Novel Treatment for Rotator Cuff Tears

NCT05590494 | Recruiting

• 1 other identifier: 21-011522
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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

Keywords

Ultrasonic tenotomy

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Change in quality of life

  Baseline, 2, 6, 12 and 24-weeks post-procedure

Study Arms (1)

Repair a partially torn rotator cuff

OTHER

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

Procedure: Ultrasonic tenotomy

Interventions

Ultrasonic tenotomy PROCEDURE

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.

Repair a partially torn rotator cuff

Eligibility Criteria

• Age: 25 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Evidence of partial tear (\< 50%) of the supraspinatus tendon on MRI.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic Health System - Onalaska

Onalaska, Wisconsin, 54650, United States

RECRUITING

Related Links

• Mayo Clinic Clinical Trials

Study Officials

• Jacob Erickson, DO

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 19, 2022
• First Posted: October 21, 2022
• Study Start: November 7, 2022
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: August 1, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)