Genicular Artery Embolization for the Treatment of Moderate to Severe Osteoarthritic Knee Pain
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
- 1
- 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
研究组 & 干预措施
Genicular artery embolization
Participants will undergo the genicular artery embolization (GAE) procedure for the treatment of moderate to severe knee osteoarthritis. A total of 30 patients will be enrolled in the single treatment arm of the study.
The study will involve a screening period in which patient eligibility is determined. Once eligibility is confirmed, patients will undergo GAE with HydroPearl® Microspheres (polyethylene glycol microspheres, Terumo Medical, Somerset NJ). Following treatment, patients will undergo follow-up at 1, 6, 12, and 24 months post GAE.
干预措施: Genicular artery embolization (GAE) (Device)
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
Number of patients with treatment related adverse events
时间窗: 1 month post GAE
Adverse events will be evaluated for severity and graded following the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Number of patients with treatment related adverse events
时间窗: 6 months post GAE
Adverse events will be evaluated for severity and graded following the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Number of patients with treatment related adverse events
时间窗: 12 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)
- Mean change from baseline pain scores(Baseline to 1 month post GAE)
- Mean change from baseline pain scores(Baseline to 6 months post GAE)
- Mean change from baseline pain scores(Baseline to 12 months post GAE)
- Mean change from baseline knee function scores(Baseline to 1 month post GAE)
- Mean change from baseline knee function scores(Baseline to 6 months post GAE)
- Mean change from baseline knee function scores(Baseline to 12 months post GAE)
研究者
Andrew Picel
Assistant Clinical Professor
Stanford University