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

ConditionsFacial Bone FractureMaxillofacial InjuryZygomaticomaxillary Complex Fracture
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSuez Canal University

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Virtual surgical planning and 3D model printing

    Procedure/Surgery

    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

    Device

    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)

    Procedure/Surgery

    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)

    Device

    Surgeon-contoured titanium miniplates applied intraoperatively at the necessary fixation points.

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: Virtual Surgical Planning (VSP) - Prebent MiniplatesExperimental treatment 2 interventions
Group B: Traditional Open Reduction and FixationActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Accuracy of Fracture Reduction

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.

Time frame
3 months postoperatively

Secondary outcomes

1

Facial symmetry

Measurement of midline deviation and the distance (mm) from facial midline to the most lateral point of the malar eminence on both sides using standardized frontal photographs. Symmetry is expressed as the absolute difference in millimeters.

Time frame
1 week, 1 month, and 3 months postoperatively
2

Eye Movement (Diplopia in Gaze Positions)

Number of the 9 standard gaze positions in which the participant reports diplopia during clinical examination. The examiner will assess ocular motility in primary position, up gaze, down gaze, right gaze, left gaze, and the 4 oblique gaze positions. Diplopia will be recorded as present or absent in each position, producing a total score from 0 to 9.

Time frame
1 week and 3 months postoperatively
3

Postoperative Complications

Number of participants developing postoperative complications including infection, wound dehiscence, trismus, or sensory deficit. Each complication will be recorded as "yes/no" for each patient.

Time frame
Up to 3 months postoperatively
4

Surgical Time

Total duration of surgery recorded in minutes from initial incision to final wound closure using the operating room timing system.

Time frame
Intraoperative (single measurement)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Suez Canal University

Lead sponsor

Suez canal university hospitals

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: