Accuracy of Virtual Surgical Planning in Reduction of Zygomatico-Maxillary Fractures A Randomized Clinical Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Accuracy of Fracture Reduction
研究概览
简要总结
This randomized clinical trial aims to evaluate the accuracy and outcomes of virtual surgical planning (VSP) compared to the traditional surgical technique in the reduction of zygomaticomaxillary complex (ZMC) fractures. Twenty patients with ZMC fractures will be randomly assigned into two equal groups: one treated using virtual planning and prebent titanium miniplates, and the other treated conventionally without virtual planning. Clinical evaluation will include facial symmetry, eye movement, and postoperative complications, while radiographic assessment will be performed using CT scans three months after surgery to measure bone formation and alignment accuracy. The study seeks to determine whether virtual surgical planning improves anatomical restoration, esthetics, and functional outcomes compared to traditional methods.
详细描述
Background:
The zygomaticomaxillary complex (ZMC) is one of the most frequently fractured regions of the facial skeleton due to its prominent anatomical position. Improper reduction can lead to functional impairment, facial asymmetry, and poor esthetic results. Virtual surgical planning (VSP) and 3D printing have recently been introduced to enhance surgical precision through preoperative simulation and prebending of fixation plates. However, the clinical superiority of this technique over traditional surgical methods remains under investigation.
Objective:
To compare the accuracy and clinical outcomes of virtual surgical planning and prebent titanium miniplates versus conventional open reduction and internal fixation techniques in the management of zygomaticomaxillary complex fractures.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults (≥18 years) with clinically and radiographically confirmed ZMC fracture.
- •Fit for general anesthesia and able to undergo CT imaging.
- •Willing to sign informed consent.
排除标准
- •Systemic diseases impairing bone healing (osteoporosis, cancer, long-term steroid use).
- •Noncompliance or inability to attend follow-up visits.
- •ASA class IV-VI.
- •Previous facial deformities or fractures.
结局指标
主要结局
Accuracy of Fracture Reduction
时间窗: 3 months postoperatively
Measurement of the 3D linear discrepancy (in millimeters) between the postoperative CT model and the preoperative virtual reduction model using surface-based 3D superimposition (color-map deviation analysis). The mean deviation (mm) will be automatically calculated by the 3D analysis software.
次要结局
- Facial symmetry(1 week, 1 month, and 3 months postoperatively)
- Eye Movement (Diplopia in Gaze Positions)(1 week and 3 months postoperatively)
- Postoperative Complications(Up to 3 months postoperatively)
- Surgical Time(Intraoperative (single measurement))
- Bone Healing(3 months postoperatively)
研究者
hossam shaban
Principal Investigator, Department of Oral and Maxillofacial Surgery, Suez Canal University
Suez Canal University