Adequacy of One-Point Fixation of Displaced Zygomatic Complex Fractures Using a Customized Plate pre_post Study
试验速览
- 阶段
- 不适用
- 入组人数
- 18
- 主要终点
- Patient satisfaction. Measuring device visual analogue scale. Measuring unit 0-10
研究概览
简要总结
Patients with unilateral non-comminuted zygomatic complex fracture undergo fixation of the complex by a customized plate at one point after 3D virtual simulation and reduction of the complex using Mimics software.
详细描述
History data will be gathered including personal data, medical and surgical history, and family history.
Clinical examination and photographic records will be carried out to evaluate the magnitude and direction of the displaced zygoma, degree of facial asymmetry, neurosensory affection and functional disturbances.
Computed tomography (CT) scan:
Patients will receive a preoperative computed tomography (CT) scan of the facial bones [ Axial cuts, DICOM file, Gantry tilt zero and minimal thickness of 1 mm]. The radiographic data will be imported into a surgical simulation software to virtually reduce the fractured zygoma and custom design the plate for fixation.
General operative procedures:
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
- 15 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients' age range from 15-65 years.
- •Patients with unilateral zygomatic complex fracture
- •Displaced fracture
- •Dentulous or edentulous patients.
- •Patients should be free from any systemic disease that may affect normal healing of bone and predictable outcome.
排除标准
- •. Patients with systemic diseases as history of radiation therapy or chemotherapy, hematological disorders, neuromotor disorders and autoimmune diseases (may affect normal healing).
- •Patients with comminuted fractures .
- •Delayed presentation 3 weeks or more after the date of trauma.
研究组 & 干预措施
Unilateral Non comminuted zygomatic complex fracture
Patient undergo treatment no control group
干预措施: Titinium (Device)
结局指标
主要结局
Patient satisfaction. Measuring device visual analogue scale. Measuring unit 0-10
时间窗: One week
Esthetics and function of patient return post operative. Normal
次要结局
- Adequacy of reduction compared to the preoperative virtual simulation measuring device mimics software Ware. Measuring unit millimeters(Immediately post operative)
研究者
Ahmed Ashour Saad Borma
Internal resident at Maxillofacial department
Cairo University