Treatment of Tendinosis Using the TenJet Hydroresection System

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Tendinopathy; Tendinosis
• Intervention / Treatment: Procedure: Resection (removal) of the degenerative tissue using the Hydrocision TenJet system; Device: Hydrocision Tenjet System

• Study Type: Observational
• Enrollment (Estimated): 600

Contacts and Locations

Study Locations

• United States
  • California
    • Redwood City, California, United States, 94063
      • Standford Medicine
  • Florida
    • Coral Springs, Florida, United States, 33067
      • Cleveland Clinic
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70836
      • Ochsner Health
  • North Carolina
    • Chapel Hill, North Carolina, United States, 28223
      • University of North Carolina
  • Ohio
    • Lorain, Ohio, United States, 44053
      • Cleveland Clinic
  • Pennsylvania
    • Clarion, Pennsylvania, United States, 16214
      • Penn Highlands Orthopedics and Sports Medicine
    • Philadelphia, Pennsylvania, United States, 19107
      • Rothman Orthopaedic Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Patients between 18-70 years old presenting with chronic, refractory lateral and medial elbow, hip, or shoulder pain, secondary to tendinosis.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Rothman Institute Orthopaedics

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2022
• Primary Completion (Actual): April 30, 2024
• Study Completion (Estimated): April 30, 2025

Study Registration Dates

• First Submitted: April 25, 2022
• First Submitted That Met QC Criteria: April 25, 2022
• First Posted (Actual): April 28, 2022

Study Record Updates

• Last Update Posted (Actual): June 21, 2024
• Last Update Submitted That Met QC Criteria: June 19, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Musculoskeletal Diseases; Muscular Diseases; Tendon Injuries; Tendinopathy
• Other Study ID Numbers: WIRB CMEH 01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes