Recruiting

Rotator Cuff Tears

Sponsor:

Mayo Clinic

Code:

NCT05590494

Conditions

Supraspinatus Tear

Eligibility Criteria

Sex: All

Age: 25 - 70+

Healthy Volunteers: Not accepted

Interventions

Ultrasonic tenotomy

Study Details

Brief summary:

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.

Conditions

Supraspinatus Tear

Study ID

NCT05590494

Start date

Nov 7, 2022

Status verified date

Aug, 2026

Completion date

Dec, 2028

Anticipated

Primary completion date

Dec, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 25 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

15 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: Repair a partially torn rotator cuff

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

Interventions

Ultrasonic tenotomy

Ultrasonic procedure as part of standard of care, as clinically indicated, to stimulate healing of the partial tear. The procedure uses ultrasound guidance that allows a needlelike device to gradually break up and remove tendinopathic tendon tissue.

Primary outcome measure

  • Change in pain [ Time Frame: Baseline, 2, 6, 12 and 24-weeks post-procedure ]
  • Change in shoulder active range of motion [ Time Frame: Baseline, 2, 6, 12 and 24-weeks post-procedure ]
  • Change in shoulder strength [ Time Frame: Baseline, 2, 6, 12 and 24-weeks post-procedure ]

Central Contacts and Locations

Locations

Mayo Clinic Health System - Onalaska

Recruiting

Onalaska, Wisconsin, United States, 54650

Contacts

Jacob Erickson, DO

608-392-9876erickson.jacob@mayo.edu

More Information

Sponsor

Mayo Clinic

Last update posted

Aug 5, 2026

Last verified

Aug, 2026

Keywords

  • Ultrasonic tenotomy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-08-05.