Assessment of the Feasibility of Using a Preoperative Surgical Fracture Analysis Tool
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Feasibility of incorporating the preoperative software plan based on surgeon's feedback
研究概览
简要总结
This study aims to evaluate a preoperative fracture analysis tool that uses 3D visualization and biomechanical modeling to assist surgeons in planning screw and plate fixation for complex tibial plateau fractures. By simulating different fixation strategies based on patient-specific CT data, the tool provides insights into construct stability, potentially improving surgical precision and reducing intraoperative uncertainty. The study also investigates the tool's feasibility within current clinical workflows without altering the standard of care.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age above 18
- •lower extremity fracture
排除标准
- 未提供
研究组 & 干预措施
3D Analysis Group
干预措施: 3D Fracture Analysis Tool (Device)
结局指标
主要结局
Feasibility of incorporating the preoperative software plan based on surgeon's feedback
时间窗: From enrollment to day after surgery
Surgeons will fill out a questionnaire after the surgery to assess the clinical feasibility of the analysis tool.
次要结局
未报告次要终点
研究者
Derek S. Stenquist, MD
MD
Massachusetts General Hospital