Percutaneous US Guided Elbow Tenotomy With the TenJet HydroSurgery System

Elbow, Tennis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03487250
• Other study ID #: PUGET-01-016
• Status: Completed
• Start date: August 4, 2016
• Est. completion date: April 20, 2019

Study information

• Verified date: April 2019
• Source: HydroCision, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: April 20, 2019
• Est. primary completion date: April 20, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Elbow, Tennis
• Tennis Elbow

Intervention

Device:
• TenJet System
Percutaneous ultrasound guided medial and lateral tenotomy using the TenJet HydroSurgery System

Locations

Country	Name	City	State
United States	Penn Highlands	DuBois	Pennsylvania
United States	Noble Pain Management & Sports Medicine	Fort Worth	Texas
United States	Orthopaedic Associates of Muskegon	Muskegon	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
HydroCision, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in elbow pain using Visual Analog Scale (VAS)	Change in elbow pain VAS compared to baseline	Up to 12 months
Secondary	Change in Elbow Function using the Patient-Rated Elbow Evaluation Questionnaire (PREE)	Change in PREE compared to baseline	Up to 12 months
Secondary	Pain medication usage	Reduction in medications for elbow pain	Up to 12 months