Randomized Comparative Trial of Minimally Invasive Robotic vs. Freehand in Short Adult Degenerative Spinal Fusion Surgeries
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Pedicle screw instrumentation accuracy
研究概览
简要总结
The purpose of this study was to quantify potential short- and long-term benefits of robotically-guided minimally invasive spine surgery in instrumentation of degenerative lumbar or lumbosacral spine disease in adult patients, in comparison to instrumentation in a matching cohort of control patients performed using conventional freehand technique.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 40 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients (age from 40 years to 85 years), undergoing short (below 3 consecutive vertebrae) lumbar or lumbosacral fixation surgery.
- •Primary surgery and revision surgery
- •Patient capable of complying with study requirements
- •Signed informed consent of patient or legal guardian
排除标准
- •Infection or malignancy
- •Primary abnormalities of bones (e.g. osteogenesis imperfecta)
- •Primary muscle diseases, such as muscular dystrophy
- •Neurologic diseases (e.g. Charcot-Marie Tooth, Guillain-Barre syndrome, cerebral palsy, neurofibroma)
- •Spinal cord abnormalities with any neurologic symptoms or signs
- •Spinal cord lesions requiring neurosurgical interventions, such as hydromyelia
- •Paraplegia
- •Patients requiring anterior release or instrumentation
- •Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study.
- •Patient cannot follow study protocol, for any reason
- •Patient (or legal guardian, when applicable) cannot or will not sign informed consent
研究组 & 干预措施
Robot assisted pedicle screw fixation
posterior lumbar interbody fusion using Robot assisted pedicle screw fixation (Renaissance, Mazor Robotics Ltd, Caesare, Israel)
干预措施: Renaissance, Mazor Robotics Ltd, Caesare, Israel (Device)
Free hand technique
using Free hand technique, posterior lumbar interbody fusion (No specific device)
干预措施: free hand technique (Procedure)
结局指标
主要结局
Pedicle screw instrumentation accuracy
时间窗: within 7 days after operation
The location of pedicle screw is evaluated by postoperative CTs in a subset of patients
Oswestry Disability Index
时间窗: up to 5 year after operation, every year
Health status
次要结局
- Radiographic adjacent level degeneration(up to 5 year after operation, every year)
- postoperative drainage(within 3 days after operation)
- time to ambulation(within 3 days after operation)
- SF-36(up to 5 year after operation, every year)
- Fusion rates(up to 5 year after operation)
- Operation duration(After operation)
- intraoperative blood loss(after operation)
- amount of transfusion(within 7 days after operation)
- Visual Analog Pain Scale(up to 5 year after operation, every year)
- Change of Oswestry Disability Index(up to 5 year after surgery, every year)
研究者
Jin S. Yeom
Professor
Seoul National University Hospital