Percutaneous US Guided Elbow Tenotomy With the TenJet HydroSurgery System

Prospective Multi-Center Evaluation of Percutaneous Ultrasound Guided Elbow Tenotomy (PUGET) Using the HydroCision TenJet HydroSurgery System

To evaluate the acute and long-term clinical outcomes of tenotomy with the TenJet System in patients with elbow tendinosis.

Study Overview

• Status: Completed
• Conditions: Elbow, Tennis
• Intervention / Treatment: Device: TenJet System

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 Type: Observational
• Enrollment (Actual): 29

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Muskegon, Michigan, United States, 49444
      • Orthopaedic Associates of Muskegon
  • Pennsylvania
    • DuBois, Pennsylvania, United States, 15801
      • Penn Highlands
  • Texas
    • Fort Worth, Texas, United States, 76110
      • Noble Pain Management & Sports Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with chronic, refractory lateral or medial elbow pain secondary to elbow tendinosis

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
TenJet System; Percutaneous ultrasound guided medial and lateral tenotomy using the TenJet HydroSurgery System	Device: TenJet System; Percutaneous ultrasound guided medial and lateral tenotomy using the TenJet HydroSurgery System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in elbow pain using Visual Analog Scale (VAS)	Change in elbow pain VAS compared to baseline	Up to 12 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: HydroCision, Inc.
• Investigators: Principal Investigator: Reginald Kapteyn, DO, Orthopaedic Associates of Muskegon

Study record dates

Study Major Dates

• Study Start (Actual): August 4, 2016
• Primary Completion (Actual): April 20, 2019
• Study Completion (Actual): April 20, 2019

Study Registration Dates

• First Submitted: March 25, 2018
• First Submitted That Met QC Criteria: March 25, 2018
• First Posted (Actual): April 3, 2018

Study Record Updates

• Last Update Posted (Actual): April 30, 2019
• Last Update Submitted That Met QC Criteria: April 28, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Musculoskeletal Diseases; Muscular Diseases; Tendon Injuries; Tendinopathy; Arm Injuries; Elbow Tendinopathy; Tennis Elbow
• Other Study ID Numbers: PUGET-01-016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes