Status:
COMPLETED
Percutaneous US Guided Elbow Tenotomy With the TenJet HydroSurgery System
Lead Sponsor:
HydroCision, Inc.
Conditions:
Elbow, Tennis
Eligibility:
All Genders
18+ years
Brief Summary
To evaluate the acute and long-term clinical outcomes of tenotomy with the TenJet System in patients with elbow tendinosis.
Detailed Description
This is a prospective, non-randomized, single arm post-marketing clinical study of patients undergoing percutaneous ultrasound guided medial and lateral tenotomy using the TenJet HydroSurgery System t...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 4 2016
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 20 2019
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT03487250
Start Date
August 4 2016
End Date
April 20 2019
Last Update
April 30 2019
Active Locations (3)
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1
Orthopaedic Associates of Muskegon
Muskegon, Michigan, United States, 49444
2
Penn Highlands
DuBois, Pennsylvania, United States, 15801
3
Noble Pain Management & Sports Medicine
Fort Worth, Texas, United States, 76110