Novel Transcatheter Arterial Embolization for Treatment of Knee Osteoarthritis: a Randomized Sham-controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 2
- 主要终点
- KOOS pain sub score
研究概览
简要总结
In this double blind randomized sham controlled study the investigators want to establish the efficacy of transcatheter arterial embolization of neovessels for patients with symptomatic mild to moderate knee osteoarthritis after 4 months compared to a sham-embolization.
详细描述
Rationale:
Transcatheter arterial embolization has recently been proposed as an efficacious therapy for therapy-resistant osteoarthritis of the knee, providing substantial pain reduction at short-term as well as long-term follow-up up till 4 years.
A potential working mechanism of treatment effect is that the normalization of the amount of blood vessels and blood flow achieved by embolization reduces inflammation, resulting in pain reduction
Objective:
The main objective is to assess whether transcatheter arterial embolization of neovessels in patients with symptomatic knee OA results in significant pain reduction after 4 months compared to sham treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
Double blinded
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
- •Age.≥18 years
- •Knee pain for a duration of ≥ 6 months
- •Knee pain (numeric rating scale ≥4 - ≤8) on at least half of the days in the preceding month at time of inclusion.
- •There is insufficient response of conservative treatment for at least 6 months
- •Radiographic knee osteoarthritis (radiographic Kellgren and Lawrence grade 1-3)
- •Exlusion criteria:
- •Contra-indications for MRI (e.g. metallic foreign bodies, etc.)
- •Contra-indications for angiography
- •Renal insufficiency, checked with blood sample test (GFR < 30 ml/min/1, 73 m2);
- •Known allergy to contrast agents;
- •Patient has known allergies to barium sulfate, 3-aminopropyltrialkoxysilane, polyphosphazene
- •Women who are pregnant or lactating
- •Intermittent claudication of affected limb
- •Intra articular injections in the ipsilateral knee less than 6 months ago
- •On the waiting list for joint replacement surgery
- •Amitriptyline usage.
- •Patient has known allergies to barium sulfate, 3-aminopropyltrialkoxysilane, polyphosphazene.
- •Insufficient command of the Dutch or English language.
- •Legally incompetent adults.
排除标准
- 未提供
结局指标
主要结局
KOOS pain sub score
时间窗: 4 months
KOOS pain sub score after 4 months
次要结局
- ICOAP questionnaire(1,4,8,12 month(s))
- Pain Score 0-10 Numerical Rating Scale (NRS)(1,4,8,12 month(s))
- EQ-5D-5L questionnaire(1,4,8,12 month(s))
- painDETECT questionnaire(1,4,8,12 month(s))
- Total KOOS(1,4,8,12 month(s))
- Pressure pain threshold testing(1,4,8,12 month(s))
- Knee MRI(1 and 4 month(s))
研究者
Dr. Edwin Oei
Principal investigator
Erasmus Medical Center