Treatment of Tendinosis Using the TenJet Hydroresection System

Status unconfirmed

Conditions studied: Tendinopathy, Tendinosis

In brief

Treatment of recalcitrant tendinopathy remains a clinical challenge for physicians without a minimally invasive treatment option that can consistently provide patients with a long-term relief from chronic pain and ability to return to function. Surgical debridement of degenerative tendon tissue has long been the standard of care to treat degenerative tendon pathology once all conservative or minimally invasive treatment options have failed. Ultrasound guided tenotomy is an emerging treatment option with the potential to address the underlying degenerative, diseased tissue, by selectively resecting and removing the tissue in a minimally invasive manner. Additionally, with the availability of in-office diagnostic ultrasound imaging, physicians now have an opportunity to evaluate and classify underlying tendon pathology during a clinical exam. This study is to evaluate outcomes in patients presenting with a clinical history of recalcitrant tendinopathy with confirmed diagnosis of degenerative tendinosis using diagnostic ultrasound imaging or MRI.

Key facts

Study ID

NCT05352139

Run by

Rothman Institute Orthopaedics

People needed

600

Starts

2022-05-01

Expected to finish

2025-04-30

Last updated by the study team

2024-06-21

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Patient is 18 - 70 years of age
• Chronic tendon pain ≥ 3 months duration
• History and clinical examination consistent with tendinosis
• Sonographic or MRI confirmation of tendinosis
• 3 months of conservative treatment
• Patient is willing and able to provide informed consent and comply with the study protocol

You may not qualify if…

• Full thickness tear of the tendon
• Unable to withhold anticoagulants 7 days prior to the procedure.
• Use above 81mg/day of acetylsalicyclic acid (ASA) and/or non-steroidal anti-inflammatory drug (NSAID) within 7 days of treatment
• Steroid, PRP, Stem cell or biologic injections within 3 months of the study procedure date
• Needle tenotomy, Tenex, or surgical interventions within 6 months of study procedure date
• Active local or systemic infection requiring antiviral, antibacterial or antifungal treatment
• Chronic conditions such as CRPS or fibromyalgia that might affect pain symptoms.

Where it is running

• Standford Medicine — Redwood City, California, United States
• Cleveland Clinic — Coral Springs, Florida, United States
• Ochsner Health — Baton Rouge, Louisiana, United States
• University of North Carolina — Chapel Hill, North Carolina, United States
• Cleveland Clinic — Lorain, Ohio, United States
• Penn Highlands Orthopedics and Sports Medicine — Clarion, Pennsylvania, United States
• Rothman Orthopaedic Institute — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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