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临床试验/NCT04214405
NCT04214405已完成不适用

One Point Versus Two Point Fixation of Tripodal Zygomatic Fractures

Mohamed Gamal Thabet2 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2020年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
68
试验地点
2
主要终点
union of fractures

研究概览

简要总结

The zygomatic bone defines the anterior and lateral projection of the face and articulates with the frontal, sphenoid,temporal, and maxillary bones. The zygomatic complex is responsible for the protection of the orbital contents and the mid-facial contour. Fracture of the zygomatic complex is one of the most common facial injuries in maxillofacial trauma and predominately appears in young adult males. The etiology of zygomatic complex fractures primarily includes road traffic accidents, violent assaults, falls and sports injuries. The main clinical features of zygomatic complex fractures include diplopia, enophthalmos, subconjunctival ecchymosis, extraocular muscle entrapment, cosmetic deformity with depression of the malar eminence, malocclusion and neurosensory disturbances of the infraorbital nerve. Diagnosis of zygomatic complex fractures is usually clinical with confirmation by computed tomography (CT) scan. Zygomatic complex fractures with no or minimal displacement are often treated without surgical intervention, whereas fractures with functional or esthetic impairments often necessitate surgical intervention. Various surgical approaches and treatment strategies have been proposed to obtain successful treatment outcome, including the Gilles temporal approach, eyebrow, upper eyelid, transconjunctival, infraciliary lower eyelid, and intraoral vestibular approaches. The surgical approach for adequate reduction of zygomatic complex fractures must ensure a good functional and cosmetic result. Surgical reduction of zygomatic fractures by an intraoral surgical approach was first described in1909 by Keen, and several studies have subsequently documented the treatment outcome after open reduction of zygomatic complex fractures by an intraoral surgical approach.

详细描述

This study is a prospective clinical intervention study where the admitted patients do lab investigation as CBC, coagulation profile ,Kidney function test and Imaging as CT maxillofacial with axial and coronal cuts. Patients will be assigned randomly into either one of the two groups under the study using concealed envelope. Under general anaesthesia with oral or naso-tracheal intubation, open reduction and internal fixation of tripod zygomatic fractures will be done using miniplates and screws at one point (zygomaticomaxillary area) or at two points (zygomaticomaxillary and frontozygomatic areas).

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • (a) Adult patients with maxillofacial fractures including tripodal zygomatic fractures as determined on clinical and radiological finding (b) Isolated tripodal fracture zygoma

排除标准

  • patients with Le Fort I/II/III fractures

结局指标

主要结局

union of fractures

时间窗: 2 months

assessment of proper union of fractures

次要结局

未报告次要终点

研究者

发起方
Mohamed Gamal Thabet
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Mohamed Gamal Thabet

principal investigator

Assiut University

研究点 (2)

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