NCT01764906Unknown不适用
The Clinical Study to Evaluate the Efficacy and Safety of Novosis in Posterolateral Fusion
BioAlpha Inc.1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2013年3月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Fusion grade by CT assessments after surgery
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of Novosis in posterolateral fusion
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18~80 aged patients needed single-level posterolateral fusion at L1~S1
- •A subject who provided written informed consent to participate in this study
排除标准
- •Patients with BMD T-score < -3.0
- •Women who are pregnant or plan to be pregnant within study period
结局指标
主要结局
Fusion grade by CT assessments after surgery
时间窗: 24 weeks
次要结局
- Fusion grade by Radiographic assessments after surgery(24 weeks)
研究者
研究点 (1)
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