Interlocking Polyetheretherketone Patient-Specific Implants for Orbital Floor Reconstruction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Hypoglobus
研究概览
简要总结
Patients with large orbital floor fracture were reconstructed with interlocking polyetheretherketone patient-specific implant and will be evaluated clinically and radiographically
详细描述
Twenty two patients with large orbital floor fracture will be included in this study. Patients will be received, examined and managed at the Oral & Maxillofacial Surgery Department, Faculty of Dentistry, Tanta University. Full clinical examination and radiographic examination using multi axial C.T Scan for proper diagnosis and treatment planning. DICOM files will be imported into surgical planning software and used for fabrication of interlocking polyetheretherketone patient specific implant which will be ready for sterilization and insertion. After written informed consent from the patient, the surgery will be done under G.A, either infraorbital or transconjunctival incision will be done according to the case. Follow up: All patients will be examined clinically for hypoglobus, enophthalmos, ocular motility and diplopia during 2nd week, 1st month and 6 months & radiographically for orbital volume immediately and 6 months postoperatively
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with large orbital blow out fracture either isolated or combined with other fracture
- •Patients willing for surgical operation and follow up
- •Patients with no contraindications for surgical intervention
排除标准
- •Patients who are not fit for G.A
- •Uncooperative patients
研究组 & 干预措施
Interlocking polyetheretherketone patient specific implant for orbital floor reconstruction
This study is conducted on twenty two patients with unilateral large orbital floor fracture reconstructed with interlocking polyetheretherketone patient specific implant
干预措施: large orbital floor fracture (Procedure)
结局指标
主要结局
Hypoglobus
时间窗: 2 weeks
It is the downward displacement of the eyeball of affected eye. It is measured by drawing imaginary line horizontally across the patient's inter-pupillary axis and determine if the pupil of the affected eye is lower or not
Enophthalmos
时间窗: 2 weeks
It is defined as the posterior displacement of the eyeball within the orbit. It was measured by the aid of exophthalmometer. Assessment is consisting of four grades as follow: grade 0:no enophthalmos grade 1:mild enophthalmos(less than 1 mm) grade 2:moderate enophthalmos(from 1 to 2 mm) grade 3:severe enophthalmos(over 2 mm)
Orbital volume
时间窗: 2 weeks
C.T. images of the patient are imported in DICOM format into the automatic orbital analysis software and the orbital volume of both orbital cavities are measured
Ocular motility
时间窗: 2 weeks
It is done by asking the patient to follow a moving target into the diagnostic positions of gaze, observing the extent of movement of each eye. The amount of limitation of movement is classified as: grade 1:slight limitation grade 2:moderate limitation grade 3:marked limitation grade 4:no movement
Diplopia
时间窗: 2 weeks
It is defined as perception of two images of the same object in visual space. It is assessed if it is present in primary position of gaze or in secondary position of gaze
次要结局
- Ocular motility(6 months)
- Hypoglobus(6 months)
- Orbital volume(6 months)
- Diplopia(6 months)
- Enophthalmos(6 months)
研究者
Maram Nashaat Breshah
Lecturer of Oral & Maxillofacial Surgery
Tanta University