Feasibility of Patient-specific Titanium Mesh Via A Transantral Approach for Repair of Orbital Floor Fractures.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- enophthamus
研究概览
简要总结
The aim of the study is to evaluate the feasibility of CAD/CAM osteosynthesis mesh through a transantral surgical approach in the Repair of orbital floor fractures by means of clinical and radiographic findings.
详细描述
A CAD/CAM osteosynthesis mesh through a transantral approach should assumingly provide accurate reconstruction of the orbital volume and anatomy while eliminating the usual morbidity of lower eyelid approaches during orbital reconstruction.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with recent unilateral orbital floor fracture indicated for internal reconstruction -
- •(isolated or in combination with other facial fractures)
- •with existing or estimated enophthalmos based on radiographs and a contra-lateral healthy non-operated orbit.
排除标准
- •Delayed cases (more than 2 weeks)
- •previously operated cases
- •bilateral orbital floor fracture.
研究组 & 干预措施
orbital floor fracture
orbital floor fracture
干预措施: transantral orbital floor reconstruction by titanium mesh (Procedure)
结局指标
主要结局
enophthamus
时间窗: 6 months
will calculate the amount of alteration and quantity of Enophthalmos by mean of a Post-Op Soft window CT scan in mm
次要结局
未报告次要终点
研究者
Aliaa Khalaf Abd Ellatief Mohamed
principal investigator
Cairo University