Evaluation of the Accuracy of Zygomatico-Maxillary Complex Fracture Reduction And Fixation Using A Full Digital Workflow Versus Conventional Protocol: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Zygomatic reposition
研究概览
简要总结
this study aims To evaluate The Accuracy of Zygomatico- Maxillary Complex (ZMC) Fracture reduction and fixation Using customized Patient-Specific implant and patient-specific predictive holes surgical guide Versus Conventional Technique of reduction and fixation.
详细描述
The ZMC has multiple points of articulation with the craniofacial skeleton making accurate assessment of reduction at all articulations intraoperative in multiple planes very challenging and the interference of soft tissue edema and a narrowed visual field increases the possibility of intraoperative overcorrection or underestimation of pre-injured position of all fracture lines at the same time resulting in a suboptimal reduction. As a trial to maximize the benefits of digital planning carrying the plan into a real operating room using a patient-specific surgical guide to predrill screw holes and guide patient-specific implants during fixation according to the planning depend on CT scan.
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
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Zygomatic Fracture Types III, IV, V, VII, and VIII according to Rowe and Killey's classification.
- •Age range (18-60 years).
- •Patients are willing for the surgical procedure and follow-up, with informed consent
排除标准
- •Zygomatic Fracture Type I, II according to Rowe and Killey's classification.
- •Patients with contraindications for general anesthesia.
- •Patient on radiotherapy.
- •Patients suffer from bone disease.
研究组 & 干预措施
study group
all cases that will be allocated in this group will undergo treatment using a full digital protocol depending on planning software and the planning will be carried out into the operating room using 3D printed predictive holes surgical guides to determine accurately the optimum position of customized plates
干预措施: Reduction and fixation of zygomatico- Maxillary complex fracture using a full digital work flow (Procedure)
control group
patients in this group will be treated using a conventional protocol of reduction depending on visualization intraoperative and tactile sensation and will be fixed using a stock miniplates and screws.
干预措施: Reduction and fixation of zygomatico- maxillary complex fracture using a conventional free hand protocol (Procedure)
结局指标
主要结局
Zygomatic reposition
时间窗: immediate postoperative
the accuracy of zygomatic bone reduction and fixation using postoperative CT scan
次要结局
- intraoperative time(during the operation)
- paresthesia(pre operative, immediate postoperative and 6 months post operative)
- patient satisfaction(6 months postoperative)
研究者
Dina Ayman Fayek
Assistant lecturer in Oral and Maxillofacial department in Future university in Egypt
Cairo University