A Prospective, Dual Canter, Double Armed, Open Label, Clinical Study to Evaluate the Performance of the PathKeeper System for Pedicle Screw Positioning in Spine Surgery
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Accuracy of the screw implantation by Gertzbein-Robbins scale
研究概览
简要总结
The goal of this is to evaluate performance of the Pathkeeper Surgical System. The main question[s]it aims to answer are: 1) evaluate pedicle screw position Participants will in compare Experimental arm: PathKeeper System (PKS) with control arm
详细描述
Trial design
- Allocation: Randomized
- Interventional Model: Parallel Assignment (double armed)
- Interventional Model Description: Dual center, prospective, randomized cohort study.
- Masking: None (Open Label)
- Primary Purpose: Treatment
- Enrolment: 32 (thirty-two) patients - 16 (sixteen) patients experimental and 16 control arms (100 screws each arm, estimated 20% of patients drop out).
Study arms
- Experimental arm: PathKeeper System (PKS) One to ten-level posterior, open, instrumented spine surgery using unilateral or bilateral pedicle screw instrumentation under PKS intraoperative navigation guidance.
Interventions: Medical Devise - PKS. The PKS spine navigation system is for spatial positioning and orientation of surgical instruments during pedicle screw implantation in patients undergoing posterior fixation in single or multiple levels. 2. Control arm: free-hand technique guided by intra-operative 2D Fluoroscopy One to ten-level posterior, open, instrumented spine surgery using unilateral or bilateral pedicle screw instrumentation under free-hand technique guided by intra-operative 2D fluoroscopy.
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
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and women
- •16 and above years old
- •Patients who are about to undergo open, instrumented spinal surgery
- •Signed informed consent form
排除标准
- •Men and women
- •16 and above years old
- •Patients who are about to undergo open, instrumented spinal surgery
- •Signed informed consent form
研究组 & 干预措施
Medical Device- PathKeeper System (PKS)
One to ten-level posterior, open, instrumented spine surgery using unilateral or bilateral pedicle screw instrumentation under PKS intraoperative navigation guidance.
Intervention: Medical Device - PKS. The PKS spine navigation system is for spatial positioning and orientation of surgical instruments during pedicle screw instrumentation in patients undergoing posterior fusion in single or multiple levels.
干预措施: Medical Device - PKS (Device)
2D Fluoroscopy
Control arm: Standard of care - free-hand technique guided by intra-operative 2D Fluoroscopy One to ten-level posterior, open, instrumented spine surgery using unilateral or bilateral pedicle screw instrumentation under free-hand technique guided by intra-operative 2D fluoroscopy
干预措施: Medical Device - PKS (Device)
结局指标
主要结局
Accuracy of the screw implantation by Gertzbein-Robbins scale
时间窗: Post-operative CT scan to be performed before hospital discharge and evaluation can be done right after or at the end of the of the data collection
Mean and STD of Gertzbein-Robbins classification scale based on a low-dose post-operative CT scan
次要结局
- Evaluate time-per-screw for the experimental device arm (PKS) arm.(Values to be collected during each surgery once the last screw insertion is completed (1-2 hours within the surgery))
- Evaluate radiation exposure dose and time in the operating room during the procedure in each study arm and comparatively.(24 hours after surgery)