Genicular Artery Embolization for the Treatment of Knee Osteoarthritis
CompletedNot applicableNCT03491397
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- Safety and Efficacy of Genicular Artery Embolization for the Treatment of Symptomatic Knee Osteoarthritis
- Conditions
- Knee Osteoarthritis
- Degenerative Joint Disease of Knee
- Interventions
- Device: Embozene MicroSpheres
- Sponsor
- Siddharth Padia, MD
- Collaborators
- Boston Scientific Corporation
- Organization
- University of California, Los Angeles
- Start date
- 2019-02-10
- Primary completion
- 2021-10-29
- Sex
- All
- Age range
- from 40 Years to 79 Years
- Results posted
- Yes, on ClinicalTrials.gov
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT03491397