Long-Term Assessment of the Safety and Performance of the NuVasive Simplify Disc at Two Levels
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 158
- 试验地点
- 2
- 主要终点
- Clinical Composite Success Rate
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 at two levels in subjects who were enrolled in the IDE study (NCT03123549) and/or post approval study (NCT04980378).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject was enrolled in the Simplify Disc IDE (NCT03123549) and/or PAS (NCT04980378) at a participating study site
- •Patient understands the conditions of enrollment and is willing sign an informed consent form to participate in the study
排除标准
- •Subject had an SSI at the index level during the IDE study (NCT03123549) or the PAS (NCT04980378)
- •Subject was withdrawn or withdrew consent to participate in the IDE study (NCT03123549) or PAS (NCT04980378)
结局指标
主要结局
Clinical Composite Success Rate
时间窗: 10 years
Individual success is defined as at least a 15 point improvement in Neck Disability Index (NDI) Score at 120 months compared with baseline, maintenance or improvement in neurologic status at 120 months compared with baseline, no additional surgical procedure at the index level within 120 months, and the absence of a serious adverse event classified as implant-associated or implant/surgical procedure-associated within 120 months. A subject must meet each criterion to be considered an overall study success. NDI scale is reported in a range from 0 - 100, with 0 consistent with best ability to function and 100 with worst ability to function.
次要结局
- Disc height at each annual timepoint will be compared to baseline(10 years)
- Range of motion (ROM) at each annual timepoint compared to baseline(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)
- Displacement or migration of the Simplify Disc at each annual timepoint will be compared to the post-op timepoint in the IDE study (NCT03123549)(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)
- Patient satisfaction and perceived effect at each annual timepoint(10 years)
- Motor status at each annual timepoint compared to baseline(10 years)
- SF-36® Health Survey at each annual timepoint compared to baseline(10 years)
- Percentage of subjects meeting the minimal clinically important difference (MCID) for NDI at each annual timepoint(10 years)
- Percentage of subjects meeting MCID for neck and arm pain questionnaire for each of the following pain locations: neck pain, arm pain, left arm pain, right arm pain.(10 years)
- Sensory status at each annual timepoint compared to baseline(10 years)