Treatment of Tendinosis Using the TenJet Hydroresection System

Rothman Institute Orthopaedics

Status

Invitation-only

Conditions

Tendinosis

Tendinopathy

Treatments

Device: Hydrocision Tenjet System

Procedure: Resection (removal) of the degenerative tissue using the Hydrocision TenJet system

Study type

Observational

Funder types

Other

Identifiers

NCT05352139

WIRB CMEH 01

Details and patient eligibility

About

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.

Enrollment

600 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

Accepts Healthy Volunteers

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.