Symptomatic Efficacy of Microparticle Arterial Embolization in Knee Osteoarthritis Resistant to Medical Treatment: Randomized Prospective Study Versus Placebo
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 4
- 主要终点
- VAS : Change of pain of the Knee injury
研究概览
简要总结
The aim of this double-blind, randomized, single-center prospective study (patient and evaluator) is to evaluate the efficacy of arterial occlusion (embolization) of neovessels by microparticle versus placebo on pain in disabling knee osteoarthritis at 12 months.
详细描述
Rational: in the normal state, the articular cartilage is devoid of vessels and innervation. In osteoarthritic cartilage, neovascularization is observed and is accompanied by a sensitive neoinnervation. The development of these neovessels also contributes to the structural damage of cartilage by achieving a real "perforation"of the cartilage. Studies designate neovascularization as a target for new therapeutic. In two non-comparative open-label studies, a Japanese team has shown that endovascular occlusion of these neovessels in patients with knee osteoarthritis significantly reduced the patient pain without any complication.
The aim of this double-blind, randomized, single-center prospective study (patient and evaluator) is to evaluate the efficacy of arterial occlusion (embolization) of neovessels by microparticle versus placebo on pain in disabling knee osteoarthritis at 12 months.
The main objective is to evaluate the effectiveness of embolization on the pain of patients with disabling osteoarthritis by double-blind comparison of two groups: the first control group will include patients who will benefit from arteriography and an injection of saline in their neovessels, the second group called treatment will consist of patients whose neovessels will be occluded by inert microparticles of 75 µm. The pain will be evaluated in both groups before and 12 months after embolisation. The objective is to show that the pain is significantly less important in the group of patients whose neovessels have been occluded with microparticles in comparison to the control group.
Secondary objectives are to evaluate the effectiveness of neovascular embolization on pain at 1, 6, 24 and 36 months; knee stiffness, physical activity, quality of life, at 1, 6, 12, 24 and 36 months; the structural course of knee osteoarthritis at 12, 24 and 36 months; the use of arthroplasty at 24 and 36 months.
Study Population: Patients aged 40 to 80 years with knee osteoarthritis with a visual analogue scale (VAS) score greater than or equal to 50 mm for at least 3 months optimal medical treatment, whose radiological stage of osteoarthritis according to Kellgren and Lawence is 2 or 3 and does not have a knee prosthesis surgical indication.
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, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •An effective contraceptive system for women of childbearing age, a pregnancy test will be offered to these women in the preoperative assessment.
- •Obtaining the signature of the consent to participate in the study
- •Kellgren-Lawrence (KL) grade 2-3 assessed by routine weight-bearing knee radiographs on the most affected knee in bilateral cases
- •Pain with EVA ≥ 50 mm evolving for at least 3 months despite the start of a well-conducted medical treatment according to current recommendations including analgesics, NSAID, intra-articular injections, rehabilitation and weight loss
- •No surgical indication retained
排除标准
- •Serious visceral failure
- •Local infection
- •Arthropathy secondary to chronic inflammatory rheumatism (rheumatoid arthritis, spondylarthritis) or microcrystalline rheumatism
- •History of surgery on the studied knee, except arthroscopy for more than 6 months
- •Gonarthrosis with KL score> 3
- •Osteonecrosis of one of the bones of the knee joint on the MRI
- •Pregnant or lactating woman
- •Allergy to contrast products
- •Chronic or acute renal failure (clearance <30 ml / min)
- •Haemostasis disorders (blood platelet count <50,000 / mm3 or patient ACT / control ACT> 1,2 or PT <50%)
- •Operative indication of placement of a prosthesis
研究组 & 干预措施
Microparticles
arteriography and an injection of inert microparticles of 75 µm in neovessels
干预措施: Arteriography (Procedure)
Placebo
knee arteriography and injection of saline solution in neovessels
干预措施: Arteriography (Procedure)
结局指标
主要结局
VAS : Change of pain of the Knee injury
时间窗: before intervention and one month, 6 months, 12 months, 24 months and 36 months after intervention
change in the Visual Analog Scale of Pain Intensity (VASPI).
次要结局
- EQ-5D questionnaire(at 1, 6, 12 and 36 month after intervention)
- Knee X-Ray(15 days before embolization and 12, 24, 36 month after)
- Knee injury and Osteoarthritis Outcome Score (KOOS)(at 1,6, 24, 36 month after intervention)
- Knee MRI(15 days before embolization and 12 month after)