NCT01551901Unknown不适用
LIFT: Luna Interbody System for Fusion Trial
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 9
- 主要终点
- Maintenance or improvement of neurologic function related to the spine
研究概览
简要总结
The purpose of this trial is to evaluate the performance, safety and effectiveness of the Luna system for the treatment of degenerative disc disease.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 - 65 at the time of consent
- •Patient has back pain consistent with symptomatic degenerative disc disease at one level or two contiguous levels from L2-S1 requiring surgical intervention.
- •Patient has had at least 6 months of non-operative care
- •Patient is mentally capable and willing to sign a study-specific informed consent form
- •Patient is willing and able to comply with all study requirements
- •Patient has a score on the back pain visual analog scale (VAS) of ≥ 40 mm
- •Patient has an Oswestry Disability Index (ODI) score of ≥ 30%
排除标准
- •DDD affecting >2 levels
- •Back pain due to causes other than DDD
- •Spine surgery within last 3 months or planned spine surgery within 6 weeks of post study procedure
- •>Grade 1 spondylolisthesis or retrolisthesis
- •Infection at or close to target disc level
- •Active systemic infection
- •Patient has known osteoporosis
- •Prior interbody fusion at the target level
- •Prior failed interbody fusion at any level
- •Known allergy to device materials
- •Uncontrolled psychiatric illness or severe dementia
- •Pregnant at time of enrollment or considering getting pregnant during study period
- •Any metabolic or other bone disease that could significantly compromise pedicle screw and/or interbody device placement.
- •Any severe illness that would prevent complete study participation
- •Uncontrolled diabetes
- •Current use of chronic steroids (more than equivalent of 10 mg prednisone daily)
- •Contraindication to spinal surgery or general anesthesia
- •Coagulopathy
- •Body mass index >35
- •Current smoker
- •Known illicit substance abuser
- •Currently participating in another investigational study that could affect responses to the study device
结局指标
主要结局
Maintenance or improvement of neurologic function related to the spine
时间窗: 12 Month Post-op
Proportion of subjects with device in place showing lack of device migration or subsidence and absence of device related serious adverse event
时间窗: 12 Month Post-op
Improvement in pain score on the Visual Analog Scale (VAS) from baseline
时间窗: 12 Month Post-op
Proportion of subjects with lack of revision, removal, reoperation or use of additional supplemental fixation
时间窗: 12 Month Post-op
Improvement in Oswestry Disability Index (ODI) score from baseline
时间窗: 12 Month Post-op
次要结局
- Improvement from baseline in quality of life as measured by SF-36(12 Month Post-op)
- Rate of device-related serious adverse events(12 Month Post-op)
- Proportion of subjects with radiographic fusion of target segments(12 Month Post-op)
研究者
研究点 (9)
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