Comparison of Two Different Modalities for Orbital Reconstruction Based on CAD-CAM Technology: A Clinical Randomized Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- measurement of Changes in orbital bony volume
研究概览
简要总结
Reconstruction of orbital defects resulting after trauma; tumor resection; maxillary cyst; craniofacial anomalies and sequestrated bone.... etc., has been a challenging issue over the years and this owing to the complicated anatomy of orbit. Inaccurate orbital reconstruction may lead to devastating cosmetic and functional complications. Titanium mesh for orbital reconstruction has now become "probably" the most popular material for orbital wall reconstruction worldwide. Innovation of CAD-CAM technology and its application in maxillofacial surgery will markedly improve the surgical outcome. This study will assess the accuracy of orbital reconstruction using CAD-CAM technology and to compare two different modalities for orbital reconstruction based on this technology.
详细描述
This study will be a prospective cohort study. It will include patients treated with the custom-made implants for orbital blow out fractures, ZMC fractures or tumors. The sample will consist of 34 patients who will need orbital reconstruction and will be operated in Maxillofacial, Head and Neck Unit, General Surgery Department, Faculty Of Medicine, Sohag University, Egypt. The patients will be randomly divided into two groups, group (A) reconstructed with patient specific implant and group (B) reconstructed with preformed plate preoperatively bended on stereolithographic model. The reconstructive outcomes are assessed by clinical and ophthalmological examinations and accuracy analysis by comparing the preoperative and postoperative multi slice computed tomography data. All patients will be assessed clinically, ophthalmologically, and radiographically using computed tomography (CT) then virtual surgical planning and custom-made patient implant will be manufactured. Post-operative clinical evaluation will be done, and radiographic evaluation of all patients will be done by CT scan within one week and 6 months after the procedure. comparing data of the two groups will be done using appropriate methods.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •fracture of the orbital floor and/or medial wall and/or lateral wall.
- •complex fracture of the zygomatic bone (those affecting orbital volume).
- •Old orbital fractures on either side causing enophthalmos, diplopia, cosmetic asymmetry.
- •Periorbital neoplasm affecting orbital volume and need surgical resection
排除标准
- •injury to the globe that restricts surgical reconstruction.
- •neurological diseases with influence on eye motility or sight.
- •Patients with special needs.
- •Medically compromised patients who are not fit for surgery.
- •Patients refused participation in this study.
研究组 & 干预措施
Group A (patient specific titanium implant)
(reconstruction with patient specific titanium implant)
干预措施: orbital bone reconstruction with patient specific titanium implant (Procedure)
Group B (preformed plate bended on stereolithographic model)
(reconstruction with preformed titanium plate preoperatively bended on stereolithographic model)
干预措施: orbital bone reconstruction with preformed titanium plate preoperatively bended on stereolithographic model (Procedure)
结局指标
主要结局
measurement of Changes in orbital bony volume
时间窗: preoperative and one week and 6 months post-operative
pre and post operative reconstructed orbit volume will be measured using multi slice computed tomography (MSCT) image loaded on software and compared with preoperative and with healthy non affected orbit
次要结局
- measurement of Changes in globe position in the bony orbit(preoperative and one week and 6 months post operative)
- measurement of Changes in zygomaticomaxillary complex symmetry(preoperative and one week and 6 months post operative)
研究者
Hatem Adel Aboelhassan
specialist of maxillofacial, head and neck surgery
Sohag University