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NOT YET RECRUITING
NCT07280533
NA

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

Sponsor: Suez Canal University

View on ClinicalTrials.gov

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.

Official title: Accuracy of Virtual Surgical Planning in Reduction of Zygomatico-Maxillary Fractures A Randomized Clinical Controlled Study

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2025-12-25

Completion Date

2026-11-01

Last Updated

2025-12-12

Healthy Volunteers

Yes

Interventions

PROCEDURE

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.

DEVICE

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.

PROCEDURE

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.

DEVICE

Titanium miniplates and screws (Anton Hipp)

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

Locations (1)

Suez Canal University

Cairo, Egypt