Genicular Artery Embolization as Pain Treatment of Mild to Moderate Knee Osteoarthritis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 2
- 主要终点
- Changes in Visual Analog Scale (VAS) as a measure of efficacy
研究概览
简要总结
The aim of this study is to investigate the safety and efficacy of geniculate artery embolization (GAE) as pain treatment in patients with mild to moderate knee osteoarthritis.
详细描述
This is a single arm, prospective, pilot study investigating the safety and efficacy of GAE as pain treatment in patients with mild to moderate knee osteoarthritis. Patient related outcome measurements (PROMs), physical tests and several image modalities will be conducted.
It may form the grounding for further research in the shape of a larger randomized clinical trial.
The hypothesis is, that GAE will reduce synovitis and thereby pain in the patient group. This may secondary improve physical function and reduce consumption of analgesics.
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
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Body Mass Index < 35 kg / m
- •X-ray verified mild to moderate KOA (Kellgren Lawrence grade 1-3 [24]), obtained maximum 6 months prior to inclusion.
- •Moderate to severe knee pain during walking (Visual Analog Scale (VAS) > 50 mm) - resistant to minimum 3 months physiotherapy.
- •Willing, able, and mentally competent to provide informed consent.
排除标准
- •Local infection in knee or groin areas.
- •Moderate to severe pain in ipsilateral lower limb joints; VAS >
- •Intermittent claudication.
- •Rheumatoid arthritis or seronegative arthropathies.
- •Prior ipsilateral open knee surgery.
- •Ipsilateral arthroscopy within 6 months.
- •Ipsilateral intra-articular knee injection within 6 months.
- •Current/recent (within 4 weeks) use of oral corticosteroids.
- •Generalized pain syndrome (e.g. fibromyalgia) or nerve root compression syndromes.
- •Pregnant or planned pregnancy during the study period.
- •Lactation.
- •Active malignancy.
- •Known history of allergy to contrast media.
- •Contra-indications for MRI (e.g. metallic foreign bodies, etc).
- •Manifest hyperthyroidism.
- •Diabetes (I+II).
- •Liver disease.
- •Only one kidney, former kidney surgery, reduced kidney function or failure (chronic or acute).
- •Estimated glomerular filtration rate < 60 ml / min / 1.73 m2 (All participants: blood sample maximum 30 days prior to GAE. Participants > 60 years: another blood sample maximum 3 months prior to last MRI scan with contrast agents).
- •INR > 1.4, Platelets ≤ 40 x 109 / l (All participants: blood sample maximum 30 days prior to GAE).
- •Antithrombotic treatment except acetylsalicylic acid.
- •Diseases affecting the bone metabolism (E.g. severe osteoporosis, Paget's disease, or hyperparathyroidism).
- •American Society of Anesthesiologists classification > 3.
结局指标
主要结局
Changes in Visual Analog Scale (VAS) as a measure of efficacy
时间窗: 6 months post GAE
Reported as worst pain experienced during walking in the last 24 hours on a 100 mm scale from "No pain" to "Pain as bad as it could possibly be".
次要结局
- Dexa scan(Baseline vs 6 months post GAE)
- Changes in Visual Analog Scale (VAS) as a measure of efficacy(1 week, 1, 2, 3, 4, and 5 months post GAE)
- Changes in Knee injury and Osteoarthritis Outcome Score (KOOS)(Baseline vs. 1 week, 1, 2, 3, 4, 5, and 6 months post GAE.)
- Subjective response to the treatment on a five point Likert scale(6 months post GAE)
- MRI(Baseline vs. 1 and 6 months post GAE)
- Ultrasound(Baseline vs. 1 and 6 months post GAE)
- Changes in IPAQ (international physical activity questionnaire)(Baseline vs. 1 week, 1, 2, 3, 4, 5, and 6 months post GAE)
- Changes in use of analgesics(Baseline vs. 1 week, 1, 2, 3, 4, 5, and 6 months post GAE)
- Changes in 30 seconds Chair Stand Test(Baseline vs. 1 and 6 months post GAE.)
- Changes in Stair Climb Test(Baseline vs. 1 and 6 months post GAE.)
- Changes in 40 meters Fast Paced Walk Test(Baseline vs. 1 and 6 months post GAE.)
研究者
Louise Hindso
Doctor of Medicine
Rigshospitalet, Denmark