Evaluation of Patient-specific PEEK Implants for Post-maxillectomy Orbital Floor Reconstruction
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Enophthalmos analysis
研究概览
简要总结
The study aims to evaluate the utilization of Patient-specific PEEK implantsd in reconstruction of orbital floor after maxilla ablation surgery
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
- •1. Unilateral invasive benign or malignant tumors of the maxilla that requires orbital floor resection.
- •3. Brown class III maxillectomy defects patients
- •Patients with immediate orbital floor reconstruction will be enrolled in this study.
排除标准
- •Medically compromised patients contradicting operation.
- •Delayed orbital floor reconstruction cases will be excluded.
- •Bilateral cases will be excluded.
研究组 & 干预措施
patients will be treated by Brown class III maxillectomy and immediate orbital floor reconstruction
干预措施: Patient-specific PEEK implants (Device)
结局指标
主要结局
Enophthalmos analysis
时间窗: Immediately after the surgery
On the axial cuts, at the level of a horizontal dissecting line (Baseline) was drawn joining the anterior tips of the lateral orbital margin bilaterally. The perpendicular distance from the top of the corneal bulge to this line was measured for both the affected and the contralateral globes. The difference in the measurement value between the normal and the affected orbit was used to conclude the presence or absence of enophthalmos, or proptosis of the orbit, using the equation (Globe Δ = Contralateral value-Ipsilateral Value). A reported difference between both globes of more than 2 mm is designated as enophthalmos
Orbital Volume Evaluation
时间窗: Immediately after the surgery
An appraisal of the orbital volume will be performed as an objective evaluation modality for the assessment of the accuracy of orbital floor reconstruction after Brown class III maxillectomies in both groups. A virtual orbital model of the reconstructed eye will be created using manual segmentation module in the 3D segmentation and image analysis software\* for the following: * Ipsilateral preoperative virtually reconstructed orbit. * Ipsilateral immediate postoperative CT-scan of the reconstructed orbit. * Contralateral preoperative and immediate postoperative orbit. The volume of the created orbital model will be automatically calculated and the mean value for each model will be calculated. In each group, efficiency of orbital floor reconstruction will be evaluated by comparing the postoperative value with the preoperative one and with the normal contralateral side.
次要结局
- Ocular postoperative complications(1 week postopreatively)
- Ocular motility and Diplopia(1 week postopreatively)