The Accuracy of Reconstruction of Orbital Walls Fracture Using Prebent Mesh Versus Patient Specific Implant : A Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- motility of eye
研究概览
简要总结
under GA, incision to access to orbital walls. Then insertion of prebent titanium mesh or customized titanium implant and fixation with miniscrews, examination of ocular motility using forced duction test followed by closure of flap.
详细描述
under GA, incision to access to orbital walls. complete reflection of orbital floor to be constructed then insertion of customized orbital implant of patient or insertion of titanium mrsh after adaption on the model and fixation with miniscrews, examination of ocular motility using forced duction test followed by closure of flap.
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
- Single (Participant)
盲法说明
patient select randomly from closed label
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •patient had fractured orbital walls suffering from enophthalmous, hypoglobus, diplopia
排除标准
- •systemic disease interfere with bone healing enophthamous less than 2 mm
研究组 & 干预措施
prebent titanium mesh
reconstruction of fractured orbital walls with perbent titanium mesh
干预措施: reconstruction of orbital walls (Device)
customized titanium implant (patient specific implant)
econstruction of fractured orbital walls with patient specific implant (customized titanium implant)
干预措施: reconstruction of orbital walls (Device)
结局指标
主要结局
motility of eye
时间窗: one month
using 9 gaze test to evaluate motility of eye
restoring the accurate position of eye
时间窗: one month- six months
using exophthalmometer to measure enophthalmous
volume of orbit
时间窗: one to six months
using CT scan to measure orbital volume pre and postoperative
次要结局
未报告次要终点
研究者
mona samy sheta
lecturer of oral and maxillofacial surgery department
Tanta University