Accuracy of Positioning Guide and Customized Plate in Zygomaticomaxillary Complex Fractures

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство Patient-specific positioning guide
  A 3D-printed positioning guide designed through virtual surgical planning to assist in the accurate reduction of ZMC fractures.
• Устройство Customized titanium plate
  A custom-fabricated titanium plate designed to fit the patient's specific anatomy for rigid fixation of ZMC fractures.

Первичные конечные точки

• Accuracy of Fracture Reduction [Срок оценки: one week postoperative]
• Assessment of Facial Symmetry (Malar Projection) [Срок оценки: 6 months postoperatively]

Вторичные конечные точки (3)

• Assessment of Ocular Motility and Diplopia [Срок оценки: 6 months postoperatively]
• Total Operative Time [Срок оценки: Day of surgery (Intraoperative)]
• Patient Satisfaction [Срок оценки: 6 months postoperatively]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Египет · 1 центр

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

Идентификаторы

NCT: NCT07608380 · OMFS3319

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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