A Multi-Center Randomized Controlled Trial of the In-Space Compared to X STOP® for Treatment of Moderate Degenerative Lumbar Spinal Stenosis
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 44
- 试验地点
- 19
- 主要终点
- Zurich Claudication Questionnaire(ZCQ)
研究概览
简要总结
The purpose of this study is to evaluate the safety and effectiveness of the In-Space compared to the X STOP Interspinous Process Distraction (IPD) device ("X STOP") for the treatment of patients experiencing intermittent neurogenic claudication secondary to moderate degenerative lumbar stenosis at one or two lumbar levels.
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
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 50 years in age
- •Leg/buttock/groin pain, with or without back pain, that can be completely relieved by flexion such as when sitting in a chair.
- •Zurich Claudication Questionnaire Score ≥ 2.0,
- •Neurogenic intermittent claudication secondary to moderate lumbar spinal stenosis
- •Has completed at least 6 months conservative therapy
排除标准
- •Axial back pain only without leg/buttock/groin pain
- •Has had any prior lumbar spine surgery at any level
- •Significant scoliosis, defined as Cobb angle > 10°
- •Spondylolisthesis > Grade 1 or isthmic spondylolisthesis at affected level
- •Osteoporosis
- •Morbid obesity, defined as BMI > 40 kg/m2
研究组 & 干预措施
1
In-Space
干预措施: Interspinous Spacer device (Device)
2
X STOP
干预措施: Interspinous Process Distraction Device (Device)
结局指标
主要结局
Zurich Claudication Questionnaire(ZCQ)
时间窗: 24 months
The questionnaire quantifies severity of symptoms, physical function characteristics, and patient's satisfaction. The scale relates to symptoms over the past month. The result is expressed as a percentage of the maximum possible score. The score increases with worsening disability. An individual patient treatment will be considered a success if they meet at least two of three components defined as an improvement of ≥ 0.5 as compared to preoperative score for the symptom severity and physical function and an of \< 2.5 points for patient satisfaction at 24 months.
次要结局
- Oswestry Disability Index (ODI)(24 months)