NCT03509389Unknown不适用
The Prone XLIF. An Observational Pilot Study Based on Prospective Study
I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2018年4月7日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Complication rate
研究概览
简要总结
Observational prospective study to evaluate the feasibility, effectiveness and the rate of complications of the XLIF (Extreme Lateral Interbody Fusion) performed in prone position to treat spinal diseases of the lumbar region.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients suffering from lumbar spinal disease that requires a circumferential fusion
- •Patients suitable to undergo spinal fusion with an XLIF technique (according to the label indication/contraindications)
- •Patients who are willing and able to provide written informed consent to surgery and study
排除标准
- •a congenital or post-traumatic vertebral abnormality at the target level
- •patients with a previous abdominal retroperitoneal surgery
- •patients that refuses/not suitable to undergo a XLIF surgery in prone position
- •subjects that are unable to provide a written informed consent to surgery and study
- •subjects that are unable to will or intend
- •pregnant women (declared before surgery)
结局指标
主要结局
Complication rate
时间窗: intraoperative
Registration of intraoperative complications during surgery
次要结局
- Visual Analogic Score (VAS) leg and back(in 5 days from surgery - 6 months follow-up)
- Oswestry Disability Index(in 5 days from surgery - 6 months follow-up)
- Length of surgery(intraoperative)
- Subsidence rate(in 5 days from surgery)
研究者
研究点 (1)
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