Safety and Efficacy of Genicular Artery Embolization for the Treatment of Symptomatic Knee Osteoarthritis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Number of Participants Experiencing Treatment-related Adverse Events, as a Measure of Safety
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
结局指标
主要结局
Number of Participants Experiencing Treatment-related Adverse Events, as a Measure of Safety
时间窗: Up to 12 Months after GAE
Treatment-related AEs from gennicular artery embolization during the study period
次要结局
- Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) as a Measure of Efficacy(Baseline, Month 1, Month 3, Month 6, Month 12)
- Change From Baseline in Visual Analog Scale (VAS) as a Measure of Efficacy(Baseline, Month 1, Month 3, Month 6, Month 12)
- Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Pain Subscale as a Measure of Efficacy(Baseline, Month 1, Month 3, Month 6, Month 12)
研究者
Siddharth Padia, MD
Principal Investigator
University of California, Los Angeles