Evaluation of the Accuracy of the eCential Robotics Robot in Spinal Surgery at Amiens Picardie University Hospital
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Pedicle Screw accuracy using the traditional Gertzbein-Robbins Scale
研究概览
简要总结
Spinal surgery has evolved considerably over the years, and the introduction of advanced technologies has played a crucial role in improving clinical outcomes. The use of surgical robots, such as the eCential Robotic system, has emerged as an innovative solution for optimizing the precision and safety of procedures, particularly the placement of pedicle screws in the spine.
The eCential Robotics surgical robot offers several advantages for the placement of pedicle screws in the spine. Various studies have demonstrated a significant improvement in screw accuracy and stability, reducing revision surgery rates with surgical robots. The system enables advanced preoperative planning based on three-dimensional imaging, improving understanding of the patient's specific anatomy. This study will also provide a clinical basis for the CE marking process.
The objective of this prospective study is to collect data confirming safety, performance and clinical benefits of the eCential Robotics robot when used during spine and pelvic surgeries.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 5 years or older.
- •Treated at CHU Amiens Picardie for spinal surgery requiring implantation of pedicle screws.
- •Informed consent signed by patient or legal representative and child.
- •Membership of a social security scheme.
- •Negative pregnancy test for adolescent women of childbearing age
排除标准
- •Patient managed by a practitioner with no experience of the eCential Robotics robot.
- •Patient requiring a technique without implantation of pedicle screws.
- •Patients already suffering from deterministic radiation effects
- •Pregnant, parturient or breast-feeding women.
- •Patients under guardianship or curators, under safeguard of justice or deprived under public law.
结局指标
主要结局
Pedicle Screw accuracy using the traditional Gertzbein-Robbins Scale
时间窗: 12 months
Pedicle Screw accuracy using the traditional Gertzbein-Robbins Scale. perfect intra-pedicular localization without any cortical breach (Grade A) * \< 2 mm pedicle breach (Grade B) * \< 4 mm pedicle breach (Grade C) * \< 6 mm pedicle breach (Grade D) * ≥ 6 mm pedicle breach (Grade E) Screws graded A and B are clinically acceptable, screws graded C, D, E have a significant deviation from the intended trajectory.
次要结局
- Per-operative Complication(day 0)
- Immediate post-operative Discharge time (days)(up to 12 months)
- Immediate post-operative Length of hospital stay (days)(up to 12 months)
- Per-operative Hardware or software malfunction(day 0)
- Per-operative Intraoperative complication(day 0)
- Immediate post-operative Adverse events(up to 12 months)
- 9-month follow-up Adverse events(at 9 months)
- Per-operative Blood loss (ml)(day 0)
- Per-operative Operative time (min)(day 0)
- Per-operative X-ray exposure dose (mGy.cm2)(day 0)