跳至主要内容
临床试验/NCT06369129
NCT06369129招募中不适用

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

Cairo University2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2024年4月6日最近更新:
适应症

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:

  1. Case history including personal data, medical, surgical history and family history.
  2. A full examination of the cranial and maxillofacial skeleton and soft tissue .
  3. Evaluation of Visual Functions
  4. Ophthalmologic consultation and clearance
  5. Radiographic examination: CT scan
  6. All DICOM data will be imported to the surgical planning software.

Virtual planning:

  1. A midsagittal plane will be constructed then the normal orbit will be mirrored to the affected side.
  2. 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.
  3. 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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ola Alaa El-Din Abd El-Monem Mohamed

Assistant lecturer

Cairo University

研究点 (2)

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