Trans Arterial Embolization for Facet Arthropathy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Number of Procedure-Related Serious Adverse Events in the Perioperative Period
研究概览
简要总结
This single-site, single-arm study evaluates the feasibility, safety, tolerability, and efficacy of trans-arterial embolization (TAE) using Embozene microparticles for treating facetogenic pain due to facet arthropathy (osteoarthritis of the facet joints) in the lumbar spine.
详细描述
This is a single site, single-arm study assessing the feasibility, safety, tolerability, and efficacy of trans-arterial embolization for the treatment of facet pain due to facet arthropathy. Osteoarthritis is a common and major cause of pain and disability. Each spinal level contains multiple joints including the intervertebral discs as well as the facet joints. Degeneration of the facet joints or facet arthritis begins early in life and the prevalence grows with increasing age ultimately reaching as high as 100% in people over 60 years of age. Facet arthritis can lead to the development of facetogenic pain. Previous studies have suggested that trans-arterial embolization may be beneficial for pain in the setting of osteoarthritis. Trans-arterial injections have been described in the knee, hip, and shoulder.
Embolization of the dorsal branches of the segmental arteries supplying the bony elements of the spine is a well-established technique employed for preoperative embolization of bony spinal tumors and metastatic disease. Previous studies have clearly demonstrated safety of the techniques with low overall risk. In one large series of 100 embolizations there was only one recorded complication due to the embolization. However, it has not been described for use in the setting of facet arthropathy (OA of the facet joint). The PI for this study has published the results of large series of embolization for spinal tumors without any serious adverse events. Currently the treatment of lumbar spine OA involved medical management, followed by minimally invasive techniques such as intraarticular injection and neurolysis, which are of questionable efficacy, and ultimately possible spinal surgery and fusion in the setting of degenerative disease and structural abnormalities. The purpose of this study is to demonstrate the safety and preliminary efficacy of trans-arterial facet joint embolization using Embozene microparticles in patients with facet arthropathy and lumbar spine OA.
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
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-85
- •Confirmed diagnosis of spinal facet arthropathy on MRI OR CT
- •Confirmed diagnosis of lumbosacral facetogenic pain based on diagnostic nerve blocks.
- •Failed medical management of pain.
- •Back pain persistent for at least 6 months
- •Pain worse than at least 6/10 on a visual analog pain scale
- •Failed at least one of either intra-articular injections of steroids/ anesthetics or neuro-ablative procedure.
- •Maximum of 2 spinal levels of facetogenic pain in the lumbar and sacral spine (i.e. L4-5 and L5-S1).
- •Modified Rankin Scale 0-2
排除标准
- •- Pregnancy
- •History of prior spinal embolization at the target level.
- •History of surgery/ stenting of the aorta at the level of embolization.
- •Severe allergic reaction to iodinated contrast (i.e. anaphylaxis)
- •Creatinine > 1.5 mg/dl and/or creatinine clearance < 60 mL/min (except if patients is already on hemodialysis).
- •Modified Rankin Scale >2
- •Angiographic/ Procedural Exclusion Criterion: Vascular supply to the spinal cord from the vessels supplying the facet joints targeted for embolization.
研究组 & 干预措施
Embozene Microspheres for Facetogenic Low Back Pain
This is a single site, single arm study to assess the safety and efficacy of trans arterial embolization using Embozene microspheres of the facet joint for the treatment of facetogenic low back pain.
干预措施: Spinal angiography and embolization/ Embozene Microspheres (Device)
结局指标
主要结局
Number of Procedure-Related Serious Adverse Events in the Perioperative Period
时间窗: 1 year
The primary outcome measurements for safety are: -The number of procedure-related serious adverse events occurring in the perioperative period
次要结局
- Proportion of Patients with >20% Improvement in Facetogenic Pain Based on Visual Analog Scale (VAS). Percent from 0% to 100% and higher % represents greater improvement.(1 year)
- Proportion of Patients with >20% Improvement in Disability Based on Oswestry Low Back Pain Disability Questionnaire(1 year)