NCT01439464Unknown不适用
Clinical Efficacy and Safety of Bioactive Glass-ceramic Intervertebral Spacer (Bonglass-SS) in Posterior Lumbar Interbody Fusion and, Titanium Cage Controlled, 1-year, Single-Blind, Non-Inferiority Trial
BioAlpha Inc.4 个研究点 分布在 1 个国家目标入组 86 人开始时间: 2010年10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
- 86
- 试验地点
- 4
- 主要终点
- Radiographic assessments of fusion and instability at 12 months after surgery
研究概览
简要总结
The goal of this study is to compare Bonglass-SS with titanum cage.
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
- Single (Participant)
入排标准
- 年龄范围
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •30~80 aged patients needed single-level posterior Interbody fusion at L1~S1
- •A subject who provided written informed consent to participate in this study
排除标准
- •Patitents with BMD T-score < -3.0
- •Women who are pregnant or plan to be pregnant within 3 years
- •Patient with malignant tumor
结局指标
主要结局
Radiographic assessments of fusion and instability at 12 months after surgery
时间窗: 12 months
次要结局
- CT assessments of fusion at 12 months after surgery(12 months)
研究者
研究点 (4)
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