Treatment of Tendinosis Using the TenJet Hydroresection System

Launched by ROTHMAN INSTITUTE ORTHOPAEDICS · Apr 25, 2022

Keywords

ClinConnect Summary

This is a multi-center, observational registry study that will follow about 600 adults to see how well a minimally invasive procedure called the Hydrocision TenJet system works for chronic tendinopathy (degenerative tendon changes) in the elbow, hip, or shoulder. Doctors will collect real-world data from people who undergo the TenJet procedure, tracking them for up to 2 years to see if pain improves and if they can return to daily activities or sports. No results are published yet; this study is about gathering information as patients receive standard care.

Who can join? Adults aged 18–70 with long-lasting tendinosis in the elbow, hip, or shoulder confirmed by ultrasound or MRI, who have already tried at least 3 months of conservative treatment. You must not have a full-thickness tendon tear, and you must be able to pause certain medications around the procedure. If you’re invited and eligible, you would have the TenJet tissue-resection procedure, which uses pressurized saline to remove damaged tissue while aiming to spare healthy tendon tissue. Afterward, you would complete follow-up visits and surveys over 2 years to track pain, function, and overall quality of life. The trial is sponsored by the Rothman Institute and conducted at several U.S. centers.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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
• Exclusion Criteria:
• • 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.