Novel Treatment for Rotator Cuff Tears

Study Overview
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Brief Summary
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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.

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

Conditions
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Supraspinatus Tear

Intervention / Treatment
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* Procedure: Ultrasonic tenotomy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Repair a partially torn rotator cuff<br>Subjects will undergo an ultrasonic tenotomy to repair a partially torn rotator cuff per standard of care as clinically indicated | Procedure: Ultrasonic tenotomy<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ultrasonic tenotomy