Creation Of a Prospective Registry For Genicular Artery Embolization At The Joint & Vascular Institute
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,200
- 试验地点
- 1
- 主要终点
- Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
研究概览
简要总结
The goal of this observational study (prospective registry) is to collect long-term real-world data on the effectiveness and safety of genicular artery embolization (GAE) for knee osteoarthritis in adults aged 18 years or older with symptomatic KOA that has not responded to medical therapy.
The main questions it aims to answer are:
- Does GAE lead to sustained improvement in pain (WOMAC, VAS) and quality-of-life scores over 12-36 months?
- What patient or procedural factors are associated with better outcomes after GAE?
Participants will:
- Undergo GAE as part of their routine clinical care.
- Complete clinical follow-up assessments at 1, 3, 6, 12, 18, 24, and 36 months after treatment, including symptom and quality-of-life questionnaires.
- Have safety outcomes tracked according to Society of Interventional Radiology guidelines.
There is no comparison group; results will be analyzed to identify predictors of success and inform best practices for patient selection and treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Adults (≥18 years) with symptomatic KOA refractory to medical therapy, referred for GAE.
排除标准
- •Pregnancy, coagulopathy, severe comorbidities, or inability to consent.
结局指标
主要结局
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
时间窗: 5 years of enrollment/patient
The investigators will describe differences in pain response with Genicular Artery Embolization (GAE) compared to a sham procedure when treating medically refractory mild to moderate Knee Osteoarthritis (KOA) at 12 months as measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain subscale score. A higher score index a higher pain level while a lower score indicates lower pain levels. The score range is 0 to 96.
次要结局
未报告次要终点