Tendinopathy, Tendinosis
Conditions
Brief 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.
Interventions
PROCEDUREResection (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.
DEVICEHydrocision Tenjet System
The TenJet system will be used during surgery to remove the damaged tissue from the joint
Sponsors
Rothman Institute Orthopaedics
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain reduction | 2 years | Using the Visual Analog Scale for Pain (VAS) participants will be asked to report their pain score after surgery |
| Return to function (Elbow #1) | 2 years | This will be measured in participants undergoing treatment for Elbow Tendinopathy using the Mayo Elbow Performance Score (MEPS) |
| Return to function (Elbow #2) | 2 years | This will be measured in participants undergoing treatment for Elbow Tendinopathy using the Patient-Rated Tennis Elbow Evaluation (PRTEE) survey |
| Return to function (Elbow #3) | 2 years | This will be measured in participants undergoing treatment for Elbow Tendinopathy using the Quick Disability Arm, Shoulder and Hand (QDASH) survey |
| Return to function (All cohorts) | 2 years | This will be measured in participants undergoing treatment for Elbow, Hip and Shoulder Tendinopathy using the Short Form Health Survey (SF-12) survey |
| Return to Function (Hip) | 2 years | This will be measured in participants undergoing treatment for Hip Tendinopathy using the Victorian Institute of Sport Assessment-Gluteal Questionnaire (VISA-G) survey |
| Return to Function (Shoulder) | 2 years | This will be measured in participants undergoing treatment for Shoulder Tendinopathy using the American Shoulder & Elbow Score (ASES) survey |
Countries
United States
Outcome results
None listed