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NCT Number: NCT05590494

Novel Treatment for Rotator Cuff Tears

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.

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Key information

Conditions

Supraspinatus Tear

Age range

25 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic Health System - Onalaska

Onalaska, Wisconsin, 54650, United States

Location status: Recruiting

Location contact

Jacob Erickson, DO

CONTACT

[email protected]

608-392-9876

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Change in pain

    Time frame: Baseline, 2, 6, 12 and 24-weeks post-procedure

    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)

  2. Change in shoulder active range of motion

    Time frame: Baseline, 2, 6, 12 and 24-weeks post-procedure

    Measured using a goniometer reported in degrees

  3. Change in shoulder strength

    Time frame: Baseline, 2, 6, 12 and 24-weeks post-procedure

    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.

Secondary outcomes

  1. Change in quality of life

    Time frame: Baseline, 2, 6, 12 and 24-weeks post-procedure

    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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2028
Study completion
2028
First posted
Oct 21, 2022
Registry last updated
Aug 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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