Treatment of Tendinosis Using the TenJet Hydroresection System

Last updated: June 19, 2024
Sponsor: Rothman Institute Orthopaedics
Overall Status: Active - Enrolling

Phase

N/A

Condition

Sprains

Tendon Injuries

Treatment

Hydrocision Tenjet System

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

Clinical Study ID

NCT05352139
WIRB CMEH 01
  • Ages 18-70
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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 studyprotocol

Exclusion

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-steroidalanti-inflammatory drug (NSAID) within 7 days of treatment

  • Steroid, PRP, Stem cell or biologic injections within 3 months of the studyprocedure date

  • Needle tenotomy, Tenex, or surgical interventions within 6 months of study proceduredate

  • Active local or systemic infection requiring antiviral, antibacterial or antifungaltreatment

  • Chronic conditions such as CRPS or fibromyalgia that might affect pain symptoms.

Study Design

Total Participants: 600
Treatment Group(s): 2
Primary Treatment: Hydrocision Tenjet System
Phase:
Study Start date:
May 01, 2022
Estimated Completion Date:
April 30, 2025

Connect with a study center

  • Standford Medicine

    Redwood City, California 94063
    United States

    Site Not Available

  • Cleveland Clinic

    Coral Springs, Florida 33067
    United States

    Site Not Available

  • Ochsner Health

    Baton Rouge, Louisiana 70836
    United States

    Site Not Available

  • University of North Carolina

    Chapel Hill, North Carolina 28223
    United States

    Site Not Available

  • Cleveland Clinic

    Lorain, Ohio 44053
    United States

    Site Not Available

  • Penn Highlands Orthopedics and Sports Medicine

    Clarion, Pennsylvania 16214
    United States

    Site Not Available

  • Rothman Orthopaedic Institute

    Philadelphia, Pennsylvania 19107
    United States

    Site Not Available

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