NCT02104167已完成不适用
An Open-Label Clinical Study of the Safety and Efficacy of the ROI-C Anterior Cervical Interbody Fusion Device Using the VerteBRIDGE Plating System
LDR Spine USA7 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2013年9月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 110
- 试验地点
- 7
- 主要终点
- Percentage of Participants With Fusion
研究概览
简要总结
The purpose of this combined retrospective and prospective clinical study is to examine the clinical outcomes of the ROI-C® anterior cervical interbody fusion device with VerteBRIDGE® plating to treat single level degenerative disc disease between C2 and T1 in the short term, with a focus on fusion rates.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject must have degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one level between C2 and T
- •The subject can have the ROI-C device at only one level.
- •Autograft must have been used with the ROI-C device.
- •Subject should have had a minimum of 6 (six) weeks of non-operative treatment prior to surgery.
- •Subject must be at least 21 years of age at the time of surgery
排除标准
- •No BMP was used in the interbody cage
- •Subject was a prisoner at the time of surgery
- •Subject was pregnant at the time of surgery
- •Subject had an active infection or sepsis at the time of surgery
结局指标
主要结局
Percentage of Participants With Fusion
时间窗: 12 months or more after device implantation; mean follow up 20.7 months
Rate of fusion using A/P, lateral, and flexion/extension radiographs at each time point; defined by the presence of bridging bone with less than 2° segmental motion in flexion/extension and less than 3mm of A/P translation.
次要结局
- Mean Neck Disability Index (NDI), Visual Analog Scale (VAS)- Neck Pain, Visual Analog Scale (VAS)-Right and Left Arm Pain(12 months (Last available visit) post surgery)
研究者
研究点 (7)
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