A Multicenter Prospective Randomized Controlled Clinical Trial to Evaluate the Effectiveness and Safety of the Aperius™ PercLID™ System Versus Standalone Decompressive Surgery in Degenerative Lumbar Spinal Stenosis With Neurogenic Intermittent Claudication
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 163
- 试验地点
- 36
- 主要终点
- Mean Percentage Change From Baseline in Physical Function at 1 Year Follow-up Using the Patient Completed Zurich Claudication Questionnaire
研究概览
简要总结
The objective of the NICE study is to provide clinical evidence proving that the Aperius™ PercLID™ System is safe and non-inferior to standalone decompressive surgery with regards to clinical outcomes in patients suffering from Degenerative Lumbar Spinal Stenosis with Neurogenic Intermittent Claudication, relieved by flexion.
详细描述
The NICE study is a Multicenter Prospective Randomized Controlled Clinical Trial to Evaluate the Effectiveness and Safety of the Aperius™ PercLID™System Versus Standalone Decompressive Surgery in Degenerative Lumbar Spinal Stenosis with Neurogenic Intermittent Claudication.
DLSS patients suffering from NIC that would be candidates for surgical treatment without stabilization and/or fusion can be offered participation in the study. After randomization, patients will be treated with either the Aperius™ PercLID™ System or Standalone Decompressive Surgery (SDS). A sample size recalculation reduced the amount of patients to be enrolled from 280 to 128 in both treatment group.
The patient will undergo a study visit at screening / baseline and at 14 days, 6 weeks, 6, 12 and 24 months after surgery. Safety data will be collected during surgery and throughout the 24 months follow up. Procedural details will be collected during surgery and also duration of hospital stay will be collected. At screening / baseline and all follow up visits a physical examination will be performed, the use of pain medication will be documented and the subject will be asked to complete a pain VAS scale (back - leg - buttock / groin pain) and questionnaires (SF36 v2 and Zurich Claudication Questionnaire).
Study subjects are required to undergo X-ray, CT and MRI and fluoroscopy procedures at specified time points during the study.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Presence of symptomatic DLSS
- •Presence of NIC
- •Patient would be candidate for Standalone Decompressive Surgery
- •Patient has signed Informed Consent form (ICF)
- •Patient is 21 years old or older
排除标准
- •Previous lumbar surgery
- •Patient is candidate for instrumented Decompressive Surgery
- •Patient has back pain without leg pain
- •Degenerative Spondylolisthesis greater than grade 1 (Meyerding)
- •Symptomatic DLSS at more than 2 levels in the lumbar region
- •Spinal stenosis is present at L5-S1 level
结局指标
主要结局
Mean Percentage Change From Baseline in Physical Function at 1 Year Follow-up Using the Patient Completed Zurich Claudication Questionnaire
时间窗: 1 year
ZCQ is a validated outcomes instrument specific to lumbar spinal stenosis, and captures data in 3 distinct domains: Physical function (PF), Symptom Severity (SS), and post-treatment Patient Satisfaction (PS).PF score is the mean score of five physical function questions of ZCQ, ranging from 1 to 4. A lower score represents a better outcome/condition. Mean percentage change from baseline in Physical Function at 1 year follow-up was reported.
次要结局
- Mean Percentage Change From Baseline in Physical Function, Using Patient Completed Zurich Claudication Questionnaire(14 days, 6 weeks, 6 months, and 24 months)
- Mean Percentage of Change From Baseline in Symptom Severity of the Patient Completed Zurich Claudication Questionnaire(14days, 6 week, 6 months, 12 months, 24 months)
- Mean Percentage Change of Visual Analog Scale (VAS) From Baseline in Leg Pain(14 days, 6 weeks, 6 months, 12 months, and 24 months)
- Patient Satisfaction (PS) Scores of Zurich Claudication Questionnaire(14 days, 6 weeks, 6 months, 12 months, and 24 months)
- Mean Percentage Changes From Baseline in Quality of Life Using the Patient-completed SF-36 Questionnaire(14 days, 6 weeks, 6 months, 12 months, and 24 months)
- Number of Subjects Requiring Secondary Surgical Intervention(Overall study period, up to 24 months)
- Percentage of Subjects With Serious Adverse Device Effects(Overall study period, up to 24 months)
- Changes in Stenosis of the Spinal Canal Assessed by Magnetic Resonance Imaging (MRI) at the Follow-up Time Points(baseline, 12 months, and 24 months)
- Bony Structure Changes of Spinous Process Assessed by CT at the Follow-up Time Points(baseline, 12 months, and 24 months)
- Correlation Between Changes in Spinal Central Canal Stenosis and Changes in Patient Reported Outcomes-Back Pain(12 months and 24 months)
- Correlation Between Changes in Spinal Central Canal Stenosis and Changes in Patient Reported Outcomes-leg Pain(12 months and 24 months)
- Correlation Between Changes in Spinal Central Canal Stenosis and Changes in Patient Reported Outcomes-ZCQ Physical Function(12 months and 24 months)
- Correlation Between Changes in Spinal Central Canal Stenosis and Changes in Patient Reported Outcomes-ZCQ Symptom Severity(12 months and 24 months)
- Number of Patients With Improvement of Symptoms, Symptoms Recurrence, Decreased Therapeutic Response, no Therapeutic Response and Treatment Failure at 14 Days, 6 Weeks, 6, 12 and 24 Months(14 days, 6 weeks, 6 months, 12 months, and 24 months)