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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Elbow Tendinosis (Epicondylitis) | Treatment of participants who present with either lateral or medial epicondylitis |
| |
| Hip Tendinosis (Gluteal Tendinopathy) | Treatment of participants diagnosed with Recalcitrant Gluteal Tendinopathy |
| |
| Shoulder Calcific Tendinosis (Calcific Shoulder Tendinopathy) | Treatment of participants diagnosed with Calcific Shoulder Tendinopathy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain reduction | Using the Visual Analog Scale for Pain (VAS) participants will be asked to report their pain score after surgery | 2 years |
| Return to function (Elbow #1) | This will be measured in participants undergoing treatment for Elbow Tendinopathy using the Mayo Elbow Performance Score (MEPS) | 2 years |
| Return to function (Elbow #2) | This will be measured in participants undergoing treatment for Elbow Tendinopathy using the Patient-Rated Tennis Elbow Evaluation (PRTEE) survey | 2 years |
| Return to function (Elbow #3) | This will be measured in participants undergoing treatment for Elbow Tendinopathy using the Quick Disability Arm, Shoulder and Hand (QDASH) survey | 2 years |
| Return to function (All cohorts) | This will be measured in participants undergoing treatment for Elbow, Hip and Shoulder Tendinopathy using the Short Form Health Survey (SF-12) survey | 2 years |
| Return to Function (Hip) | This will be measured in participants undergoing treatment for Hip Tendinopathy using the Victorian Institute of Sport Assessment-Gluteal Questionnaire (VISA-G) survey | 2 years |
| Return to Function (Shoulder) | This will be measured in participants undergoing treatment for Shoulder Tendinopathy using the American Shoulder & Elbow Score (ASES) survey |
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Inclusion Criteria:
Exclusion Criteria:
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Patients between 18-70 years old presenting with chronic, refractory lateral and medial elbow, hip, or shoulder pain, secondary to tendinosis.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Standford Medicine | Redwood City | California | 94063 | United States | ||
| Cleveland Clinic |
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| Hydrocision Tenjet System | Device | The TenJet system will be used during surgery to remove the damaged tissue from the joint |
|
| 2 years |
| Coral Springs |
| Florida |
| 33067 |
| United States |
| Ochsner Health | Baton Rouge | Louisiana | 70836 | United States |
| University of North Carolina | Chapel Hill | North Carolina | 28223 | United States |
| Cleveland Clinic | Lorain | Ohio | 44053 | United States |
| Penn Highlands Orthopedics and Sports Medicine | Clarion | Pennsylvania | 16214 | United States |
| Rothman Orthopaedic Institute | Philadelphia | Pennsylvania | 19107 | United States |
| ID | Term |
|---|---|
| D052256 | Tendinopathy |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D013708 | Tendon Injuries |
| D014947 | Wounds and Injuries |
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