Assessment of Accuracy and Orbital Volume Using Patient Specific Titanium Implant Vs Patient Specific Zirconia Implant for Orbital Floor Reconstruction in Blowout Fractures A Randomized Clinical Trial: Comparative Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Orbital Volume
研究概览
简要总结
Comparative study used to assess if the patient specific zirconia implant will provide better accuracy, intraoperative adaptability, precise orbital volume and soft tissue reaction with more cost effectiveness than the patient specific titanium implants in orbital floor reconstruction after blow out fractures .
详细描述
Patients of both groups will be subjected to:
- Case history including personal data, medical, surgical history and family history.
- A full examination of the cranial and maxillofacial skeleton and soft tissue .
- Evaluation of Visual Functions
- Ophthalmologic consultation and clearance
- Radiographic examination: CT scan
- All DICOM data will be imported to the surgical planning software.
Virtual planning:
- A midsagittal plane will be constructed then the normal orbit will be mirrored to the affected side.
- The mirrored orbital floor will be meshed with 1.6 mm holes then its peripheries will be extended downwards by 3 mm and meshed also in order to accommodate the fixation.
- The designed part will be subtracted then exported in Stereolithography (STL) format to be fabricated .
The surgery will be done under General anesthesia and undertaken within 14 days to prevent fibrosis. Can be delayed 24-72 hours to allow the edema to subside before undertaking surgery.
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
- 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
- 是
入选标准
- •Patients with blow out fracture isolated and / or combined with other fracture.
- •Age group: from 18 to 60 years old
- •No sex predilection
- •Patients with no contraindications to surgical intervention.
- •Patients willing for the surgical procedure and follow-up, with an informed consent.
- •Exclusion Criteria :
- •Medically compromised patients.
- •Patients with history of previous orbital reconstruction surgery.
- •Uncooperative patients.
- •Patients with systemic contraindication to general anesthesia.
排除标准
- 未提供
结局指标
主要结局
Orbital Volume
时间窗: immediately post operative
will be measured with CT scan in mm3
次要结局
- Cost effectiveness(through study completion, an average of 1 year)
- Patient satisfaction(through study completion, an average of 1 year)
- Accuracy of the patient specific implant in the orbital floor reconstruction(immediately post operative)
研究者
Ola Alaa El-Din Abd El-Monem Mohamed
Assistant lecturer
Cairo University
