A Prospective Study of Early Mobilisation in the Surgical Robot Assisted Spinal Surgery
试验速览
- 阶段
- 不适用
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Visual Analogue Scale
研究概览
简要总结
In this study, patients who underwent lumbar spine surgery in our hospital were included. A prospective study was conducted to investigate the effects of early mobilisation on postoperative complications, functual outcomes and patient satisfaction after robotic assisted lumbar spinal surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •diagnosis of degenerative diseases or spinal fracture
- •single level instrumentation sugery
- •sign informed consent
排除标准
- •multilevel instrumentaion surgery
- •diagnosis of severe osteoperosis (BMD < 60mg/cm3) by QCT
- •coagulant function abnormality
- •severe internal disease
- •not suitable for inclusion
结局指标
主要结局
Visual Analogue Scale
时间窗: 3 months postoepratively
Low back pain and leg pain is an important sign and a frequent patient complaint. The VAS pain scoring standard (scores from 0 to 10) was as following: 0 means painless; 1-3 means mild pain that the patient could endure; 4-6 means patient was in pain that could be endured and be able to sleep; and 7-10 means patient had intense pain and was unable to tolerate the pain.
次要结局
- Oswestry Disability Index(3 months postoperatively)
- Japanese Orthopedic Association(3 months postoperatively)
研究者
Wei Tian
director of spine department
Beijing Jishuitan Hospital