Novel Treatment for Rotator Cuff Tears

Supraspinatus Tear Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05590494
• Other study ID #: 21-011522
• Status: Recruiting
• Phase: N/A
• Start date: November 7, 2022
• Est. completion date: June 2024

Study information

• Verified date: March 2024
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Rotator Cuff Injuries
• Supraspinatus Tear

Intervention

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.

Locations

Country	Name	City	State
United States	Mayo Clinic Health System - Onalaska	Onalaska	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Change in shoulder active range of motion	Measured using a goniometer reported in degrees	Baseline, 2, 6, 12 and 24-weeks post-procedure
Primary	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	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