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ENROLLING BY INVITATION
NCT05352139

Treatment of Tendinosis Using the TenJet Hydroresection System

Sponsor: Rothman Institute Orthopaedics

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

OBSERVATIONAL

Enrollment

600

Start Date

2022-05-01

Completion Date

2025-04-30

Last Updated

2024-06-21

Healthy Volunteers

Yes

Interventions

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 (7)

Standford Medicine

Redwood City, California, United States

Cleveland Clinic

Coral Springs, Florida, United States

Ochsner Health

Baton Rouge, Louisiana, United States

University of North Carolina

Chapel Hill, North Carolina, United States

Cleveland Clinic

Lorain, Ohio, United States

Penn Highlands Orthopedics and Sports Medicine

Clarion, Pennsylvania, United States

Rothman Orthopaedic Institute

Philadelphia, Pennsylvania, United States