N/A
N=40
Genicular Artery Embolization for the Treatment of Knee Osteoarthritis
Knee Osteoarthritis · Degenerative Joint Disease of Knee
Bottom Line
View on ClinicalTrials.gov: NCT03491397 ↗Enrolled (actual)
40
Serious AEs
2.5%
Results posted
Nov 2022
Primary outcome: Primary: Number of Participants Experiencing Treatment-related Adverse Events, as a Measure of Safety — 1; 7; 2 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Embozene MicroSpheres (Device)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- Siddharth Padia, MD
- Primary completion
- Oct 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Experiencing Treatment-related Adverse Events, as a Measure of Safety |
1; 7; 2 | — |
| SECONDARY Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) as a Measure of Efficacy |
-20.5; -29.5; -26.5; -29.0 | — |
| SECONDARY Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Pain Subscale as a Measure of Efficacy |
-6; -7; -7; -7.5 | — |
| SECONDARY Change From Baseline in Visual Analog Scale (VAS) as a Measure of Efficacy |
-4.5; -4.5; -5.0; -5.0 | — |
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.
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 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
Data sourced from ClinicalTrials.gov (NCT03491397). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.