NCT04176562招募中不适用
Prospective Study on Safety and Performance of Surgalign spINE Products
Xtant Medical12 个研究点 分布在 3 个国家目标入组 5,000 人开始时间: 2020年1月28日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 5,000
- 试验地点
- 12
- 主要终点
- Intervention Rates
研究概览
简要总结
This study is a prospective, multi-center, open label registry designed to collect real-world data on performance and safety data on RTI's spine products.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Candidate for RTI spine product.
- •Willing and able to consent to the study.
排除标准
- •Patient who is, or is expected to be inaccessible for follow-up.
- •Patient meets any exclusion criteria required by local law (e.g. age, mental capacity, etc.).
- •Other concurrent medical or other condition (chronic or acute in nature) that in the opinion of the investigator may prevent participation or otherwise render patient ineligible for the study.
结局指标
主要结局
Intervention Rates
时间窗: 1 month, 3 months, 6 months, 12 months, and 24 months
Rates of reoperation and/or revision procedures at index level
次要结局
- Disability (Cervical)(1 month, 3 months, 6 months, 12 months, and 24 months)
- Fusion(1 month, 3 months, 6 months, 12 months, and 24 months)
- Time to Intervention(1 month, 3 months, 6 months, 12 months, and 24 months)
- Radiographic Findings(1 month, 3 months, 6 months, 12 months, and 24 months)
- Adverse Events(1 month, 3 months, 6 months, 12 months, and 24 months)
- Disability (non-Cervical)(1 month, 3 months, 6 months, 12 months, and 24 months)
- Pain Change(1 month, 3 months, 6 months, 12 months, and 24 months)
研究者
研究点 (12)
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