Treatment of Tendinosis Using the TenJet Hydroresection System
- Conditions
- TendinosisTendinopathy
- Interventions
- Procedure: Resection (removal) of the degenerative tissue using the Hydrocision TenJet systemDevice: Hydrocision Tenjet System
- Registration Number
- NCT05352139
- Lead Sponsor
- Rothman Institute Orthopaedics
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 600
- 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
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Elbow Tendinosis (Epicondylitis) Resection (removal) of the degenerative tissue using the Hydrocision TenJet system Treatment of participants who present with either lateral or medial epicondylitis Shoulder Calcific Tendinosis (Calcific Shoulder Tendinopathy) Hydrocision Tenjet System Treatment of participants diagnosed with Calcific Shoulder Tendinopathy Shoulder Calcific Tendinosis (Calcific Shoulder Tendinopathy) Resection (removal) of the degenerative tissue using the Hydrocision TenJet system Treatment of participants diagnosed with Calcific Shoulder Tendinopathy Hip Tendinosis (Gluteal Tendinopathy) Hydrocision Tenjet System Treatment of participants diagnosed with Recalcitrant Gluteal Tendinopathy Hip Tendinosis (Gluteal Tendinopathy) Resection (removal) of the degenerative tissue using the Hydrocision TenJet system Treatment of participants diagnosed with Recalcitrant Gluteal Tendinopathy Elbow Tendinosis (Epicondylitis) Hydrocision Tenjet System Treatment of participants who present with either lateral or medial epicondylitis
- Primary Outcome Measures
Name Time Method Return to function (Elbow #2) 2 years This will be measured in participants undergoing treatment for Elbow Tendinopathy using the Patient-Rated Tennis Elbow Evaluation (PRTEE) survey
Return to function (Elbow #1) 2 years This will be measured in participants undergoing treatment for Elbow Tendinopathy using the Mayo Elbow Performance Score (MEPS)
Pain reduction 2 years Using the Visual Analog Scale for Pain (VAS) participants will be asked to report their pain score after surgery
Return to function (Elbow #3) 2 years This will be measured in participants undergoing treatment for Elbow Tendinopathy using the Quick Disability Arm, Shoulder and Hand (QDASH) survey
Return to function (All cohorts) 2 years This will be measured in participants undergoing treatment for Elbow, Hip and Shoulder Tendinopathy using the Short Form Health Survey (SF-12) survey
Return to Function (Hip) 2 years This will be measured in participants undergoing treatment for Hip Tendinopathy using the Victorian Institute of Sport Assessment-Gluteal Questionnaire (VISA-G) survey
Return to Function (Shoulder) 2 years This will be measured in participants undergoing treatment for Shoulder Tendinopathy using the American Shoulder \& Elbow Score (ASES) survey
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (6)
Cleveland Clinic
🇺🇸Lorain, Ohio, United States
Ochsner Health
🇺🇸Baton Rouge, Louisiana, United States
Rothman Orthopaedic Institute
🇺🇸Philadelphia, Pennsylvania, United States
Standford Medicine
🇺🇸Redwood City, California, United States
Penn Highlands Orthopedics and Sports Medicine
🇺🇸Clarion, Pennsylvania, United States
University of North Carolina
🇺🇸Chapel Hill, North Carolina, United States