Genicular Artery Embolization (GAE) vs inTra-articular Corticosteroid Injection for Osteoarthritic Knee Pain. (GET-IN Study)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Primary Efficacy Endpoint: numeric rating scale (NRS)
研究概览
简要总结
This study investigates genicular artery embolization (GAE) as a minimally invasive alternative to ntra-articular corticosteroid injections (IA) or treating knee osteoarthritis (OA) pain. Designed as a randomized controlled tria, the study compares pain relief effectiveness and safety between GAE and IA over a 12-month follow-up. Eligible participants are aged over 40 with symptomatic knee OA resistant to conservative treatment. Primary outcomes focus on pain reduction (NRS score), while secondary measures include function, quality of life, imaging findings, and adverse events.
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
- Single (Participant)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 40 years
- •Symptomatic knee pain, with numeric rating scale (NRS) ≥
- •Insufficient or resistant to conservative treatment, including oral analgesics, physical therapy, intra-articular injections for at least 3 months, before the enrollment.
- •Weight bearing X ray of knee: osteoarthritis of Kellgren-Lawrence grade 1, 2, or 3.
排除标准
- •History of trauma in recent 6 months.
- •Bleeding tendency.
- •Poor renal function (serum creatinine > 2.0 mg/dL).
- •Pregnancy or breast-feeding.
- •Severe peripheral arterial occlusive disease (PAOD).
- •Local infections or inflammatory arthritis of knee.
- •Rheumatoid arthritis or other rheumatological diseases.
- •Prior knee surgeries (arthroscopic surgery, menisci repair, cruciate ligament reconstruction, arthroplasty of knee) due to knee pain.
- •ECOG > grade 2
- •Life expectancy less than 2 years.
- •Any other condition related to the patient's health, regarded exclusionary in the opinion of the investigator.
研究组 & 干预措施
Experimental arm: GAE (IPM/CS).
Genicular artery embolization with imipenem/cilastatin (IPM/CS).
干预措施: Genicular artery embolization (Procedure)
Comparator: IA (corticosteroids)
The patient will receive IA procedure and sham GAE procedure.
干预措施: Intra-articular injection with corticosteroids. (Procedure)
结局指标
主要结局
Primary Efficacy Endpoint: numeric rating scale (NRS)
时间窗: Post-intervention 3 month.
Changes of pain score (NRS) at the 3-month compared with the baseline.
次要结局
- Clinical Efficacy: numeric rating scale (NRS)(In the one-year period after intervention.)
- Clinical Efficacy: WOMAC(Pre-intervention, post-1, 3, 6, 12 months)
- Clinical Efficacy: Lequesne'Index(Pre-intervention, post-1, 3, 6, 12 months)
- Clinical Outcome: PGIC(Pre-intervention, post-1, 3, 6, 12 months)
- Clinical Outcome: Analgesic Usage and other Pain Control Treatments(Pre-intervention, post-1, 3, 6, 12 months)
- Clinical Outcome: Quality of Life(Pre-intervention, post-1, 3, 6, 12 months)