Study to Investigate the Long Term Survivorship of Coflex CT Study: Sub-Analysis of 24 Month Spinous Process Fractures Via Post-60 Month CT Scan
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 主要终点
- Number of Participants With Radiographic Analysis of Evidence of Fracture or Healing Based on CT Scan
研究概览
简要总结
Examine the long-term survivorship via CT Scan of the coflex in patients who presented with spinous process fracture(s) at 24 months in the Paradigm Spine coflex IDE Study.
详细描述
This is a prospective, multi-center, single-arm, radiographic evaluation of all coflex IDE patients who presented with a spinous process fracture at 24 months as identified by independent radiographic review (using X-ray or CT). All patients were enrolled and followed through 60 months under the IDE and extended follow-up protocol.
The specific objective of this CT Study is to perform a sub-analysis of the patients with 24 month spinous process fracture(s) via a CT scan at post-60 months. A CT Scan will be performed and analyzed by an independent radiographic review lab for evidence of fracture or healing at the long term timepoint.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- •Participant in coflex IDE Study
- •Willing and able to give informed consent
- •Spinous process fracture identified by site and/or radiographic lab at 24 months
排除标准
- •Subjects who died, were withdrawn or withdrew consent to participate in the study
- •Subjects who are pregnant, or planning to become pregnant, during the course of this study
- •Subjects who have cancer, whether active or in remission
结局指标
主要结局
Number of Participants With Radiographic Analysis of Evidence of Fracture or Healing Based on CT Scan
时间窗: Post-60 Months
Any coflex patients with radiographic observations of spinous process fracture at post-24 months, will be examined via CT at 5 years for evidence of fracture or of healing.
次要结局
未报告次要终点