Prospective Monocentric Randomized Study Comparing Arthrodesis Technique of Thoracic and/or Lumbar Spine by Posterior Approach Performed by Robot-assisted Surgery (Robot Mazor X Stealth ™) Versus Conventional Surgery
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Evaluation of screw placement by a CT scan
研究概览
简要总结
Osteosynthesis by pedicle screwing is the reference technique since the 1980s, due to the quality of the mechanical grip of the screw in the pedicle, despite difficulties of placing the implant in this narrow tunnel.
This precision was improved by fluoroscopy, then by navigation, which made it possible to reduce the extra-pedicular placement of the screws and consequently the complications.
Since the 2000s, robotic has been developed in all areas, including medicine and surgery, (Da Vinci robot in urology) and several robots are currently marketed for spinal surgery, Medtronic's Mazor X Stealth ™ robot being the most successful.
The aim of this study is to evaluate on a prospective randomized comparative study the quality of the placement of the screws as well as the occurrence of complications, the clinical results and the medico-economic interest that robotic surgery can bring.
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
- None
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
- •Male, female, over 18 years old,
- •Any patient operated for thoracic and/or lumbar spine arthrodesis (spondylolisthesis, asymmetric disc disease, spinal instability, spinal deformities, advanced disc disease),
- •Patient having given his free, informed and written consent to participate in the study,
- •Patient able to answer questionnaires, able to communicate in the language of the country of the study,
- •Negative pregnancy test,
- •Patient affiliated to a social security scheme or beneficiary of such a scheme.
排除标准
- •Psychological disorders,
- •Addiction to analgesics,
- •Chronic infection,
- •History of instrumented lumbar surgery,
- •BMI greater than or equal to 40kg/m²,
- •Pregnant or breastfeeding woman,
- •Patient participating in another clinical study,
- •Protected patient: adult under guardianship, curatorship or other legal protection, deprived of freedom by judicial or administrative decision.
研究组 & 干预措施
Robot assisted surgery
Patient operated for thoracic and/or lumbar spine arthrodesis with robot assistance Mazor
干预措施: Computerised tomography (Procedure)
Conventional surgery
Patient operated for thoracic and/or lumbar spine arthrodesis with conventional surgery
干预措施: Computerised tomography (Procedure)
结局指标
主要结局
Evaluation of screw placement by a CT scan
时间窗: one day
Screws placement will be evaluated for each patient by a CT scan on D1 post-intervention. The evaluation of the placement of the screws (reading of the CT images) will be carried out by 2 radiologists independent of the surgical team, blinded to the technique used for the placement of the screws (robot-assisted/conventional surgery). In case of disagreement between the 2 evaluators, a 3rd evaluator will be requested.
次要结局
未报告次要终点