Clinical trial NCT03491397: Genicular Artery Embolization for the Treatment of Knee Osteoarthritis
Official title: Safety and Efficacy of Genicular Artery Embolization for the Treatment of Symptomatic Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Degenerative Joint Disease of Knee
Keywords: Microspheres
Artery Embolization
Knee Osteoarthritis
Chronic Pain
Embozene
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: Boston Scientific Corporation
First posted: 2018-04-09
Enrollment: 40
Sex: ALL
Minimum age (years): 40
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The stratification will not be randomized, but each category will be limited to 20 patients.
Primary purpose: TREATMENT

Brief summary: The purpose of this clinical research study is to examine whether Embozene treatment of the genicular artery is a safe and effective way to treat arthritic knee pain. Embozene is a medical device made by Boston Scientific approved in the United States for the treatment of hypervascular tumors and arteriovenous malformations. It consists of thousands of microscopic spheres that are injected into the artery in the knee going to the region of pain. One of the causes of pain in the setting of knee arthritis is increased blood flow going to the specific area of pain. The goal of this procedure is to decrease the blood flow (embolize) to the specific region of the knee that is causing your pain. This is done by infusing Embozene particles into the specific blood vessel (genicular artery) supplying the area of pain in the knee.

Detailed description: This is a phase 2, single-center, prospective, single arm investigational study to evaluate the safety and efficacy of genicular artery embolization (GAE) for treatment of symptomatic knee osteoarthritis (OA). Subjects will be treated with a genicular artery embolization (GAE) procedure performed with Embozene Microspheres. The microspheres will be delivered in a saline-contrast medium solution and will be delivered to the arteries supplying the areas of the subject's pain. The primary objective of this investigation is to assess safety of genicular artery embolization (GAE) for knee osteoarthritis (OA) using Embozene particles.

Eligibility criteria: Inclusion Criteria:

* Provided informed consent
* Age ≥ 40 years and ≤ 80 years
* Life expectancy greater than 12 months
* Ineligibility for or refusal of surgical management
* Moderate-severe knee pain as determined by visual analog scale \> 4
* Osteoarthritis based on xray
* Local knee tenderness
* Resistant/failed conservative treatment (e.g. NSAIDS/physical therapy/steroid joint injection)

Exclusion Criteria:• Mild knee pain as determined by visual analog scale \< 4

* Chronic renal insufficiency (serum creatinine \>2 mg/dL)
* Uncorrectable bleeding diathesis: international normalized ratio (INR) \>1.6, Platelets \<50,000
* Significant arterial atherosclerosis that would limit selective angiography
* Allergy to iodinated contrast agents that is not responsive to steroid management
* Active Infection or malignancy
* Appropriate candidate for knee replacement surgery determined by clinical and physical examination
* Recent (within 3 months) or active cigarette use

Primary outcomes:
measure: Number of Participants Experiencing Treatment-related Adverse Events, as a Measure of Safety
timeFrame: Up to 12 Months after GAE
Secondary outcomes:
measure: Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) as a Measure of Efficacy
timeFrame: Baseline, Month 1, Month 3, Month 6, Month 12
measure: Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Pain Subscale as a Measure of Efficacy
timeFrame: Baseline, Month 1, Month 3, Month 6, Month 12
measure: Change From Baseline in Visual Analog Scale (VAS) as a Measure of Efficacy
timeFrame: Baseline, Month 1, Month 3, Month 6, Month 12
Other outcomes:
Locations:
city: Santa Monica
country: United States
facility: Siddharth Padia, M.D.
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Siddharth Padia, M.D.
role: PRINCIPAL_INVESTIGATOR
References: