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

NCT07280533 | Not Yet Recruiting

• 1 other identifier: 1002/2025
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Zygomaticomaxillary complex fracture; ZMC fracture; Virtual surgical planning; 3D printing; Prebent titanium miniplates; Facial symmetry; Computer-assisted surgery; CT evaluation; Traditional surgical method

Outcome Measures

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.

  3 months postoperatively

Secondary Outcomes (5)

• Facial symmetry

  1 week, 1 month, and 3 months postoperatively

• Eye Movement (Diplopia in Gaze Positions)

  1 week and 3 months postoperatively

• Postoperative Complications

  Up to 3 months postoperatively

• Surgical Time

  Intraoperative (single measurement)

• Bone Healing

  3 months postoperatively

Study Arms (2)

Virtual Surgical Planning (VSP) - Prebent Miniplates

EXPERIMENTAL

Patients allocated to this arm will undergo preoperative CT segmentation and 3D reconstruction, virtual reduction of the zygomaticomaxillary complex, and 3D printing of the reduced model. Titanium miniplates will be prebent on the 3D printed model before surgery. Surgical fixation will then be performed under general anesthesia using the prebent titanium miniplates.

Procedure: Virtual surgical planning and 3D model printing; Device: Prebent titanium miniplates

Traditional Open Reduction and Fixation

ACTIVE COMPARATOR

Patients allocated to this arm will undergo conventional open reduction and internal fixation of the ZMC fracture under general anesthesia without prior virtual surgical planning or 3D-printed models. Titanium miniplates will be contoured intraoperatively by the surgical team and used for fixation at the appropriate sites.

Procedure: Conventional open reduction and internal fixation (ORIF); Device: Titanium miniplates and screws (Anton Hipp)

Interventions

Virtual surgical planning and 3D model printing PROCEDURE

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

Virtual Surgical Planning (VSP) - Prebent Miniplates

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.

Virtual Surgical Planning (VSP) - Prebent Miniplates

Conventional open reduction and internal fixation (ORIF) PROCEDURE

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.

Traditional Open Reduction and Fixation

Titanium miniplates and screws (Anton Hipp) DEVICE

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

Traditional Open Reduction and Fixation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Suez Canal University: lead
• Suez canal university hospitals: collaborator

Study Sites (1)

Suez Canal University

Cairo, Egypt

Location

Related Publications (4)

• Longeac M, Depeyre A, Pereira B, Barthelemy I, Pham Dang N. Virtual surgical planning and three-dimensional printing for the treatment of comminuted zygomaticomaxillary complex fracture. J Stomatol Oral Maxillofac Surg. 2021 Sep;122(4):386-390. doi: 10.1016/j.jormas.2020.05.009. Epub 2020 May 18.

  PMID: 32439600 RESULT

• Abdul Lateef Hassan T, Abbood Mohammed D. Virtual Surgical Planning and 3-Dimensional Printing for the Treatment of Zygomaticomaxillary Complex and/or Orbital Fracture. J Craniofac Surg. 2023 May 1;34(3):e218-e222. doi: 10.1097/SCS.0000000000009056. Epub 2022 Oct 11.

  PMID: 36217233 RESULT

• Committeri U, Magliulo R, Carraturo E, Arena A, Abbate V, Salzano G, Troise S, Barone S, Germano C, Vaira LA, Giovacchini F, Cataldo R, Grassia MG, Califano L, Piombino P. Virtual surgical planning in tripod zygomatico-maxillary complex fractures: A prospective comparison between two different strategies. J Craniomaxillofac Surg. 2024 Dec;52(12):1497-1504. doi: 10.1016/j.jcms.2024.08.020. Epub 2024 Sep 29.

  PMID: 39349348 RESULT

• Dubron K, Van Camp P, Jacobs R, Politis C, Shaheen E. Accuracy of virtual planning and intraoperative navigation in zygomaticomaxillary complex fractures: A systematic review. J Stomatol Oral Maxillofac Surg. 2022 Nov;123(6):e841-e848. doi: 10.1016/j.jormas.2022.07.003. Epub 2022 Jul 7.

  PMID: 35809796 RESULT

MeSH Terms

Conditions

Maxillofacial Injuries

Interventions

Fracture Fixation, Internal

Condition Hierarchy (Ancestors)

Facial Injuries; Craniocerebral Trauma; Trauma, Nervous System; Nervous System Diseases; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Fracture Fixation; Orthopedic Procedures; Therapeutics; