NCT05258435进行中（未招募）不适用
Long-term Assessment of the Safety and Performance of the NuVasive Simplify Disc
NuVasive10 个研究点 分布在 1 个国家目标入组 131 人开始时间: 2022年2月9日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 131
- 试验地点
- 10
- 主要终点
- Clinical Composite Success
研究概览
简要总结
A prospective, multicenter post-market clinical follow-up study to evaluate the 10-year long-term safety and effectiveness of the Simplify Disc in subjects who were enrolled in the post approval study (NCT04630626).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject was enrolled in the Simplify Disc post approval study (NCT04630626) at a participating study site
- •Subject understands the conditions of enrollment and is willing to sign an informed consent form to participate in the study
排除标准
- •Subject had an SSI at the index level during the post approval study (NCT04630626)
- •Subject was withdrawn or withdrew consent to participate in the post approval study (NCT04630626)
结局指标
主要结局
Clinical Composite Success
时间窗: 10 years
Individual patient success for the primary endpoint will be assessed at 120 months and is defined as follows: 1. Improvement on the Neck Disability Index (NDI) of at least 15 percentage points compared to baseline (pre-op), and 2. No device failures by month 120, and 3. No secondary surgical intervention (SSI) at the index level (i.e., revision, removal, reoperation, or supplemental fixation) by month 120.
次要结局
- Sensory status at each annual timepoint compared to baseline(10 years)
- Displacement or migration of the Simplify Disc at each annual timepoint will be compared to the post-op timepoint in the IDE study (NCT02667067)(10 years)
- Motor status at each annual timepoint compared to baseline(10 years)
- Treatment satisfaction questionnaire at each annual timepoint(10 years)
- Percentage of subjects meeting the minimal clinically important difference (MCID) for NDI at each annual timepoint(10 years)
- Disc height at each annual timepoint will be compared to baseline(10 years)
- Percentage of subjects meeting MCID for Visual Analog Scale (VAS) for each of the following pain locations and each annual timepoint: neck and arm pain, neck only pain, left arm pain, and right arm pain(10 years)
- Dysphagia Handicap Index1 (DHI) at each annual timepoint compared to baseline(10 years)
- Adjacent level disc degeneration (ALDD) at each annual timepoint will be compared to baseline(10 years)
- Rate of adverse events attributable to Simplify Disc, or use of additional NuVasive instruments, implants, or technologies at each annual timepoint(10 years)
- Range of motion (ROM) at each annual timepoint compared to baseline(10 years)
- SF-12v2® Health Survey at each annual timepoint compared to baseline(10 years)
研究者
研究点 (10)
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