Clinical trial NCT03487250: Percutaneous US Guided Elbow Tenotomy With the TenJet HydroSurgery System
Official title: Prospective Multi-Center Evaluation of Percutaneous Ultrasound Guided Elbow Tenotomy (PUGET) Using the HydroCision TenJet HydroSurgery System
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Elbow, Tennis
Lead sponsor: HydroCision, Inc.
Sponsor class: INDUSTRY
First posted: 2018-04-03
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with chronic, refractory lateral or medial elbow pain secondary to elbow tendinosis

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

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.

Eligibility 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

Primary outcomes:
measure: Change in elbow pain using Visual Analog Scale (VAS)
timeFrame: Up to 12 months
Secondary outcomes:
measure: Change in Elbow Function using the Patient-Rated Elbow Evaluation Questionnaire (PREE)
timeFrame: Up to 12 months
measure: Pain medication usage
timeFrame: Up to 12 months
Other outcomes:
Locations:
city: Muskegon
country: United States
facility: Orthopaedic Associates of Muskegon
state: Michigan
city: DuBois
country: United States
facility: Penn Highlands
state: Pennsylvania
city: Fort Worth
country: United States
facility: Noble Pain Management & Sports Medicine
state: Texas
Study officials:
affiliation: Orthopaedic Associates of Muskegon
name: Reginald Kapteyn, DO
role: PRINCIPAL_INVESTIGATOR
References: