跳至主要内容
临床试验/DRKS00040967
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

Universitätsklinikum Düsseldorf0 个研究点目标入组 150 人开始时间: 2024年1月1日最近更新:
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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