NL-OMON36302撤回不适用
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. - NICE - Neurogenic Intermittent Claudication Evaluation study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •*Presence of symptomatic DLSS in the L1-L5 region confirmed by MRI at 1 or maximum 2 levels
- •*Presence of NIC, defined as a feeling of paresthesia and/or discomfort and/or pain and/or weakness in the leg(s) during walking or prolonged standing, with or without back pain, buttock and/or groin pain which are relieved in flexion
- •*Leg pain must be more pronounced than back pain. Leg pain VAS score must at least be 2 points higher than back pain VAS score.
- •*Average disc height *defined as the mathematical mean of the anterior and the posterior disc height measured in the mid-sagittal MRI- at the index level(s) is * 5mm.
- •*According to the current standard of care patient would be candidate for Standalone Decompressive Surgery (no instrumentation, no stabilization or fusion)
- •*Patient states availability and willingness to perform all follow-up examinations
- •*Patient has signed Informed Consent form (ICF)
- •*Patient is 21 years old or older
- •*Duration of the patient*s leg symptoms is at least 6 weeks at screening
- •*Patient has no financial interest in participating in the study (e.g.: workers compensation etc)
排除标准
- •*Patient had undergone a previous lumbar surgery at any lumbar level
- •*Patient has unremitting pain (leg, buttock/groin) in any spinal position
- •*Patient is candidate for instrumented decompressive surgery (decompression with stabilization/fusion)
- •*Patient has back pain without leg pain
- •*Degenerative Spondylolisthesis greater than Grade 1 on the Meyerding grading system
- •*Spondylolysis (fracture or defect of the isthmus/pars interarticularis)
- •*Spinous process fracture at any lumbar level
- •*Ankylosis at the affected level
- •*Fixed motor deficit
- •*Symptomatic DLSS at more than 2 levels in the lumbar region
- •*Spinal stenosis is present at L5-S1 level
- •*Symptomatic disc herniation causing radiculopathy
- •*Patient*s anatomical features do not allow appropriate placement of the device
- •*BMI of patient equal to or higher than 35
- •*Scoliosis with Cobb angle * 25°
- •*Kyphosis requiring surgical correction
- •*Paget*s disease
- •*Tumor of the spine
- •*Presence of vascular claudication
- •*History of one or more osteoporotic spinal fragility fracture(s), determined on full spine X-ray
- •*Active systemic infection or local infection at the target level(s)
- •*Major Depression according to the DSM IV criteria
- •*Dementia and/or inability to give Informed Consent
- •*Unable to complete the study
- •*Pregnancy, breastfeeding or planned pregnancy
- •*Allergy to any of the components of the Aperius device, inserter or the distractors.
- •*Patients with specific contraindications for MRI: (claustrophobia, cardiac pacemaker, implanted cardiac defibrillator, aneurysm clips, neurostimulator, insulin pump, implanted drug infusion device, bone growth/fusion stimulator and cochlear -, or otologic implant)
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