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

Trial Summary

What is the purpose of this trial?

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.

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 data supports the idea that Ultrasonic Tenotomy for Rotator Cuff Tears is an effective treatment?

The available research shows that Ultrasonic Tenotomy has been studied for other conditions like lateral epicondylitis and has shown positive outcomes. For example, one study found that it was effective in treating lateral epicondylitis, a condition similar to rotator cuff tears, with good safety and early success. Another study tested the procedure on the long head of the biceps tendon in patients with rotator cuff tears and found it technically feasible, suggesting potential benefits for rotator cuff tears as well. ^{1 2 3 4 5}

What safety data exists for ultrasonic tenotomy for rotator cuff tears?

The safety data for ultrasonic tenotomy, also known as the Tenex procedure, PUT, or PCNT, indicates that it is generally well-tolerated and safe. Studies have shown positive outcomes for similar procedures, such as those for lateral epicondylitis and patellar tendinosis, with good tolerability and early efficacy. Although specific safety data for rotator cuff tears is not detailed, the technique's use in other tendon-related conditions suggests a favorable safety profile. ^{1 2 3 4 5}

Is Ultrasonic Tenotomy a promising treatment for Rotator Cuff Tears?

Yes, Ultrasonic Tenotomy is a promising treatment. It is a minimally-invasive procedure that uses sound waves to treat tendon issues. Studies show it is effective, safe, and well-tolerated, offering a good alternative to surgery for certain tendon problems. ^{1 2 3 4 5}

Research Team

Jacob Erickson, DO

Principal Investigator

Mayo Clinic

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Percutaneous ultrasonic tenotomy effectively debrides tendons of the extensor mechanism of the knee: A technical note. [2020]

2. Germany 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. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Ultrasonic Percutaneous Tenotomy for Recalcitrant Lateral Elbow Tendinopathy: Sustainability and Sonographic Progression at 3 Years. [2022]

4. Switzerland 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. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Feasibility of ultrasound-guided percutaneous tenotomy of the long head of the biceps tendon--A pilot cadaveric study. [2022]