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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

Study 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.Check my eligibility

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.See study design

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 2, 6, 12 and 24-weeks post-procedure for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in pain

Body Weight Changes

Shoulder

Secondary outcome measures

Change in quality of life

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor

3,216 Previous Clinical Trials

3,767,473 Total Patients Enrolled

Jacob Erickson, DOPrincipal InvestigatorMayo Clinic

Media Library

Ultrasonic Tenotomy (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05590494 — N/A

Supraspinatus Tear Research Study Groups: Repair a partially torn rotator cuff

Supraspinatus Tear Clinical Trial 2023: Ultrasonic Tenotomy Highlights & Side Effects. Trial Name: NCT05590494 — N/A

Ultrasonic Tenotomy (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05590494 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are any slots unoccupied in this clinical trial?

"Affirmative. Details listed on clinicaltrials.gov demonstrate that this experiment is actively seeking volunteers, with the original posting being made on November 1st 2022 and most recently updated October 19th of the same year. 15 participants are needed to be enrolled from a single site."

Answered by AI

What is the upper limit of participants for this clinical trial?

"Affirmative. Based on the information accessible from clinicaltrials.gov, this trial is actively seeking participants. It was initially published on November 1st 2022 and has been modified as recently as October 19th 2022. The study requires 15 individuals to enroll from one site."

Answered by AI

Does this clinical trial include elderly participants aged 75 and over?

"The age range to be eligible for this trial requires participants to be older than 25 and younger than 75 years old."

Answered by AI

What population would be the most suitable for participation in this trial?

"Fifteen individuals between the ages of 25 and 75 who have lipocalin 1 are allowed to enroll in this trial. Notably, applicants must provide evidence on an MRI that they possess a partial tear (< 50%) of their supraspinatus tendon."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Novel Treatment for Rotator Cuff Tears

Jacob L. Erickson 2022. "Novel Treatment for Rotator Cuff Tears". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05590494.