Accuracy of Virtual Surgical Planning Versus Traditional Technique in Zygomaticomaxillary Fracture Reduction

Condition(s) studied

Investigational drug(s) / intervention(s)

Virtual surgical planning and 3D model printing: Preoperative CT segmentation, virtual reduction of fracture fragments using 3D planning software, and printing of the reduced 3D anatomical model for plate prebending.

Prebent titanium miniplates: Titanium miniplates prebent on the printed model and used for rigid internal fixation at standard zygomatic fixation points (frontozygomatic suture, infraorbital rim, zygomaticomaxillary buttress) as indicated.

Conventional open reduction and internal fixation (ORIF): Standard surgical exposure and manual reduction of fracture fragments with intraoperative confirmation of alignment, followed by contouring and application of titanium miniplates and screws for fixation.

Titanium miniplates and screws (Anton Hipp): Surgeon-contoured titanium miniplates applied intraoperatively at the necessary fixation points.

Study summary

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.

Eligibility

Primary outcome measure(s)

• Accuracy of Fracture Reduction — 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.

Trial sites (1)

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