Percutaneous US Guided Elbow Tenotomy With the TenJet HydroSurgery System (NCT03487250) | Clinical Trial Compass
CompletedNot Applicable
Percutaneous US Guided Elbow Tenotomy With the TenJet HydroSurgery System
United States29 participantsStarted 2016-08-04
Plain-language summary
To evaluate the acute and long-term clinical outcomes of tenotomy with the TenJet System in patients with elbow tendinosis.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patient is \> 18 years of age
* Chronic lateral or medial elbow pain \> 3 month duration
* History and clinical examination consistent with lateral or medial epicondylitis
* Sonographic evidence of medial or lateral elbow tendinosis as evidenced by
* tendon thickening and hypoechogenicity,
* with or without hypervascularity on Doppler examination and,
* with or without cortical irregularities, Or MRI findings consistent with lateral or medial tendinosis, with or without intrasubstance tear.
* \> 3 months of non-operative treatment that included
* nonsteroidal anti-inflammatory drugs
* activity modification
* physical therapy
* elbow straps
* With or without previous steroid injections, protein rich plasma injections, or stem cell injections
* Patient is willing and able to provide informed consent and comply with the study protocol
Exclusion Criteria:
* Documented ipsilateral upper extremity musculoskeletal condition (other than elbow tendinosis in the same arm on the opposite side)
* Bleeding disorders and/or current use of anti-coagulants with the inability to withhold anticoagulants for required time prior to procedure
* Use of acetylsalicylic acid (ASA) and/or non-steroidal anti-inflammatory drug (NSAID) within 7 days of treatment
* Steroid injection within 4 weeks of the study procedure
* Active local or systemic infection
* Patient found to have further degenerative changes of the elbow contributing to pain, such as cartilage t…
What they're measuring
1
Change in Elbow Pain Using Visual Analog Scale (VAS)