Ultrasonic Tenotomy for Rotator Cuff Tears

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Must not be taking: Antibiotics, Corticosteroids

Disqualifiers: Tendon tears, Systemic illness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 6

Duration: 1 day

15 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a treatment called ultrasonic tenotomy, a minimally invasive procedure, to aid individuals with a partial tear (less than 50%) in their rotator cuff, specifically the supraspinatus tendon. The researchers aim to assess how this treatment affects pain, strength, and shoulder movement over time. Participants must have a partial tear confirmed by an MRI and experience issues like shoulder pain or limited movement due to the tear. This trial excludes those with larger tears or recent infections. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance treatment options for shoulder injuries.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, if you have had a corticosteroid injection in the last three months, you cannot participate.

What prior data suggests that this ultrasonic tenotomy is safe for repairing a partially torn rotator cuff?

Research has shown that ultrasonic tenotomy is generally well-tolerated. In one study, about 74% of patients reported complete satisfaction with their procedure, and 80% said they would recommend it to a friend. This suggests that most people had a positive experience. Other studies have found that ultrasonic tenotomy is a safe and effective way to treat tendon problems. As a minimally invasive treatment, it uses small cuts and usually results in less pain and a quicker recovery. While no treatment is without risk, the available evidence indicates that ultrasonic tenotomy is a safe choice for many people with tendon issues. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional treatments for rotator cuff tears, such as physical therapy, corticosteroid injections, or surgical repair, ultrasonic tenotomy uses high-frequency sound waves to target and break down scar tissue. This technique is minimally invasive and aims to accelerate healing by promoting tissue regeneration directly at the site of injury. Researchers are excited because it potentially offers quicker recovery times and less pain compared to conventional methods, making it a promising alternative for patients with partially torn rotator cuffs.

What evidence suggests that ultrasonic tenotomy is effective for rotator cuff tears?

Research has shown that ultrasonic tenotomy, the treatment being studied in this trial, can help treat partial tears in the rotator cuff. In one study, about 74% of patients were completely satisfied with the procedure, and 80% would recommend it to others. This treatment also provides long-lasting pain relief and improves shoulder function. Another study found that ultrasonic tenotomy is both safe and effective for similar tendon problems. Overall, this treatment appears promising for reducing pain and improving shoulder movement in people with partial rotator cuff tears. ^{1 2 3 6 7}

Who Is on the Research Team?

Jacob Erickson, DO

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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

Exclusion 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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo an ultrasonic tenotomy to repair a partially torn rotator cuff

1 day

1 visit (in-person)

Follow-up

Participants are monitored for changes in pain, strength, and range of motion post-procedure

24 weeks

5 visits (in-person) at 2, 6, 12, and 24 weeks post-procedure

What Are the Treatments Tested in This Trial?

Interventions

• Ultrasonic Tenotomy

Trial Overview 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.

How Is the Trial Designed?

Group I: Repair a partially torn rotator cuff Experimental Treatment 1 Intervention

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

Ultrasonic Tenotomy is already approved in United States for the following indications:

Approved in United States as Tenex procedure for:

• Rotator cuff tendinitis
• Achilles tendonitis
• Knee tendonitis
• Elbow tendonitis
• Hip tendonitis
• Plantar fasciitis

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Published Research Related to This Trial

Percutaneous ultrasonic tenotomy (PUT) effectively debrided the treatment area in all four cadaveric tendons studied, demonstrating its potential as a minimally-invasive method for treating patellar tendinosis.

The procedure did not damage surrounding tissue, indicating a favorable safety profile, but further research is needed to evaluate clinical outcomes and the risk of post-procedure complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Percutaneous ultrasonic tenotomy effectively debrides tendons of the extensor mechanism of the knee: A technical note. Baria, MR., Vasileff, WK., Miller, M., et al.[2020]

The ultrasound-guided percutaneous tenotomy technique for the long head of the biceps tendon (LHBT) was successfully performed on three cadavers, demonstrating feasibility with four out of six tendons fully transected.

