NCT05352139

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

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 600 (estimated)
• Sponsor: Rothman Institute Orthopaedics · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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.

Conditions

• Tendinopathy
• Tendinosis

Interventions

Type	Name	Description
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

Timeline

• Start date: 2022-05-01
• Primary completion: 2024-04-30
• Completion: 2025-04-30
• First posted: 2022-04-28
• Last updated: 2024-06-21

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated device study