NCT03683615Unknown不适用
Resorbable Polymer Plates in Repair of Blowout Orbital Floor Fractures
Minia University0 个研究点目标入组 20 人开始时间: 2016年7月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 20
- 主要终点
- anatomical reduction of the fracture
研究概览
简要总结
It is a prospective study to evaluate the use of resorbable plates for the repair of blow out orbital floor fractures over a follow up period of one year at both cosmetic and functional levels.
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
- 10 Years 至 50 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Class I, II blowout floor fracture.
- •Presented within 2 weeks of trauma.
- •Have muscle or soft tissue distortion with clinically significant diplopia, enophthalmos or restrictive strabismus.
排除标准
- •Comminuted orbital fractures involving the rim.
- •Associated globe injuries.
- •Delayed presentation.
研究组 & 干预措施
patients with traumatic recent orbital blow out fractures
Other
干预措施: repair of orbital floor fractures using resorbable plates (Procedure)
结局指标
主要结局
anatomical reduction of the fracture
时间窗: one month
reduction of the fractured segment and restore the normal orbital volume and contents . assessment of reduction by measuring the changes in the orbital volume using computed tomography
次要结局
- improvement of symptoms(6 to 12 months)
研究者
Tamer Ismail Gawdat
clinical professor
Cairo University
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