The study found no iatrogenic injuries, indicating that this technique may be safe, and the deep to superficial approach using an arthroscopic hook blade was particularly effective for complete transection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of ultrasound-guided percutaneous tenotomy of the long head of the biceps tendon--A pilot cadaveric study. Aly, AR., Rajasekaran, S., Mohamed, A., et al.[2022]

Ultrasound-guided percutaneous tenotomy of the long head of biceps tendon (LHBT) was performed on 11 patients with symptomatic rotator cuff tears, showing significant pain reduction from a pre-procedure score of 8.2 to 2.8 after six months (p < 0.001).

The procedure was technically feasible, with a mean duration of 65 seconds and minimal complications; all patients reported satisfaction with the treatment, indicating it as an effective option for those unable to undergo traditional surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultrasound-Guided Percutaneous Tenotomy of the Long Head of Biceps Tendon in Patients with Symptomatic Complete Rotator Cuff Tear: In Vivo Non-contRolled Prospective Study. Sconfienza, LM., Albano, D., Messina, C., et al.[2020]

A follow-up study of 20 patients who underwent percutaneous ultrasonic tenotomy for tennis elbow showed sustained pain relief and functional improvement after 3 years, with 100% satisfaction and no need for further treatments.

Ultrasound imaging revealed significant healing, with 94% of patients showing resolved tendon hypervascularity and 100% experiencing reduced tendon thickness, indicating effective tissue healing and making this technique a promising alternative to surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultrasonic Percutaneous Tenotomy for Recalcitrant Lateral Elbow Tendinopathy: Sustainability and Sonographic Progression at 3 Years. Seng, C., Mohan, PC., Koh, SB., et al.[2022]

Ultrasound-guided percutaneous needle tenotomy (USPNT) using the Tenex system significantly improves symptoms and function in patients with lateral epicondylitis (LE), with benefits lasting up to 3 years after treatment, based on a study of 37 patients over an average follow-up of 531 days.

No serious complications were reported, such as tendon ruptures or infections, indicating that USPNT is a safe alternative to surgical intervention for LE, especially when combined with post-procedure physical therapy, which enhances treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultrasound-guided percutaneous needle tenotomy using Tenex system for refractory lateral epicondylitis; short and long-term effectiveness and contributing factors. Chalian, M., Nacey, NC., Rawat, U., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11073761/

The Effects of Ultrasound-Guided Percutaneous Tenotomy ... About 74% of patients were completely satisfied with the procedure, and 80% received enough benefit to recommend it to a friend. Conclusions: ...

2. journaloei.scholasticahq.com journaloei.scholasticahq.com/article/88229-structural-and-clinical-outcomes-after-tenex-debridement-for-rotator-cuff-tendinopathy

Structural and Clinical Outcomes after Tenex Debridement for ... Our study evaluates the use of percutaneous ultrasonic debridement (percutaneous ultrasonic tenotomy (PUT)) of tendinopathy lesions for rotator ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7594229/

Ultrasonic Tenotomy and Debridement for Calcific ... Ultrasonic tenotomy and debridement appears to be a safe and effective treatment option for patients with calcific tendinopathy of the supraspinatus.

4. hopkinsmedicine.org hopkinsmedicine.org/health/treatment-tests-and-therapies/percutaneous-needle-tenotomy-for-tendon-injuries

Percutaneous Needle Tenotomy for Tendon Injuries Studies show that pain relief and functional improvement may last for up to three years after percutaneous needle tenotomy. But for some people, the pain ...

5. rps.researchcommons.org rps.researchcommons.org/cgi/viewcontent.cgi?article=2265&context=journal

Ultrasound-Guided Percutaneous Needle Barbotage and ... Among these, ultrasound- guided needle barbotage is a well-estab- lished, minimally invasive technique that provides pain relief and promotes ...

6. wa-provider.kaiserpermanente.org wa-provider.kaiserpermanente.org/static/pdf/hosting/clinical/criteria/pdf/tenex.pdf

Tenex | Clinical Review Criteria The Tenex system is a surgical instrument that uses ultrasonic energy to perform a percutaneous tenotomy and fasciotomy. It is intended to precisely cut and ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11569693/

Effectiveness of Percutaneous Needle Tenotomy for ... PNT and TENEX are safe, beneficial, and minimally invasive treatment option for patients, especially for conditions refractory to more conservative treatments ...