Treatment of Tendinosis Using the TenJet Hydroresection System

Part of paid clinical trials in Redwood City, California.

Sponsor
Rothman Institute Orthopaedics
Study ID
NCT05352139
Status
Enrolling By Invitation

Conditions

  • Tendinopathy
  • Tendinosis

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Accepted

Interventions

  • Resection (removal) of the degenerative tissue using the Hydrocision TenJet system — PROCEDURE
    During the procedure, the TenJet device will remove degenerative tendinopathic tissue using pressurized saline without causing harm to the healthy tendon fibers.
  • Hydrocision Tenjet System — DEVICE
    The TenJet system will be used during surgery to remove the damaged tissue from the joint

Study Details

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.

Key Dates

Start date
May 1, 2022
Status verified
Jun 2024
Primary completion
Apr 30, 2024
Completion
Apr 30, 2025

Study Design

Enrollment
600 participants (estimated)

Arms

  • Arm: Elbow Tendinosis (Epicondylitis)
    Treatment of participants who present with either lateral or medial epicondylitis
  • Arm: Hip Tendinosis (Gluteal Tendinopathy)
    Treatment of participants diagnosed with Recalcitrant Gluteal Tendinopathy
  • Arm: Shoulder Calcific Tendinosis (Calcific Shoulder Tendinopathy)
    Treatment of participants diagnosed with Calcific Shoulder Tendinopathy

Primary Outcome Measure

Pain reduction [ Time Frame: 2 years ]

Locations (7)

FacilityCityStateZIPSite coordinators
Standford MedicineRedwood CityCalifornia94063-
Cleveland ClinicCoral SpringsFlorida33067-
Ochsner HealthBaton RougeLouisiana70836-
University of North CarolinaChapel HillNorth Carolina28223-
Cleveland ClinicLorainOhio44053-
Penn Highlands Orthopedics and Sports MedicineClarionPennsylvania16214-
Rothman Orthopaedic InstitutePhiladelphiaPennsylvania19107-

Find similar trials in Redwood City, CA

By research site
Standford Medicine· Redwood City, CACleveland Clinic· Coral Springs, FLOchsner Health· Baton Rouge, LAUniversity of North Carolina· Chapel Hill, NCCleveland Clinic· Lorain, OHPenn Highlands Orthopedics and Sports Medicine· Clarion, PA

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