Novel Treatment for Rotator Cuff Tears

Mayo Clinic

Status: Enrolling

Conditions: Supraspinatus Tear

Treatments: Procedure: Ultrasonic tenotomy

Study type: Interventional

Funder types: Other

Identifiers

NCT05590494

21-011522

Details and patient eligibility

About

The focus of this study is to examine changes in pain scores, strength, and range of motion over time following an ultrasonic tenotomy on a partial tear (<50%) of the supraspinatus tendon of the rotator cuff.

Enrollment: 15 estimated patients

Sex: All

Ages: 25 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Repair a partially torn rotator cuff

Other group

Description:

Subjects will undergo an ultrasonic tenotomy to repair a partially torn rotator cuff per standard of care as clinically indicated

Treatment:

Procedure: Ultrasonic tenotomy