Pilot Study: Geniculate Artery Embolization in Knee Osteoarthrosis.
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Pain control VAS
研究概览
简要总结
Geniculate Artery Embolization (GAE) has recently been described and studied as a palliative treatment for osteoarthrosis-related knee pain in patients un-eligible for surgical intervention. This treatment is based on the hypothesis that hypervascularization and associated increased nerve proliferation are possible sources of chronic pain following the morphological changes of osteoarthrosis. A large animal model has shown digital subtraction arteriography to be well correlated to both the histological findings of synovial inflammation and synovial contrast enhancement on magnetic resonance imaging. This embolization technique has also been applied to other regions of the musculoskeletal system including the elbow and the shoulder.
详细描述
Primary Objective Confirm the efficacy and the effectiveness of geniculate artery embolization for pain control in knee osteoarthrosis.
Secondary Objective Evaluate the effectiveness of geniculate artery embolization for pain control in specific population: young patients between 18 and 50 years old with advanced osteoarthritis (KL grade 3 or 4) for whom an orthopedic surgeon has deemed a total knee arthroplasty is not an appropriate therapy, and whom have failed conservative management for at least 6 months.
Investigators propose a prospective pilot study on 40 patients with osteoarthrosis.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years and older
- •Moderate to severe knee pain (visual analog scale (VAS) > 70 mm)
- •Pain refractory to at least 6 months of conservative therapies (anti-inflammatory drugs, or physical therapy, or muscle strengthening, or intra-articular injections)
- •Localized pain on physical examination
- •Kellgren-Lawrence (KL) Score on knee X-Ray
- •Patients 50 years old and over : grade 1, 2, 3 or 4
- •18-50 years old: KL grade 3 or 4
排除标准
- •Current local infection
- •Life expectancy less than 6 months
- •Known advanced atherosclerosis
- •Rheumatoid or infectious arthritis
- •Prior knee surgery
- •Uncorrectable coagulopathy including international normalized ratio (INR) > 1.5 or platelets < 50,000
- •Iodine allergy
- •Renal dysfunction as defined by GFR < 60ml/min obtained within the past 30 days.
- •Diabetic patient
- •Previous embolization of the geniculate arteries during the last year
结局指标
主要结局
Pain control VAS
时间窗: 12 months
The pain intensity is assessed using VAS (horizontal line 100 mm in length). Subjects mark the VAS with a single vertical line to indicate their current pain level, with 0 mm representing "No Pain" and 100 mm representing "Worst Possible Pain". * Expected mean VAS pre treatment: 7 * Expected mean VAS at 1, 3, 6 and 12 months: 3-4 (50% reduction)
次要结局
- Radiological examinations(12 months)
- Function(12 months)
研究者
Alexandre Cengarle-Samak
Interventional radiologist
Maisonneuve-Rosemont Hospital