Percutaneous US Guided Elbow Tenotomy With the TenJet HydroSurgery System

Completed

• Conditions: Elbow, Tennis
• Interventions: Device: TenJet System

• Registration Number: NCT03487250
• Lead Sponsor: HydroCision, Inc.

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 to treat elbow tendinosis. Patients will be followed for a maximum of 12 months post-procedure.

Study Timeline

• Study Start: 2016-08-04
• Study First Submitted: 2018-03-25
• Study First Submitted QC: 2018-03-25
• Study First Posted: 2018-04-03
• Status Verified: 2019-04
• Primary Completion: 2019-04-20
• Study Completion: 2019-04-20
• Last Update Submitted: 2019-04-28
• Last Update Posted: 2019-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
TenJet System	TenJet System	Percutaneous ultrasound guided medial and lateral tenotomy using the TenJet HydroSurgery System

Primary Outcome Measures

Name	Time	Method
Change in elbow pain using Visual Analog Scale (VAS)	Up to 12 months	Change in elbow pain VAS compared to baseline

Secondary Outcome Measures

Name	Time	Method
Pain medication usage	Up to 12 months	Reduction in medications for elbow pain
Change in Elbow Function using the Patient-Rated Elbow Evaluation Questionnaire (PREE)	Up to 12 months	Change in PREE compared to baseline

Trial Locations

Locations (3)

Orthopaedic Associates of Muskegon; 🇺🇸 Muskegon, Michigan, United States

Noble Pain Management & Sports Medicine; 🇺🇸 Fort Worth, Texas, United States

Penn Highlands; 🇺🇸 DuBois, Pennsylvania, United States