A Comparison of Pedicle Screws Placement Accuracy in Thoracolumbar Spine Using Two Guidance Techniques: O-arm Navigation and Cervical Distractor Screws
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Screw insertion time
研究概览
简要总结
Pedicle screw instrumentation is used nowadays mostly in spine fusion which is a surgical option for treating variety of conditions such as vertebral fractures, degenerative spine diseases, spine tumors and spine deformities. However, pedicle screws misplacement and breach may occur and be a great cause of morbidity. The breach rate can be as high as 20-39.8% but most of the time only small number is associated with complications. Surgeons use assistive technique to avoid screw breached and improve screw placement accuracy. Investigators aim in this study to compare accuracy of pedicle screws placement using two guidance techniques are O-arm navigation the latest assistive imaging technique that uses three-dimensional (3-D) real time images to allow the surgeons follow the screw's trajectory, and standard cervical distractor screws to mark the entry point and trajectory.
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
- Single (Outcomes Assessor)
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
- •Patients who need a thoracolumbar spine surgery that require pedicle screw insertion.
排除标准
- •Patients whose surgeries in cervical spine
- •Patients whose surgeries are for correction of deformities such as scoliosis and kyphosis, patients with infections or tumors.
结局指标
主要结局
Screw insertion time
时间窗: 5 hours
screw insertion time in each technique which will be assessed by calculating the total time from puncture at the entry point by awl to complete all screw insertions into pedicles divided by the number of pedicle screws
screws revision times
时间窗: 6 months
investigators will determine which group needs more screws revision
degree of screws breach
时间窗: 6 months
Investigators will determine degree of screws breach in the two comparison groups
Rate screws breach
时间窗: 6 months
Investigators will determine the rate of screws breach in the two comparison groups
次要结局
- complications(Up to 24 weeks)
- Direction of the breach(6 months)
