Treatment of Tendinosis Using the TenJet Hydroresection System

Tendinopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05352139
• Other study ID #: WIRB CMEH 01
• Status: Enrolling by invitation
• Start date: May 1, 2022
• Est. completion date: April 30, 2024

Study information

• Verified date: April 2023
• Source: Rothman Institute Orthopaedics
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 600
• Est. completion date: April 30, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Tendinopathy
• Tendinosis

Intervention

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

Locations

Country	Name	City	State
United States	Ochsner Health	Baton Rouge	Louisiana
United States	University of North Carolina	Chapel Hill	North Carolina
United States	Rothman Orthopaedic Institute	Philadelphia	Pennsylvania
United States	Standford Medicine	Redwood City	California

Sponsors (1)

Lead Sponsor	Collaborator
Rothman Institute Orthopaedics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain reduction	Using the Visual Analog Scale for Pain (VAS) participants will be asked to report their pain score after surgery	2 years
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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