Percutaneous US Guided Elbow Tenotomy With the TenJet HydroSurgery System

HydroCision

Status: Completed

Conditions: Elbow, Tennis

Treatments: Device: TenJet System

Study type: Observational

Funder types: Industry

Identifiers

NCT03487250

PUGET-01-016

Details and patient eligibility

About

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

Full 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.

Enrollment: 29 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

29 participants in 1 patient group

TenJet System

Description:

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

Treatment:

Device: TenJet System