A Prospective, Multi-center, Randomized Controlled Double-Blind Trial Evaluating the VertiFlex® Totalis™ Direct Decompression System Versus a Sham Comparator Surgical Procedure in Patients With Lumbar Spinal Stenosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 180
- 试验地点
- 38
- 主要终点
- Percentage of Subjects With Clinically Significant Improvement in Outcomes
研究概览
简要总结
The purpose of this study is to determine safety and effectiveness, as measured by changes in pain, disability, patient satisfaction, and claudicatory symptoms, at 6 months following treatment with the Totalis™ Direct Decompression System or Sham Comparator Surgical Procedure in patients with lumbar spinal stenosis
详细描述
Subjects suffering from symptoms of neurogenic intermittent claudication secondary to a radiographically-confirmed diagnosis of central canal stenosis, with or without mild or moderate lateral recess stenosis, at one or two levels from L1 to L5 who meet all inclusion/exclusion criteria, including ≥6 months of non-operative management.
Patients included in the clinical investigation will return for follow-up visits at 1 week for safety evaluation, and at 6 weeks, 3 months, 6 months, 12 months, 18 months and 24 months post-treatment to collect data for evaluation of safety and effectiveness.
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
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subjects greater than or equal to 55 years of age
- •Neurogenic intermittent claudication (NIC) symptoms defined generally as leg/buttock/ groin pain and/or paresthesias that are exacerbated with standing and walking and relieved by flexion
- •VAS leg symptom severity >50 (in either leg) during episodes of neurogenic claudication
- •Subjects who are able to walk a minimum of 50 feet without experiencing NIC symptoms
- •Diagnosis of central canal spinal stenosis, with or without mild to moderate lateral recess stenosis, at one or two levels from L1-L5 with radiologic evidence
- •Subjects with persistent lumbar spinal stenosis symptoms that, during the course of the last year, have been unresponsive to a minimum of 6 months of conservative therapy
排除标准
- •Significant back, buttock or leg pain from causes other than lumbar central canal stenosis
- •Axial back pain only
- •Severe foraminal stenosis at index level(s) and/or symptomatic foraminal stenosis at any lumbar level
- •Severe lateral recess stenosis
- •Lumbar spinal stenosis at more than two levels determined pre-operatively to require surgical intervention
- •Prior decompressive surgery at index level (s) or fusion at any lumbar level
- •Epidural steroid or nerve block steroid injection at index level(s) within 6 weeks of baseline assessments
- •Spondylolisthesis (anterolisthesis or retrolisthesis) greater than grade 1
- •Spondylolysis (pars fracture)
- •Significant degenerative lumbar scoliosis at index level(s)
- •Morbid obesity
- •Significant peripheral vascular disease
- •Active significant co-morbidity
- •Undergoing immunosuppressive therapy or long-term steroid use
- •Current spinal cord stimulator or implanted pain pump
- •Life expectancy less than 2 years
- •Evidence of substance abuse within the year
- •Involvement or potential involvement in litigation related to the spine or worker's compensation related to a back and/or leg issue
结局指标
主要结局
Percentage of Subjects With Clinically Significant Improvement in Outcomes
时间窗: Baseline and 6 Months
Where clinically significant improvement in outcomes is defined as improvement in any 2 of the 3 domains of the Zurich Claudication Questionnaire ( ZCQ) * Improvement in physical function by ≥ 0.5 points from baseline * Improvement in symptom severity by ≥ 0.5 points from baseline * Patient Satisfaction Score of \< 2.5 points And no interventions of the following nature through 6 months: * Re-operations or revisions at index level(s) intended to treat stenosis * Epidural steroid injection or selective nerve root block at index level(s) And no unblindings
次要结局
未报告次要终点