NCT06134817终止不适用
Prospective Pilot Study on Geniculate Artery Embolization for Treatment of Persistent Knee Pain Post Total Knee Arthroplasty
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 2
- 主要终点
- Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain Score From Baseline to Month 6
研究概览
简要总结
Single-arm, single-center, no sham or placebo, prospective pilot trial designed to evaluate the safety and efficacy of transcatheter arterial embolization in patients with persistent knee pain resistant to conservative management for at least 9 months after total knee arthroplasty (TKA). Eligible participants will receive geniculate artery embolization (GAE) using Embozene™ Color-Advanced Microspheres. Patients will be followed up for a total of 24 months after GAE.
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
- 30 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Knee pain resistant to conservative treatment for at least 9 months post TKA performed for knee OA, and
- •Moderate to severe knee pain: pain VAS ≥40 mm, and
- •Willing, able, and mentally competent to provide informed consent and complete study questionnaires in English. The Study questionnaires are validated in English.
排除标准
- •Active systemic or local knee infection or;
- •Active malignancy or;
- •Life expectancy less than 6 months or;
- •Prior ipsilateral knee arthroscopic surgery or repeat TKA (within 9 months of screening) or;
- •Ipsilateral knee intra-articular injection in the last 3 months or;
- •Rheumatoid arthritis, spondyloarthropathies, crystal disease, gout, pseudogout, or lupus or;
- •Pregnant during the study period or;
- •Renal dysfunction as defined by serum creatinine >1.6 dl/mg or eGFR <60 on blood tests obtained within 30 days of procedure or;
- •Body weight greater than 200 Kg or;
- •Known history of severe contrast allergy to iodinated contrast resulting in anaphylaxis or;
- •Known significant arterial atherosclerosis that would limit selective angiography and/or lower extremity symptoms thought to be secondary to arterial vascular disease (eg claudication, ischemic rest pain) or;
- •known avascular necrosis in the target knee or;
- •Complications of TKA such as suspected or confirmed early loosening, ligamentous instability, reflex sympathetic dystrophy, polyethylene wear with or without particle disease (osteolysis), and large effusions (with or without hemarthrosis) or;
- •Patient is enrolled in a different trial for treatment of knee pain post total knee arthroplasty (ipsilateral knee)
结局指标
主要结局
Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain Score From Baseline to Month 6
时间窗: Baseline, Month 6 Post-GAE Procedure
The Pain subscale of the KOOS consists of 9 items measuring pain associated with the knee. Each item is rated on a Likert scale from 0 (No Problems) to 4 (Extreme Problems). The raw score is the sum of responses and is transformed to a 0-100 scale, where zero represents extreme knee problems and 100 represents no knee problems.
次要结局
- Incidence of Synovitis(Month 24 Post-GAE Procedure)
- Incidence of Successful Selective Catheterization of Target Genicular Artery(Up to Month 24 Post-GAE Procedure)
- Change From Baseline in Quality of Life Measured Via EuroQol-5 Dimension-5 Level (EQ-5D-5L) Score(Baseline, Month 3 Post-GAE Procedure)
- Change From Baseline in Quality of Life Measured Via EQ-5D-5L Score(Baseline, Month 24 Post-GAE Procedure)
- Incidence of Synovitis(Month 24 Post-GAE Procedure)
- Change From Baseline in KOOS Symptoms Score(Baseline, Month 24 Post-GAE Procedure)
- Change From Baseline in Knee Pain Measured Via Visual Analogue Scale (VAS)(Baseline, Month 3 Post-GAE Procedure)
- Change From Baseline in Knee Pain Measured Via VAS(Baseline, Month 24 Post-GAE Procedure)
- Incidence of Successful Selective Catheterization of Target Genicular Artery(Up to Month 24 Post-GAE Procedure)
- Incidence of Successful Embolization From at Least One Feeding Artery of the Knee Joint(Up to Month 24 Post-GAE Procedure)
研究者
研究点 (2)
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