NCT02504242Unknown3 期
A Multi-center, Comparative Clinical Trial to Evaluate the Efficacy and Safety of Inject BMP in Patients Undergoing Transforaminal Lumbar Interbody Fusion
BioAlpha Inc.0 个研究点目标入组 128 人开始时间: 2015年4月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 128
- 主要终点
- Bone Fusion With CT and Dynamic radiographs(X-ray)(post operative 48 weeks)
研究概览
简要总结
A Randomized, Subject-Assessor Blind, Multi-center, Comparative Clinical Trial to evaluate the efficacy and safety of Inject BMP in Patients Undergoing Transforaminal Lumbar Interbody 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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subject needs the infusion between the first lumbar vertebrato and the first ilium from those who require posterior spinal instrumentation and interbody fusion for the following reasons,
- •Spinal stenosis
- •Spinal disc herniation requiring broad laminectomy
- •Spondylolisthesis or spondylolysis
- •Recurrent herniated disc
排除标准
- •Patients with BMD T-score < -3.0
- •Women who are pregnant or plan to be pregnant within study period
研究组 & 干预措施
Inject BMP
Experimental
ExcelOS Inject / rhBMP-2
干预措施: Inject BMP (Device)
Locally Harvested Bone
Active Comparator
Locally Harvested Bone
干预措施: Locally Harvested Bone (Procedure)
结局指标
主要结局
Bone Fusion With CT and Dynamic radiographs(X-ray)(post operative 48 weeks)
时间窗: at 48 weeks after surgery
次要结局
未报告次要终点
研究者
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