Novel Treatment for Rotator Cuff Tears

Not Applicable

Recruiting

• Conditions: Supraspinatus Tear
• Interventions: Procedure: Ultrasonic tenotomy

• Registration Number: NCT05590494
• Lead Sponsor: Mayo Clinic

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2022-10-19
• Study First Submitted QC: 2022-10-19
• Study First Posted: 2022-10-21
• Study Start: 2022-11-07
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-15
• Last Update Posted: 2024-08-16
• Primary Completion: 2025-06
• Study Completion: 2026-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Change in pain	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)
Change in shoulder active range of motion	Baseline, 2, 6, 12 and 24-weeks post-procedure	Measured using a goniometer reported in degrees
Change in shoulder strength	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 Outcome Measures

Name	Time	Method
Change in quality of life	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.

Trial Locations

Locations (1)

Mayo Clinic Health System - Onalaska; 🇺🇸 Onalaska, Wisconsin, United States