Novel Treatment for Rotator Cuff Tears

Ultrasonic Tenotomy as a Treatment of Partial Rotator Cuff Tear of the Supraspinatus Tendon: A Pilot Feasibility Study

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.

Study Overview

• Status: Recruiting
• Conditions: Supraspinatus Tear
• Intervention / Treatment: Procedure: Ultrasonic tenotomy

• Study Type: Interventional
• Enrollment (Estimated): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Onalaska, Wisconsin, United States, 54650
      • Recruiting
      • Mayo Clinic Health System - Onalaska
      • Contact: Jacob Erickson, DO; Phone Number: 608-392-9876; Email: erickson.jacob@mayo.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 71 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in pain	Measured using a visual analog scale (VAS), used to measure subjective pain, rated from 0 (no pain) to 100 (most severe pain) at rest and during activity (previously painful activities)	Baseline, 2, 6, 12 and 24-weeks post-procedure
Change in shoulder active range of motion	Measured using a goniometer reported in degrees	Baseline, 2, 6, 12 and 24-weeks post-procedure
Change in shoulder strength	Assessed using a hand-held dynamometer (HHD) placed distally on the forearm, just proximal to the wrist joint along the distal radius and ulna with instruction to push into the HHD with maximum force production for approximately 5 seconds.	Baseline, 2, 6, 12 and 24-weeks post-procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in quality of life	Measured using the SF-36 Quality of Life questionnaire which is a 36-item self-reported health survey that measures health and disability. Possible scores range from 0 to 100, with 0 indicating maximum disability, and 100 indicating no disability.	Baseline, 2, 6, 12 and 24-weeks post-procedure

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Jacob Erickson, DO, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): November 7, 2022
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: October 19, 2022
• First Submitted That Met QC Criteria: October 19, 2022
• First Posted (Actual): October 21, 2022

Study Record Updates

• Last Update Posted (Actual): August 1, 2025
• Last Update Submitted That Met QC Criteria: July 29, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Ultrasonic tenotomy
• Additional Relevant MeSH Terms: Shoulder Injuries; Wounds and Injuries; Rupture; Tendon Injuries; Rotator Cuff Injuries
• Other Study ID Numbers: 21-011522

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No