Artificial Intelligence Versus Manual Planning in Patients Undergoing Robot-assisted Pedicle Screw Internal Fixation: a Prospective Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 主要终点
- The accuracy of screw positioning or placement
研究概览
简要总结
The goal of this clinical trial is to learn if the artificial intelligence technology helps to improve the efficiency in robot assited spinal surgery. The main questions it aims to answer are:
Does the AI technology shorter the mannual planning time of screw trajectories？ Does the AI technology affect the surgical accuracy？ Researchers will compare the artificial intelligence technology to the conventional mannual planning in robotic surgery.
Participants who met inclusion criteria and do not have any exclusion criterion will be randomized to artificial intelligence or mannual planning group.
详细描述
Study design:
multicenter, non-inferiority, open-label, randomized controlled trial in patients undergoing robotic spinal surgery.
Monitoring:
Monitoring of patient's safety and effectiveness data is performed by a designated independent Data Safety and Monitoring Board (DSMB). The DSMB watches over the ethics of conducting the study in accordance with the Declaration of Helsinki.
Sample Size Calculation:
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
- 是
入选标准
- •Admission to one of the participating centers；
- •Need for and start of robotic spinal surgery
- •Patients had complete medical records and imaging data;
排除标准
- •Age less than 18 years;
- •Patients with severe comorbidities;
- •Patients diagnosed with tumor diseases;
- •Inability to carry out the intervention (mental of physical conditions that limited participation);
- •Patients with morbid obesity (body mass index > 40);
- •Missing medical records and imaging data;
- •Patients with suspected or confirmed pregnancy;
- •Patients participating in another RCT with the same clinical endpoint, or interventions possibly compromising the primary outcome;
- •No informed consent.
结局指标
主要结局
The accuracy of screw positioning or placement
时间窗: 1 month
according to the Gertzbein and Robbins scale, including grade A (screw was completely within the pedicle), grade B (pedicle cortical breach \<2 mm), grade C (pedicle cortical breach \<4 mm), grade D (pedicle cortical breach \<6 mm), and grade E (pedicle cortical breach \>6 mm). Grade A + B were considered clinically acceptable. The percentage of clinically acceptable screws was recorded.
次要结局
- The planning time(1 day)
- postoperative complication(3 month)