Application of 3-Dimensional Printing Guide Template and Pointed Lotus-style Regulator in Percutaneous Pedicle Screw Fixation for Thoracolumbar Fractures
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- First puncture success rate,number of insertions before reaching the desired position, number of fluoroscopy before reaching the desired position, radiation dosage before reaching the desired position, operation time before reaching the desired position
研究概览
简要总结
This study aims to analysis the efficacy of the 3D printing percutaneous guide template in combination with the pointed lotus-style regulator in percutaneous pedicle screw fixation.
详细描述
All thoracolumbar fractures patients receiving percutaneous pedicle screw fixation (PPSF) were enrolled and randomly divided into 3 groups. Patients in Group A received traditional PPSF, while patients in Group B received PPSF with flat end lotus-style regulator and patients in Group C received PPSF with pointed lotus-style regulator.
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 (Participant)
入排标准
- 年龄范围
- 50 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The thoracolumbar vertebral compression fracture which the injury time is less than 7 days
- •The vertebral fracture sites where are located in T11-L2
- •No clinical neurological symptoms and signs
- •The patients who have complete preoperative X-ray, CT, MRI and other imaging data
排除标准
- •Vertebral burst fracture with spinal canal occupation
- •Fracture caused by severe osteoporosis or tumor and other pathological factors
- •Moderate and severe scoliosis
- •Patients with pedicle dysplasia
- •Patients with severe heart, liver and kidney diseases, diabetes, immune diseases, mental diseases who cannot tolerate surgery
- •Coagulation dysfunction or surgical site of the skin infection
结局指标
主要结局
First puncture success rate,number of insertions before reaching the desired position, number of fluoroscopy before reaching the desired position, radiation dosage before reaching the desired position, operation time before reaching the desired position
时间窗: twenty months
All the operations were successfully completed. The number of pedicles successfully first pierced in group C was higher than that in group A and group B (P\<0.05);The number of insertion, fluoroscopy and operation time before the insertion needle reached the ideal position, the total number and time of intraoperative fluoroscopy, and the intraoperative blood loss in group C were all significantly lower than those of group A and group B (P\<0.05)
VAS scores after surgery
时间窗: twenty-two months
All patients were followed up 6 months after surgery. VAS scores at 1 day and 7 days after surgery were higher in Group A than those in other groups（P\<0.05）, but no differences were found VAS scores at 1 , 3 and 6 months after surgery in 3 groups.Specific methods: drawing a 10cm line on the paper, one end of the horizontal line is 0, that is painless; The other end is 10, which means severe pain; The intermediate part indicates different levels of pain. Asking the patient to mark the level of pain on a horizontal line according to how he or she feels. 0-2: meaning comfortable; 3-4: slight discomfort; 5-6: moderate discomfort; 7-8: Severe discomfort;9-10: Extreme discomfort.
次要结局
未报告次要终点
研究者
Ming Zhang
medium-grade professional title
The Second People's Hospital of Huai'an