NCT05101057Unknown不适用
A Retrospective Study to Examine the Effect of Adjuvant Combined Magnetic Field Stimulation on Primary Anterior Cervical Discectomy and Fusion (ACDF) Patients
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- Time to fusion
研究概览
简要总结
A retrospective parallel group comparison study to support expansion of the indication of the company's FDA approved Spinalogic™ device to include the cervical spine. The SpinalogicTM device was initially approved by FDA as an adjunct to one- or two-level lumbar fusion (P910066/S011). It is a non-invasive bone growth stimulator (BGS) that generates a combined magnetic field (CMF) that has been proven to accelerate bone healing and fusion in the lumbar spine.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Time to fusion
时间窗: 12 months
Comparison of the cervical fusion rate between treated and control group patients
次要结局
- Patient Reported Outcome Measures VAS(12 months)
- Patient Reported Outcome Measures NDI(12 months)
- Patient Reported Outcome Measures OC(12 months)
研究者
研究点 (2)
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