Evaluating Enhanced Metal Reduction Techniques for Definitive CT Scanning to Assess Spinal Fusion With Trabecular Metal Implants (TM-Ardis)
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- CT scan to determine if the study software can reduce metal scatter on the scan.
研究概览
简要总结
To determine if the subject metal reduction software helps to better visualize bone interphase and fusion reliability. Assess whether the appropriate procedural modification facilitates clearer images when implanted with a trabecular metal spinal implant
详细描述
To determine if the subject metal reduction software helps to better visualize bone interphase and fusion reliability, and assess whether the appropriate procedural modification facilitates clearer images when implanted with a trabecular metal spinal implant.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A signed informed consent.
- •Male or non-pregnant female scheduled for Trabecular Metal (TM - Ardis) implant, single level lumbar.
- •Participant must be at least 18 years of age.
排除标准
- •Patient is pregnant Patient is unable to comprehend the requirements of the study.
- •Patient is unable to undergo scanning (due to body habitus, inability to comply with positioning requirements, etc.).
结局指标
主要结局
CT scan to determine if the study software can reduce metal scatter on the scan.
时间窗: 6 month post operative
Each CT scan will be evaluated to asses if you can visualize fusion, bone interface, and/or device migration with an experimental metal reduction software for CT scan
次要结局
未报告次要终点