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

NCT07280533 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-12-12

No results posted yet for this 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.

Conditions

  • Facial Bone Fracture
  • Maxillofacial Injury
  • Zygomaticomaxillary Complex Fracture

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.

Sponsors & Collaborators

  • Suez canal university hospitals

    collaborator UNKNOWN

  • Suez Canal University

    lead OTHER

Principal Investigators

  • Hossam Shaban El Fadly, principle investigator · Suez Canal University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-12-25
Primary Completion
2026-10-01
Completion
2026-11-01

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07280533 on ClinicalTrials.gov