NCT04054401招募中不适用
SynerFuse Spinal Fusion and Neuromodulation Proof of Concept Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 4
- 主要终点
- Primary Safety Endpoint: Characterization of device-related adverse events
研究概览
简要总结
The purpose of the study is to evaluate the safety and tolerability of DRG stimulation when placing a neurostimulator during the same procedure as implantation of spinal fixation with or without interbody cage systems in patients with chronic back and/or leg pain requiring single level spinal fusion.
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
- 21 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Indicated for a single level or two level adjacent spinal fusion having back pain and radiculopathy
- •Have been diagnosed with chronic, intractable pain of the lower back and/or leg refractory to conservative therapy for at least 3 of months
- •At least 6 months since last surgical procedure on the spine
- •Be 21 years of age or older at the time of enrollment
- •Be willing and capable of giving informed consent
- •Be willing and able to comply with study-related requirements
排除标准
- •Any prior spinal fusion at index or adjacent level
- •Have a life expectancy of less than 1 year
- •Be concomitantly participating in another clinical study
- •Be involved in an injury claim under current litigation
- •Baseline narcotic use of ≥ 100 MME per day
- •Significant untreated addiction to dependency producing medications
- •Current active implantable medical device
- •Have osteoporosis
- •Active infection
- •Allergies to system components
- •AGE > 80
- •Expected need to undergo MRI imaging in the future
- •Other significant comorbidities
结局指标
主要结局
Primary Safety Endpoint: Characterization of device-related adverse events
时间窗: Surgery through 12 months post-op
Primary Effectiveness Endpoint: Change in back and leg pain Visual Analog Score (VAS) scores
时间窗: Baseline to 3 months post-op
VAS scores range from 0 (no pain) to 100 (pain is as bad as it could possibly be). Decreases in scores indicate reductions in pain.
次要结局
- Change in quality of life as measured by EQ-5D-5L.(Baseline to 3, 6, and 12 months post-op)
- Change in neurological status(Baseline to 3, 6, and 12 months post-op)
- Change in quality of life as measured by PROMIS Scale v1.2 - Global Health.(Baseline to 3, 6, and 12 months post-op)
- Change in disability measured by the Oswestry Disability Index (ODI).(Baseline to 3, 6, and 12 months post-op)
- Change in use of analgesics over time(Baseline through 12 months post-op)
研究者
研究点 (4)
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