Treatment of Tendinosis Using the TenJet Hydroresection System

Study Overview
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Brief Summary
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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.

Official Title
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Prospective Multi-Center Patient Registry for Patients With Elbow, Hip, and Calcific Shoulder Tendinosis Treated Utilizing the TenJet Hydroresection System

Conditions
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Tendinopathy, Tendinosis

Intervention / Treatment
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* Procedure: Resection (removal) of the degenerative tissue using the Hydrocision TenJet system
* Device: Hydrocision Tenjet System


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Elbow Tendinosis (Epicondylitis)<br>Treatment of participants who present with either lateral or medial epicondylitis | Procedure: Resection (removal) of the degenerative tissue using the Hydrocision TenJet system<br>* During the procedure, the TenJet device will remove degenerative tendinopathic tissue using pressurized saline without causing harm to the healthy tendon fibers.<br>Device: Hydrocision Tenjet System<br>* The TenJet system will be used during surgery to remove the damaged tissue from the joint<br>|
| Hip Tendinosis (Gluteal Tendinopathy)<br>Treatment of participants diagnosed with Recalcitrant Gluteal Tendinopathy | Procedure: Resection (removal) of the degenerative tissue using the Hydrocision TenJet system<br>* During the procedure, the TenJet device will remove degenerative tendinopathic tissue using pressurized saline without causing harm to the healthy tendon fibers.<br>Device: Hydrocision Tenjet System<br>* The TenJet system will be used during surgery to remove the damaged tissue from the joint<br>|
| Shoulder Calcific Tendinosis (Calcific Shoulder Tendinopathy)<br>Treatment of participants diagnosed with Calcific Shoulder Tendinopathy | Procedure: Resection (removal) of the degenerative tissue using the Hydrocision TenJet system<br>* During the procedure, the TenJet device will remove degenerative tendinopathic tissue using pressurized saline without causing harm to the healthy tendon fibers.<br>Device: Hydrocision Tenjet System<br>* The TenJet system will be used during surgery to remove the damaged tissue from the joint<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain reduction | Using the Visual Analog Scale for Pain (VAS) participants will be asked to report their pain score after surgery | 2 years | 
| Return to function (Elbow #1) | This will be measured in participants undergoing treatment for Elbow Tendinopathy using the Mayo Elbow Performance Score (MEPS) | 2 years | 
| Return to function (Elbow #2) | This will be measured in participants undergoing treatment for Elbow Tendinopathy using the Patient-Rated Tennis Elbow Evaluation (PRTEE) survey | 2 years | 
| Return to function (Elbow #3) | This will be measured in participants undergoing treatment for Elbow Tendinopathy using the Quick Disability Arm, Shoulder and Hand (QDASH) survey | 2 years | 
| Return to function (All cohorts) | This will be measured in participants undergoing treatment for Elbow, Hip and Shoulder Tendinopathy using the Short Form Health Survey (SF-12) survey | 2 years | 
| Return to Function (Hip) | This will be measured in participants undergoing treatment for Hip Tendinopathy using the Victorian Institute of Sport Assessment-Gluteal Questionnaire (VISA-G) survey | 2 years | 
| Return to Function (Shoulder) | This will be measured in participants undergoing treatment for Shoulder Tendinopathy using the American Shoulder & Elbow Score (ASES) survey | 2 years |