N/A
N=29
Percutaneous US Guided Elbow Tenotomy With the TenJet HydroSurgery System
Elbow, Tennis
Bottom Line
View on ClinicalTrials.gov: NCT03487250 ↗Enrolled (actual)
29
Serious AEs
0.0%
Results posted
May 2026
Primary outcome: Primary: Change in Elbow Pain Using Visual Analog Scale (VAS) — 5.1; 3.0; 1.9; 1.1 VAS Score
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- TenJet System (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- HydroCision, Inc.
- Primary completion
- Apr 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Elbow Pain Using Visual Analog Scale (VAS) |
5.1; 3.0; 1.9; 1.1; 0.7; 0.5 | — |
| SECONDARY Change in Elbow Function Using the Patient-Rated Elbow Evaluation Questionnaire (PREE) |
58.5; 37.9; 25.2; 18.1; 14.0; 9.6 | — |
Summary
To evaluate the acute and long-term clinical outcomes of tenotomy with the TenJet System in patients with elbow tendinosis.
Eligibility Criteria
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 thinning, loose body, or evidence of tendinosis other than medial or lateral, including triceps or ulnar collateral ligament.
- Patient is known or suspected to be pregnant
Data sourced from ClinicalTrials.gov (NCT03487250). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.