Novel Treatment for Rotator Cuff Tears
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ultrasonic tenotomy.
- Who it may be relevant to
- Registry conditions: Supraspinatus Tear. Basic parameters: 25 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Ultrasonic Tenotomy as a Treatment of Partial Rotator Cuff Tear of the Supraspinatus Tendon: A Pilot Feasibility Study
Overview
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.
Interventions
- 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.
Primary outcome measures
- Change in pain [Time frame: Baseline, 2, 6, 12 and 24-weeks post-procedure]
- Change in shoulder active range of motion [Time frame: Baseline, 2, 6, 12 and 24-weeks post-procedure]
- Change in shoulder strength [Time frame: Baseline, 2, 6, 12 and 24-weeks post-procedure]
Secondary outcome measures (1)
- Change in quality of life [Time frame: Baseline, 2, 6, 12 and 24-weeks post-procedure]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Mayo Clinic Health System - Onalaska — Onalaska
Identifiers
NCT: NCT05590494 · 21-011522