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Percutaneous US Guided Elbow Tenotomy With the TenJet HydroSurgery System

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03487250
Recruitment Status : Completed
First Posted : April 3, 2018
Last Update Posted : April 30, 2019
Sponsor:
Information provided by (Responsible Party):
HydroCision, Inc.

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

Condition or disease Intervention/treatment
Elbow, Tennis 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.

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Study Type : Observational
Actual Enrollment : 29 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Multi-Center Evaluation of Percutaneous Ultrasound Guided Elbow Tenotomy (PUGET) Using the HydroCision TenJet HydroSurgery System
Actual Study Start Date : August 4, 2016
Actual Primary Completion Date : April 20, 2019
Actual Study Completion Date : April 20, 2019

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




Primary Outcome Measures :
  1. Change in elbow pain using Visual Analog Scale (VAS) [ Time Frame: Up to 12 months ]
    Change in elbow pain VAS compared to baseline


Secondary Outcome Measures :
  1. Change in Elbow Function using the Patient-Rated Elbow Evaluation Questionnaire (PREE) [ Time Frame: Up to 12 months ]
    Change in PREE compared to baseline

  2. Pain medication usage [ Time Frame: Up to 12 months ]
    Reduction in medications for elbow pain



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with chronic, refractory lateral or medial elbow pain secondary to elbow tendinosis
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03487250


Locations
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United States, Michigan
Orthopaedic Associates of Muskegon
Muskegon, Michigan, United States, 49444
United States, Pennsylvania
Penn Highlands
DuBois, Pennsylvania, United States, 15801
United States, Texas
Noble Pain Management & Sports Medicine
Fort Worth, Texas, United States, 76110
Sponsors and Collaborators
HydroCision, Inc.
Investigators
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Principal Investigator: Reginald Kapteyn, DO Orthopaedic Associates of Muskegon
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Responsible Party: HydroCision, Inc.
ClinicalTrials.gov Identifier: NCT03487250    
Other Study ID Numbers: PUGET-01-016
First Posted: April 3, 2018    Key Record Dates
Last Update Posted: April 30, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Tennis Elbow
Elbow Tendinopathy
Tendinopathy
Muscular Diseases
Musculoskeletal Diseases
Arm Injuries
Wounds and Injuries
Tendon Injuries