New treatment for partial rotator cuff tears
Ultrasonic Tenotomy as a Treatment of Partial Rotator Cuff Tear of the Supraspinatus Tendon: A Pilot Feasibility Study
This study is testing a new procedure called ultrasonic tenotomy to see if it can help people with partial rotator cuff tears feel less pain and move their shoulders better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 25 Years to 75 Years |
| Sex | All |
| Sponsor | Mayo Clinic Academic / other |
| Locations | 1 site (Onalaska, Wisconsin) |
| Trial ID | NCT05590494 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of ultrasonic tenotomy in treating partial tears of the supraspinatus tendon, specifically those less than 50% in size. Participants will undergo the procedure and be monitored over time for changes in pain levels, strength, and range of motion in the affected shoulder. The goal is to assess the potential benefits of this innovative approach in improving patient outcomes.
Who should consider this trial
Good fit: Ideal candidates are individuals with a partial tear of the supraspinatus tendon confirmed by MRI, specifically those with tears less than 50%.
Not a fit: Patients with full thickness tears or other significant shoulder injuries will not benefit from this treatment.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce pain and improve shoulder function for patients with partial rotator cuff tears.
How similar studies have performed: While ultrasonic tenotomy is a relatively novel approach, similar studies have shown promising results in improving outcomes for tendon injuries.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: \- Evidence of partial tear (\< 50%) of the supraspinatus tendon on MRI. Exclusion Criteria: * A tear of the supraspinatus tendon greater \> 50% and any areas of full thickness tearing, concomitant tears \> 25% of other rotator cuff tendons (infraspinatus, teres minor or subscapularis), or acute tear of the glenoid labrum. * Evidence of systemic illness/infection requiring oral or IV antibiotics during the recruitment period. * Evidence of overlying skin infection or lesion at the proposed device insertion point on the shoulder. * Previous corticosteroid injection within three months. * Those individuals less than 25 and greater than 75 years of age will be excluded.
Where this trial is running
Onalaska, Wisconsin
- Mayo Clinic Health System - Onalaska — Onalaska, Wisconsin, United States (Recruiting)
Study contacts
- Principal investigator: Jacob Erickson, DO — Mayo Clinic
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.