Comparison of Operating Room Time Length With the Use of Virtual Surgical Planning Versus Conventional Treatment of Mandible Fractures
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- The Time Taken to Complete an Open Reduction Internal Fixation (ORIF)
研究概览
简要总结
The purpose of this trial is to compare operating room time between conventional treatment techniques [without Virtual surgical Planning (VSP)] versus treatment with use of Virtual surgical Planning (VSP) in patients that undergo mandibular reconstruction via open reduction internal fixation (ORIF).
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
- 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
- •Patient consent
- •Complex mandible fracture (at least two fractures) that require ORIF of at least one fracture. This will exclude condylar fractures
排除标准
- •Patient refusal to participate in study
- •Infected mandible fracture
- •Closed reduction treatment of mandible fracture
- •Fractures older than 2-3 weeks at the time of treatment
- •Other concomitant mid-facial bone fractures (ie, zygomaticomaxillary complex (ZMC), Lefort fractures)
- •Other etiologies than trauma of the mandibular fracture or pathologic fracture secondary to benign or malignant pathology that may require resection
- •Pregnant patients will NOT be excluded from the study
- •Co-morbidities (auto-immune disease, osteoporosis, titanium or metal allergy, uncontrolled diabetes (A1c greater than 8)
结局指标
主要结局
The Time Taken to Complete an Open Reduction Internal Fixation (ORIF)
时间窗: from start of ORIF to end of ORIF (about 2-3 hours)
The time taken to complete an Open Reduction Internal Fixation (ORIF) \[referred to as the "plating time"\] was defined as beginning after dissection was complete and fractures were initially reduced, and ending after all fracture sites were fixated with the final screw placed.
次要结局
- Number of Participants With Infections(6 weeks after ORIF)
- Type of Archbars Used in ORIF(from start of ORIF to end of ORIF (about 2-3 hours))
- Number of Participants Who Required Intraoperative Surgical Revisions(from start of ORIF to end of ORIF (about 2-3 hours))
- Number of Participants With Malocclusion(6 weeks after ORIF)
- Number of Participants With Fractures That Are Not Well Aligned(6 weeks after ORIF)
- Number of Participants Whose Occlusal Splint Fit Appropriately(from start of ORIF to end of ORIF (about 2-3 hours))
- Type of Surgical Approach to the Fracture Site(from start of ORIF to end of ORIF (about 2-3 hours))
- Distance of Maximal Interincisal Opening(6 weeks after ORIF)
- Number of Participants With Hardware Failure(from baseline to 6 weeks after ORIF)
研究者
Simon Young
Assistant Professor
The University of Texas Health Science Center, Houston