NCT01970514Unknown早期 1 期
Temporary Axial Rotation Stabilization for Lumbar Disc Prolapse Surgery With the ARO® Spinal System: A Non-randomized Prospective Analysis of Clinical Efficacy, Safety and Cost Effectiveness
ARO Medical2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2012年4月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 早期 1 期
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Safety profile compared to historical controls and improvement in leg and back pain
研究概览
简要总结
To evaluate the clinical safety and effectiveness of the ARO Spinal System and to assess preliminary cost/benefit analysis in patients undergoing decompression surgery for symptomatic lumbar disc herniations.
The general hypothesis is that the ARO significantly improves outcomes in patients undergoing decompression surgery for symptomatic lumbar disc herniations.
详细描述
Not provided
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Radicular pain and evidence of nerve-root irritation lasting 6 weeks or more as evidenced by both:
- •Radicular pain - below the knee,
- •Nerve root irritation
- •i. positive nerve root tension sign - straight leg raise positive between 30 and 70 degrees, or ii. positive femoral tension sign, or iii. neurologic deficit - asymmetrical depressed reflex or decreased sensation in a dermatomal distribution or weakness in a myotomal distribution.
- •Primary one-level posterolateral herniation in the lower lumbar spine (L4-L5 or L5-S1 only) as shown by magnetic resonance (MR) imaging (protrusion, extrusion or sequestered fragment) consistent with the clinical symptoms (both level and side).
- •The investigator confirms that the patient is a surgical candidate for discectomy,
- •The patient has been scheduled for their surgical procedure no more than two months from time of consent,
- •18 years to 55 years of age at time of consent,
- •Willing to complete the study requirements and permit agency and sponsor authorized personnel to access medical records,
- •Able to understand oral and written Danish.
排除标准
- •Previous lumbar surgery
- •Cauda equine syndrome
- •Scoliosis greater than 15 degrees
- •Osteoporosis
- •Segmental instability (> 10 degrees angular motion or >4mm translation)
- •Vertebral fractures
- •Spinal Infections
- •Spinal tumors
- •Inflammatory spondyloarthropathy
- •Pregnancy or the intent to become pregnant in the following year
- •Comorbid conditions contraindicating surgery
- •Multiple herniations
- •Known allergy to titanium, aluminum or vanadium
- •Female patients of childbearing age, who are not willing to use adequate contraception specified as: intrauterine devices, hormonal contraceptives (contraceptive pills, implants, transdermal patches, hormonal vaginal devices or injections with prolonged release). It is accepted in certain cases to include subjects having a sterilized permanent partner or subjects using double barrier contraceptive methods which is a condom combined with a diaphragm.
研究组 & 干预措施
ARO Spinal System
Experimental
ARO Spinal System
干预措施: ARO Spinal System (Device)
结局指标
主要结局
Safety profile compared to historical controls and improvement in leg and back pain
时间窗: One year
次要结局
- Oswestry Disability Index (ODI) improvement is superior to historical control(1 year)
- VAS back pain improvement is superior to historical control(1 year)
- VAS leg pain improvement is superior to historical control,(1 year)
研究者
研究点 (2)
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