此页面是自动翻译的,不保证翻译的准确性。请参阅 英文版 对于源文本。

Accuracy of Positioning Guide and Customized Plate in Zygomaticomaxillary Complex Fractures

2026年5月19日 更新者:Abdellatif Saad Abdellatif Nawar、Cairo University

Accuracy of Positioning Guide and Customized Titanium Plate for Reduction and Fixation of Zygomaticomaxillary Complex Fracture: A Case Series

The goal of this clinical trial is to evaluate the accuracy and stability of positioning guides and customized titanium plates in the treatment of Zygomaticomaxillary Complex (ZMC) fractures. The main questions it aims to answer are:

  • Is the anatomical reduction achieved using a virtual planning-based positioning guide accurate when compared to preoperative plans?
  • Does the customized titanium plate provide stable fixation during the follow-up period?

Researchers will compare the actual postoperative outcome to the preoperative virtual surgical plan to see if the customized workflow improves anatomical alignment.

Participants will:

  • Undergo a preoperative Computed Tomography (CT) scan for virtual surgical planning.
  • Receive surgical treatment using a patient-specific positioning guide and customized titanium plate.
  • Complete follow-up assessments including postoperative CT scans and clinical evaluations for 6 months.

研究概览

详细说明

The clinical workflow for managing unilateral Zygomaticomaxillary Complex (ZMC) fractures begins with a standardized diagnostic phase. Patients undergo a thorough medical and dental history followed by a comprehensive clinical examination. A high-resolution preoperative Computed Tomography (CT) scan (T0) is acquired within one week prior to the intervention to visualize fracture patterns and the extent of displacement. The Digital Imaging and Communications in Medicine (DICOM) data is imported into specialized medical imaging software, such as Materialise Mimics or 3-matic, for three-dimensional (3D) reconstruction and Virtual Surgical Planning (VSP).

During the digital planning phase, the fractured zygomaticomaxillary complex is virtually reduced by mirroring the unaffected contralateral side to achieve optimal anatomical symmetry. Based on this virtual model, a patient-specific positioning guide is designed to fit the bone surface and indicate exact locations for plate and screw placement. Simultaneously, a customized titanium plate is designed to conform perfectly to the reduced bone contours, incorporating optimal screw hole positions to maximize stability and avoid vital structures. These plates are fabricated using additive manufacturing techniques, specifically selective laser melting, to ensure high precision and biocompatibility.

The surgical procedure is performed under general anesthesia. Appropriate surgical approaches, including lateral eyebrow and intraoral vestibular incisions, are used to expose the fracture site. The positioning guide is utilized to facilitate the accurate relocation of ZMC fragments according to the preoperative virtual plan. Once the fracture is accurately reduced, the custom-made titanium plate is adapted to the bone surface and secured with screws to achieve rigid internal fixation, minimizing the need for intraoperative plate bending.

Postoperative care includes an immediate follow-up Computed Tomography (CT) scan (T1) within 1 to 3 days to assess the accuracy of fracture reduction and plate placement by superimposing the postoperative actual model onto the preoperative virtual plan. Clinical follow-up occurs at regular intervals (1 week, 1 month, 3 months, 6 months, and 1 year) to assess wound healing, facial symmetry, ocular function, and mouth opening. A long-term follow-up CT scan (T2) is obtained at 6 months to evaluate bone healing and the long-term stability of the fixation.

研究类型

介入性

注册 (估计的)

8

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Cairo、埃及
        • department of oral and maxillofacial surgery, faculty of dentistry, Cairo university

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  • Patients diagnosed with Zygomatico-maxillary complex fractures requiring surgical intervention.
  • Patients aged 18 years or older.
  • Patients willing to provide informed consent and comply with follow-up protocols.
  • Patients with adequate bone quality and quantity for stable fixation.

Exclusion Criteria:

  • Patients with comminuted ZMC fractures that preclude the use of custom-made guides based on mirroring the contra lateral side.
  • Patients with pre-existing facial deformities or asymmetries that would interfere with accurate assessment of fracture reduction.
  • Patients with systemic diseases or conditions that contraindicate elective surgery or impair bone healing (e.g., uncontrolled diabetes, severe osteoporosis, active malignancy, and immunosuppression).
  • Patients on medications affecting bone metabolism (e.g., long-term corticosteroids, bisphosphonates). Patients with active infections in the maxillofacial region.
  • Pregnant or lactating women.
  • Patients with psychiatric disorders or unrealistic expectations.
  • Patients who are unable to undergo CT scans or follow post-operative instructions.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:不适用
  • 介入模型:单组作业
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Virtual Planning and Customized Plates
Patients with ZMC fractures undergoing surgical treatment using 3D virtual planning and patient-specific titanium plates.
A 3D-printed positioning guide designed through virtual surgical planning to assist in the accurate reduction of ZMC fractures.
A custom-fabricated titanium plate designed to fit the patient's specific anatomy for rigid fixation of ZMC fractures.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Accuracy of Fracture Reduction
大体时间:one week postoperative
Evaluation of the accuracy of fracture reduction achieved using the positioning guide and customized titanium plate. This will be assessed by superimposing the post-operative computed tomography (CT) scans onto the pre-operative virtual surgical plan. The difference will be reported as linear deviation, measured in millimeters (mm).
one week postoperative
Assessment of Facial Symmetry (Malar Projection)
大体时间:6 months postoperatively
Evaluation of aesthetic outcome and facial symmetry by assessing the malar projection. This will be measured clinically or via imaging (e.g., comparing the fractured side to the intact side). The outcome will be reported as the linear discrepancy or difference between the two sides, measured in millimeters (mm).
6 months postoperatively

次要结果测量

结果测量
措施说明
大体时间
Assessment of Ocular Motility and Diplopia
大体时间:6 months postoperatively
Clinical assessment of functional recovery regarding ocular motility. Patients will be clinically examined for the presence or absence of diplopia (double vision) in different fields of gaze. The outcome will be reported as a categorical variable (e.g., Presence / Absence of diplopia).
6 months postoperatively
Total Operative Time
大体时间:Day of surgery (Intraoperative)
The total duration of the surgical procedure measured in minutes, from the initial incision to the final closure.
Day of surgery (Intraoperative)
Patient Satisfaction
大体时间:6 months postoperatively
Evaluation of the patient's overall satisfaction with the functional and aesthetic outcomes of the procedure. This will be assessed using a Visual Analog Scale (VAS) ranging from 0 to 10, where 0 indicates "completely dissatisfied" and 10 indicates "completely satisfied". The reported value will be the numerical score on this scale.
6 months postoperatively

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 研究主任:Prof. Ramy Ragab Elbialy, prof. of maxillofacial surgery、Department of Oral and maxillofacial surgery,Faculty of dentistry, Cairo university
  • 研究主任:Dr. Mohamed Ali Zain Elabden, lecturer of maxillofacial surg、department of oral and maxillofacial surgery, faculty of dentistry, Cairo university

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2025年11月1日

初级完成 (估计的)

2026年12月1日

研究完成 (估计的)

2027年9月1日

研究注册日期

首次提交

2026年4月29日

首先提交符合 QC 标准的

2026年5月19日

首次发布 (实际的)

2026年5月27日

研究记录更新

最后更新发布 (实际的)

2026年5月27日

上次提交的符合 QC 标准的更新

2026年5月19日

最后验证

2026年5月1日

更多信息

与本研究相关的术语

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

订阅