The Difference of Two and Three Fluoroscopic Views of Sacrum for Percutaneous Sacroiliac Screw Insertion in High Energy Posterior Pelvic Ring Injured Patients, a Double-blinded Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Operative time
研究概览
简要总结
The goal of this clinical trial is to learn about the surgical techniques of percutaneous sacroiliac screw fixation both the two-view fluoroscopic technique (sacral inlet and outlet views) and the standard three-view fluoroscopic technique (lateral, sacral inlet, and sacral outlet views).
The main questions it aims to answer is:
• Is there any difference of the operative time, intraoperative radiation exposure time, screw malposition rate, and postoperative neurological complication rate for percutaneous pelvic screw fixation between two techniques?
Researchers will compare two surgical techniques of percutaneous sacroiliac screw fixation in high energy posterior pelvic ring injured patients.
Participants will:
- Be examined neurological status carefully before and after the operation
- Get both preoperative and postoperative CT scan
- Undergo the percutaneous sacroiliac screw(s) fixation with or without anterior plating fixation
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with traumatic posterior pelvic ring or sacral fractures indicated percutaneous screw fixation.
- •Patients who are fully conscious, possess decision-making capacity, and can provide informed consent.
排除标准
- •Presence of severe sacral dysmorphism (sacral dysmorphic score > 70 and absence of osseous corridor)
- •Concomitant diagnosis of osteoporosis or age more than 60 years
- •Age under 20 years or evidence of skeletal immaturity
- •Highly comminuted sacral fractures precluding accurate intraoperative assessment of the screw trajectory
- •Pre-existing lumbosacral neurological deficits prior to surgery
- •Withdrawal Criteria:
- •Intraoperative necessity to convert to an alternative surgical method (e.g., inability to safely proceed with percutaneous fixation).
- •Absence of postoperative computed tomography (CT) scan
- •Loss to follow-up within 2 months postoperatively
研究组 & 干预措施
Percutaneous SI screw insertion using two fluoroscopic views
Patients with posterior pelvic ring or sacral injuries resulting from high-energy trauma who required the sacroiliac screw fixation.
Surgeon will insert the SI screw percutaneously using sacral inlet and sacral outlet fluoroscopic views
干预措施: Percutaneous sacroiliac screw fixation using two or three fluoroscopic views (Procedure)
Percutaneous SI screw insertion using three fluoroscopic views
Patients with posterior pelvic ring or sacral injuries resulting from high-energy trauma who required the sacroiliac screw fixation.
Surgeon will insert the SI screw percutaneously using lateral, sacral inlet and sacral outlet fluoroscopic views
干预措施: Percutaneous sacroiliac screw fixation using two or three fluoroscopic views (Procedure)
结局指标
主要结局
Operative time
时间窗: perioperative record
Operative time in minutes that takes for insertion of guide pin of cannulated SI screw; From the time of skin incision to the final acceptable positioning of the guide pin (prior to screw insertion)
次要结局
- Radiation Exposure Time(Perioperative record)
- Neurological complications by physical examinations and symptoms(Immediate postoperative to two months after operation)
- Screw malposition(Two months after operation, Postoperative CT scan will be evaluated for screw position.)