RecruitingNot ApplicableNCT05590494

Novel Treatment for Rotator Cuff Tears

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


Sponsor

Mayo Clinic

Enrollment

15 participants

Start Date

Nov 7, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 25 YearsMax Age: 75 Years

Inclusion Criteria1

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

Exclusion Criteria5

  • 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.

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Interventions

PROCEDUREUltrasonic 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.


Locations(1)

Mayo Clinic Health System - Onalaska

Onalaska, Wisconsin, United States

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NCT05590494


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