DRKS00040967进行中(未招募)不适用
Permanent versus Temporary Embolic Agents in Genicular Artery Embolization for the Treatment of Knee Osteoarthritis: A Prospective Observational Study
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 入组人数
- 150
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 Years 至 —(—)
- 性别
- All
入选标准
- •Knee osteoarthritis with radiographic evidence (Kellgren-Lawrence grade 2–4)
- •Knee pain (Numeric Rating Scale [NRS] > 3), refractory to conservative treatment for more than three months
- •Age = 18 years
- •Capacity to consent and provision of written informed consent
排除标准
- •Septic or inflammatory arthritis (e.g., rheumatoid arthritis)
- •Relevant axial malalignment (varus-valgus deviation > 15° on long-leg standing radiographs)
- •Peripheral arterial occlusive disease (> Rutherford grade 3)
- •Known contrast agent allergy
- •Renal impairment (estimated glomerular filtration rate < 30 mL/min/1.73 m²)
- •Contraindications to MRI
- •Planned repeated or bilateral genicular artery embolization during follow-up
研究组 & 干预措施
Group 1: Patients with symptomatic knee osteoarthritis undergo a single genicular artery embolization using permanent Tris-Acryl Gelatin Microspheres (TAGM; 100–300 µm, Embosphere, Merit Medical). Assessment of KOOS (primary endpoint KOOS-Pain) at baseline and at 1, 3, 6, and 12 months. Observation period: 12 months.
干预措施: Group 1: Patients with symptomatic knee osteoarthritis undergo a single genicular artery embolization using permanent Tris-Acryl Gelatin Microspheres (TAGM; 100–300 µm, Embosphere, Merit Medical). Assessment of KOOS (primary endpoint KOOS-Pain) at baseline and at 1, 3, 6, and 12 months. Observation period: 12 months.
研究者
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