Prospective Robotic-Guided Registry of Spine Surgery
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- To evaluate the success of robotic-guided spine surgery, by screw placement accuracy.
研究概览
简要总结
This study aims to combine multi-center data of robotic assisted spine surgery, to evaluate the true scope of this advancing technology.
详细描述
What is the impact on clinical and patient-reported outcomes for participants who undergo robot assisted surgery? This will be the first multi-center study to prospectively collect data on robotic assisted spine surgery outcomes. The primary objective of this study will be to facilitate quantification of potential short- and long-term benefits of robotically guided spine surgeries.
It is hypothesized that use of robotic guidance during spinal instrumentation will have numerous short- and long-term benefits to both participant and surgeon. Expected benefits include improved surgical and clinical outcomes, lower incidence of procedure-related adverse events (e.g., fewer new neurological deficits, implant-related durotomies, and implant misplacements), improved implant accuracy, lower intraoperative radiation exposure, and lower reoperation rates, when compared to the published literature.
The secondary objective of this study is to assess the clinical performance of robotic instrumentation as per the pre-operative plan. To this end, data on a number of common clinical metrics will be analyzed to determine the extent to which they are affected by the use of robotic guidance during implantation.
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
- 12 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any pediatric, adolescent or adult patient
- •Undergoing open or MIS robotic-guided spine surgery using the Mazor Core Technology.
排除标准
- •Pregnancy
- •active infection
- •malignancy
- •primary abnormalities of bone
- •primary muscle diseases (e.g., muscular dystrophy)
- •neurologic diseases
- •spinal cord abnormalities/lesions
- •paraplegia.
结局指标
主要结局
To evaluate the success of robotic-guided spine surgery, by screw placement accuracy.
时间窗: 1 year after surgery
To determine screw accuracy
To evaluate the success of robotic-guided spine surgery, from planning to execution.
时间窗: 1 year after surgery
To evaluate the success from planning to execution of robotic screw placement.
To evaluate the success of robotic-guided spine surgery, by revision surgery rates.
时间窗: 1 year after surgery
To determine the rate of revision surgery due to symptomatic screw malposition within 1 year
To evaluate the success of robotic-guided spine surgery, by the radiation exposure.
时间窗: 1 year after surgery
To determine radiation exposure to the patient and surgeon.
次要结局
- To evaluate clinical outcomes, by patient disability rating(1 year after surgery)
- To evaluate clinical outcomes, as determined by all cause revisions(1 year after surgery)
- To evaluate clinical outcomes, by surgical complications(1 year after surgery)
- To evaluate clinical outcomes, by patient reported outcome measures(1 year after surgery)