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Ultrasonic Tenotomy for Rotator Cuff Tears
N/A
Recruiting
Led By Jacob Erickson, DO
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 2, 6, 12 and 24-weeks post-procedure
Awards & highlights
No Placebo-Only Group
Summary
This trial looks at how well ultrasonic tenotomy helps heal rotator cuff tears, helping with pain, strength and range of motion.
Who is the study for?
This trial is for individuals with a partial tear in the supraspinatus tendon of the rotator cuff, confirmed by MRI. It's not suitable for those with tears greater than 50%, other significant rotator cuff tears, skin infections at the treatment site, people outside the age range of 25-75 years, recent corticosteroid injections, or systemic illness requiring antibiotics.
What is being tested?
The study tests ultrasonic tenotomy on patients with less than a 50% tear in their supraspinatus tendon. It aims to assess changes in pain levels, muscle strength and joint movement over time after this minimally invasive procedure.
What are the potential side effects?
Potential side effects may include discomfort at the treatment site, swelling or bruising around the shoulder area. There could also be temporary weakness or limited motion due to procedural irritation.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 2, 6, 12 and 24-weeks post-procedure
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 2, 6, 12 and 24-weeks post-procedure
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in pain
Body Weight Changes
Shoulder
Secondary study objectives
Change in quality of life
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Repair a partially torn rotator cuffExperimental Treatment1 Intervention
Subjects will undergo an ultrasonic tenotomy to repair a partially torn rotator cuff per standard of care as clinically indicated
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Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,350 Previous Clinical Trials
3,060,659 Total Patients Enrolled
Jacob Erickson, DOPrincipal InvestigatorMayo Clinic
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have no skin infections or lesions where the device would be inserted on my shoulder.I am currently on antibiotics for a systemic illness or infection.I have a significant tear in my shoulder tendon.I have a recent tear in the shoulder cartilage.I have not had a corticosteroid injection in the last three months.I have significant tears in other shoulder tendons besides the one being studied.I am between 25 and 75 years old.
Research Study Groups:
This trial has the following groups:- Group 1: Repair a partially torn rotator cuff
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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