Percutaneous US Guided Elbow Tenotomy With the TenJet HydroSurgery System

NCT03487250 | Completed Results FDA Device

• 1 other identifier: PUGET-01-016
• Study Type: observational
• Target: 29
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Elbow, Tennis

Outcome Measures

Primary Outcomes (1)

• Change in Elbow Pain Using Visual Analog Scale (VAS)

  Change in elbow pain (VAS) compared with baseline. VAS range 0 (no pain) to 10 (intolerable pain); higher scores indicate worse pain. Mean change is calculated as baseline minus follow-up, so positive values indicate improvement. Time points: 2 weeks, 6 weeks, 3 months, 6 months, 12 months.

  Up to 12 months

Secondary Outcomes (1)

• Change in Elbow Function Using the Patient-Rated Elbow Evaluation Questionnaire (PREE)

  Up to 12 months

Study Arms (1)

TenJet System

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

Device: TenJet System

Interventions

TenJet System DEVICE

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

TenJet System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• HydroCision, Inc.: lead

Study Sites (3)

Orthopaedic Associates of Muskegon

Muskegon, Michigan, 49444, United States

Location

Penn Highlands

DuBois, Pennsylvania, 15801, United States

Location

Noble Pain Management & Sports Medicine

Fort Worth, Texas, 76110, United States

Location

MeSH Terms

Conditions

Tennis Elbow

Condition Hierarchy (Ancestors)

Elbow Tendinopathy; Tendinopathy; Muscular Diseases; Musculoskeletal Diseases; Elbow Injuries; Arm Injuries; Wounds and Injuries; Tendon Injuries

Results Point of Contact

• Title: Suneela Frary
• Organization: HydroCision

sfrary@hydrocision.com

978-289-1311

Study Officials

• Reginald Kapteyn, DO

  Orthopaedic Associates of Muskegon

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2018
• First Posted: April 3, 2018
• Study Start: August 4, 2016
• Primary Completion: April 20, 2019
• Study Completion: April 20, 2019
• Last Updated: May 7, 2026
• Results First Posted: May 7, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)