Treatment of Tendinosis Using the TenJet Hydroresection System
NCT ID: NCT05352139
Last Updated: 2024-06-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
600 participants
OBSERVATIONAL
2022-05-01
2025-04-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Elbow Tendinosis (Epicondylitis)
Treatment of participants who present with either lateral or medial epicondylitis
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.
Hydrocision Tenjet System
The TenJet system will be used during surgery to remove the damaged tissue from the joint
Hip Tendinosis (Gluteal Tendinopathy)
Treatment of participants diagnosed with Recalcitrant Gluteal Tendinopathy
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.
Hydrocision Tenjet System
The TenJet system will be used during surgery to remove the damaged tissue from the joint
Shoulder Calcific Tendinosis (Calcific Shoulder Tendinopathy)
Treatment of participants diagnosed with Calcific Shoulder Tendinopathy
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.
Hydrocision Tenjet System
The TenJet system will be used during surgery to remove the damaged tissue from the joint
Interventions
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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.
Hydrocision Tenjet System
The TenJet system will be used during surgery to remove the damaged tissue from the joint
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
70 Years
ALL
Yes
Sponsors
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Rothman Institute Orthopaedics
OTHER
Responsible Party
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Locations
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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
Countries
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Other Identifiers
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WIRB CMEH 01
Identifier Type: -
Identifier Source: org_study_id
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