Does Intraoperative 3D Fluoroscopy Accurately Assess Syndesmotic Reduction Following Traumatic Ankle Injury?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Number of Participants for Which the Surgeon Changed Reduction of Syndesmotic Reduction Because of Information Provided by 3D Fluoroscopy
研究概览
简要总结
The purpose of this study is to determine if use of new imaging technology termed "3D fluoroscopy" will lead the surgeon to change the position of the fractured bones to a more accurate position.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Skeletally mature
- •Patients with unilateral, acute, displaced ankle fractures with preoperative evidence of syndesmotic disruption or intraoperative evidence of syndesmotic instability following malleolar fixation.
排除标准
- •Patients skeletally immature;
- •Patients less than age 18 years and more than age 75;
- •Patients with previous ankle trauma to either ankle;
- •Patients with bilateral ankle injuries;
- •Patients with previous osseous injuries to the tibia or fibula; and
- •Patients with isolated syndesmotic injury and no fracture (i.e. high ankle sprains)
研究组 & 干预措施
2D Fluoroscopy then 3D Fluoroscopy
Patients with syndesmotic instability will undergo reduction of the syndesmosis followed by provisional fixation with a clamp or Kirshner wire. The reduction quality will be initially compared to the contralateral ankle mortise and talar-dome lateral radiographs using the technique of Summers et al (2D Fluoroscopy). After the attending surgeon is satisfied with the reduction quality, 3D fluoroscopy will be used to generate additional images to assess syndesmotic and fibular reductions. Both 2D and 3D Fluoroscopy will be performed using device "Ziehm Vision RFD 3D image-intensified fluoroscopic x-ray system".
干预措施: 2D Fluoroscopy (Device)
2D Fluoroscopy then 3D Fluoroscopy
Patients with syndesmotic instability will undergo reduction of the syndesmosis followed by provisional fixation with a clamp or Kirshner wire. The reduction quality will be initially compared to the contralateral ankle mortise and talar-dome lateral radiographs using the technique of Summers et al (2D Fluoroscopy). After the attending surgeon is satisfied with the reduction quality, 3D fluoroscopy will be used to generate additional images to assess syndesmotic and fibular reductions. Both 2D and 3D Fluoroscopy will be performed using device "Ziehm Vision RFD 3D image-intensified fluoroscopic x-ray system".
干预措施: 3D Fluoroscopy (Device)
结局指标
主要结局
Number of Participants for Which the Surgeon Changed Reduction of Syndesmotic Reduction Because of Information Provided by 3D Fluoroscopy
时间窗: Immediately at the time of 3D Fluoroscopy
Patients with syndesmotic instability will undergo reduction of the syndesmosis followed by provisional fixation with a clamp or Kirshner wire. The reduction quality will be initially compared to the contralateral ankle mortise and talar-dome lateral radiographs using the technique of Summers (2D Fluoroscopy). After the attending surgeon is satisfied with the reduction quality, 3D fluoroscopy will be used to generate additional images to assess syndesmotic reductions.
次要结局
- Alignment as Assessed by the AOFAS Score(6 months after 3D Fluoroscopy)
- Pain as Assessed by the PROMIS Score(6 months after 3D Fluoroscopy)
- Number of Participants With Syndesmotic Malreduction as Assessed by a Single Postoperative Bilateral CT Scan(1 day after 3D Fluoroscopy)
- Function as Assessed by the PROMIS Score(6 months after 3D Fluoroscopy)
- Number of Participants for Which the Surgeon Changed Reduction of Fibular Fracture Reduction Because of Information Provided by 3D Fluoroscopy(Immediately at the time of 3D Fluoroscopy)
- Pain as Assessed by the AOFAS Score(6 months after 3D Fluoroscopy)
- Function as Assessed by the AOFAS Score(6 months after 3D Fluoroscopy)
研究者
Joshua L Gary
Associate Professor
The University of Texas Health Science Center, Houston