NCT04472091撤回不适用
Genicular Artery Embolization for the Treatment of Moderate to Severe Osteoarthritic Knee Pain
Andrew Picel2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年1月15日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Number of patients with treatment related adverse events
研究概览
简要总结
The objective of this investigation is to evaluate the safety of the geniculate artery embolization (GAE) procedure with HydroPearl® Microspheres in 30 patients with knee pain caused by osteoarthritis with 24 months follow-up. The GAE procedure is an arterial embolization procedure that blocks abnormal blood vessels caused be knee arthritis in order to evaluate the effect on knee pain.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provide informed consent
- •Age ≥ 40 years
- •Moderate to severe knee pain (VAS >40 mm)
- •Pain refractory to 3 months of conservative treatments, including at least one of the following:
- •a. Anti-inflammatory medications
- •b. Physical therapy
- •c. Intra-articular injections
- •Kellgren-Lawrence radiographic grade 1, 2, or 3 disease
- •MRI features of active synovitis (synovial thickening and/or enhancement on MRI).
- •Ineligibility or refusal of surgical management.
- •Local knee tenderness
排除标准
- •Rheumatoid or infectious arthritis
- •Advanced lower extremity atherosclerosis that would limit selective angiography
- •Local knee infection
- •Prior knee surgery (excluding arthroscopic/meniscal interventions)
- •Uncorrectable coagulopathy (INR>1.8, platelets<50,000/µL)
- •Iodine allergy resulting in anaphylaxis
- •Chronic renal insufficiency (serum creatinine >2 mg/dL)
- •Life expectancy less than 6 months
结局指标
主要结局
Number of patients with treatment related adverse events
时间窗: 24 months post GAE
Adverse events will be evaluated for severity and graded following the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
次要结局
- Mean change from baseline pain scores(Baseline 24 months post GAE)
- Mean change from baseline knee function scores(Baseline to 24 months post GAE)
研究者
Andrew Picel
Assistant Clinical Professor
Stanford University
研究点 (2)
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