A Multicenter Randomized Controlled Clinical Investigation to Investigate the Treatment of Double (Bilateral) Mandibular Fractures
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 314
- 试验地点
- 13
- 主要终点
- Number of anticipated procedure- or condition-related Adverse Events
研究概览
简要总结
Mandibular fractures represent approximately 50% of the total facial fractures and are commonly (more than half) presented in more than one location. A few simple fractures can be treated using a conservative approach. More often, however, mandibular fractures require stabilization using open reduction and internal fixation.
Simple mandibular fractures can be treated using non-rigid fixation techniques that rely on the load-sharing principle, by which stabilization is accomplished with both fixation devices and bone surfaces. On the other hand, more complex fractures with continuity defects or comminuted need to be handle using rigid fixation where the device assumes all the forces (load-bearing principle). These approaches are well established, whereas the level of evidence for the treatment of bilateral double mandibular fractures (DMF) is still scarce. In fact, which surgical treatment, or combination of treatments, leads to the best outcome and the lowest rate of complications in bilateral DMFs is an open question.
The purpose of this study is to assess the complication rate in patients suffering from bilateral DMF treated either using non-rigid fixation on both fracture sides or a combination of rigid fixation on one side and non-rigid fixation on the other side.
详细描述
Prospective data will be collected in 314 patients suffering from bilateral (double) mandibular fracture randomly treated either with non-rigid fixation on both fracture sides or a combination of rigid fixation on one side and non-rigid fixation on the other side. This is a study where patients will be treated per randomization to one of the two established treatments and followed for further clinical examination post-operatively at 6 weeks and 3 months after the intervention.
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
- •Age 18 years or older at the date of the surgery
- •Diagnosis of bilateral (double) mandibular fracture located in:
- •Angle and body or
- •Angle and symphysis or
- •Body and symphysis
- •Dentition: Patients must have most of their maxillary and mandibular teeth present and it must be possible to identify proper occlusion. The application of intraoperative Mandibulo-maxillary fixation (MMF) using arch bars must be possible
- •Ability to understand the content of the patient information / Informed Consent Form
- •Willingness and ability to participate in the clinical investigation according to the Clinical Investigation Plan (CIP)
- •Signed and dated IRB/EC-approved written informed consent
排除标准
- •Fractures displaying continuity defect or comminution
- •Fractures showing clinical signs of infection at presentation
- •Edentulous mandible fracture
- •Fractures requiring an extra-oral surgical approach
- •Concomitant maxillary fractures
- •Concomitant condylar fracture
- •Prior surgical treatment of the mandibular fracture(s)
- •Atrophy of the mandible (<20 mm vertical height) at the level of the fracture(s)
- •Polytrauma (i.e. severe injuries leading to life-threatening condition)
- •Prisoners
- •Participation in any other medical device or medicinal product study within the previous month that could influence the results of the present study
结局指标
主要结局
Number of anticipated procedure- or condition-related Adverse Events
时间窗: 6 weeks
次要结局
- Location of the tooth with respect to the line of fracture(Pre-operatively (Day -1))
- Characteristics of the hardware(Intraoperatively (Day 0))
- Length of the hospital stay(Intraoperatively (Day 0))
- Difficulty of application of the hardware(Intraoperatively (Day 0))
- Mechanism of production of the fracture:(Pre-operatively (Day -1))
- Time in days between the occurrence of the injury and the surgery(Intraoperatively (Day 0))
- Degree of displacement of the fracture(Pre-operatively (Day -1))
- Length of the surgery(Intraoperatively (Day 0))
- Use of antibiotics(Intraoperatively (Day 0))
- Dysfunction of the mandible(6 weeks, 3 months)