Percutaneous US Guided Elbow Tenotomy With the TenJet HydroSurgery System

Study Overview
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Brief Summary
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To evaluate the acute and long-term clinical outcomes of tenotomy with the TenJet System in patients with elbow tendinosis.

Detailed Description
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This is a prospective, non-randomized, single arm post-marketing clinical study of patients undergoing percutaneous ultrasound guided medial and lateral tenotomy using the TenJet HydroSurgery System to treat elbow tendinosis. Patients will be followed for a maximum of 12 months post-procedure.

Official Title
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Prospective Multi-Center Evaluation of Percutaneous Ultrasound Guided Elbow Tenotomy (PUGET) Using the HydroCision TenJet HydroSurgery System

Conditions
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Elbow, Tennis

Intervention / Treatment
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* Device: TenJet System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient is > 18 years of age Chronic lateral or medial elbow pain > 3 month duration History and clinical examination consistent with lateral or medial epicondylitis Sonographic evidence of medial or lateral elbow tendinosis as evidenced by tendon thickening and hypoechogenicity, with or without hypervascularity on Doppler examination and, with or without cortical irregularities, Or MRI findings consistent with lateral or medial tendinosis, with or without intrasubstance tear. > 3 months of non-operative treatment that included nonsteroidal anti-inflammatory drugs activity modification physical therapy elbow straps With or without previous steroid injections, protein rich plasma injections, or stem cell injections Patient is willing and able to provide informed consent and comply with the study protocol Exclusion Criteria: Documented ipsilateral upper extremity musculoskeletal condition (other than elbow tendinosis in the same arm on the opposite side) Bleeding disorders and/or current use of anti-coagulants with the inability to withhold anticoagulants for required time prior to procedure Use of acetylsalicylic acid (ASA) and/or non-steroidal anti-inflammatory drug (NSAID) within 7 days of treatment Steroid injection within 4 weeks of the study procedure Active local or systemic infection Patient found to have further degenerative changes of the elbow contributing to pain, such as cartilage thinning, loose body, or evidence of tendinosis other than medial or lateral, including triceps or ulnar collateral ligament. Patient is known or suspected to be pregnant

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| TenJet System<br>Percutaneous ultrasound guided medial and lateral tenotomy using the TenJet HydroSurgery System | Device: TenJet System<br>* Percutaneous ultrasound guided medial and lateral tenotomy using the TenJet HydroSurgery System<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in elbow pain using Visual Analog Scale (VAS) | Change in elbow pain VAS compared to baseline | Up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Elbow Function using the Patient-Rated Elbow Evaluation Questionnaire (PREE) | Change in PREE compared to baseline | Up to 12 months | 
| Pain medication usage | Reduction in medications for elbow pain | Up to 12 months |