality of life over the same periods. The total duration of participation includes these follow-up assessments to monitor recovery and outcomes.
CONDITIONS
Brief Title
Novel Treatment for Rotator Cuff Tears
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Evidence of partial tear (< 50%) of the supraspinatus tendon on MRI
- Age between 25 and 75 years
You will not qualify if you...
- Tear of the supraspinatus tendon greater than 50% or full thickness tear
- Concomitant tears greater than 25% of other rotator cuff tendons (infraspinatus, teres minor, or subscapularis)
- Acute tear of the glenoid labrum
- Systemic illness or infection requiring oral or IV antibiotics during recruitment
- Overlying skin infection or lesion at the device insertion point on the shoulder
- Previous corticosteroid injection within three months
- Age less than 25 or greater than 75 years
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single procedure with follow-up to 24 weeks
Participants undergo an ultrasonic tenotomy procedure to repair a partially torn rotator cuff as clinically indicated.
1 procedure visit and 5 follow-up visits at 2, 6, 12, and 24 weeks post-procedure
Trial Site Locations
Total: 1 location
1
Mayo Clinic Health System - Onalaska
Onalaska, Wisconsin, United States, 54650
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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