Prospective, Single Arm Investigation to Assess Effectiveness and Safety of Embosphere Microspheres for Embolization of the Geniculate Artery for the Treatment of Pain With Known Moderate to Severe Knee Osteoarthritis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- Change in knee pain as assessed by the WOMAC
研究概览
简要总结
The purpose of this research study is to evaluate the effectiveness and safety of a permanent embolic (Embosphere Microspheres) for embolization of the geniculate artery for the treatment of moderate to severe knee osteoarthritis.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject has signed informed consent
- •Subject is age 40-80
- •Subject is able to have an MRI
- •Minimum of prior 12 weeks of failed response to conservative therapy for knee osteoarthritis, which may include one or more of:
- •a) Oral or topical NSAIDS, opioid medications, intra-articular injection of glucocorticoids or hyaluronic acid, physical therapy.
- •Localized tenderness in anterior knee area
- •Kellgren-Lawrence grade 1, 2, or 3 as assessed by weight-bearing knee radiographs
- •Synovitis present as assessed by WORMS
- •VAS >50 mm
- •WOMAC score >30
排除标准
- •Rheumatoid arthritis
- •Local infection of the target knee(s)
- •Kellgren-Lawrence grade >3
- •Osteonecrosis evident by MRI
- •Prior knee arthroplasty
- •Allergy to iodinated contrast agents that cannot be managed by prophylaxis
- •Hypersensitivity to gelatin products
- •Any known condition that limits catheter-based intervention or is a contraindication to embolization
- •Active malignancy other than non-melanomatous skin cancer
- •Subject is pregnant, breastfeeding, or pre-menopausal and intending to become pregnant
- •Any other condition related to the subject's health and wellbeing deemed exclusionary in the opinion of the investigator
研究组 & 干预措施
Embosphere Microspheres group
Participants in this group who are receiving standard of care (SOC) embolization surgery for the treatment of moderate to severe knee osteoarthritis will receive the Embospheres Microspheres during scheduled SOC surgery.
干预措施: Embosphere Microspheres (Device)
结局指标
主要结局
Change in knee pain as assessed by the WOMAC
时间窗: Baseline, 24 Weeks (Post Embolization Surgery)
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain index assesses participants' pain on a scale ranging from 0 (none) to 4 (extreme). The pain subscale consists of 5 items and total scores can range from 0-20, with larger scores indicating greater pain.
Incidence of treatment related adverse events
时间窗: Up to 4 weeks (Post Embolization Surgery)
Procedure-related and target knee osteoarthritis-related adverse events as assessed by treating physician
次要结局
- Change in knee pain as assessed by VAS(Baseline, up to 52 weeks (Post Embolization Surgery))
- WORMS Score for Synovitis(Baseline, up to 52 weeks (Post Embolization Surgery))
- Kellgren-Lawrence Grade(Baseline, up to 52 weeks (Post Embolization Surgery))
- Change in knee pain(Baseline, up to 52 weeks (Post Embolization Surgery))
- Incidence of adverse events(Up to 52 weeks (Post Embolization Surgery))
研究者
Felipe Ferreira De Souza
Assistant Professor of Clinical Radiology
University of Miami