NCT07736248尚未招募不适用
Super Selective Angiographic Catheterization and Embolization of Genicular Arteries for Treatment of Symptomatic Knee Osteoarthritis
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 主要终点
- change from baseline in visual analog scale (VAS) pain score
研究概览
简要总结
To evaluate the efficacy and safety of genicular artery embolization in patients with symptomatic knee osteoarthritis refractory to conservative treatment.
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 70 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of knee osteoarthritis according to the criteria of the American College of Rheumatology.
- •Radiographic evidence of osteoarthritis corresponding to Kellgren-Lawrence grades I-III.
- •Moderate to severe knee pain for at least 6 months. Visual Analog Scale (VAS) score ≥
- •Failure of conservative treatment for at least 3 months including analgesics, non-steroidal anti-inflammatory drugs, physiotherapy, lifestyle modification, or intra-articular injections.
排除标准
- •Kellgren-Lawrence grade IV osteoarthritis.
- •Previous knee arthroplasty.
- •Inflammatory arthropathies such as rheumatoid arthritis, psoriatic arthritis, or gout.
- •Active local or systemic infection.
- •Severe peripheral arterial disease.
- •Coagulation disorders.
- •Renal insufficiency (raised renal chemistry).
- •Known allergy to iodinated contrast media.
- •Refuse to provide written informed consent
结局指标
主要结局
change from baseline in visual analog scale (VAS) pain score
时间窗: Baseline and 6 months after the Procedure
pain intensity measured using the 10-cm visual analog scale (VAS). scores range from 0 to 10, with higher scores indicating greater pain. The change from baseline to 6 months after genicular artery embolization will be assessed.
次要结局
- Technical Success Rate of Genicular Artery Embolization(During the procedure)
- Change from Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Total Score(Baseline, 3 months, and 6 months after the procedure)
- Change from Baseline in Health-Related Quality of Life Score (EQ-5D-5L)(Baseline and 6 months after the procedure)
研究者
Rehab Awad Mohamed Ahmed
principal investigator
Assiut University
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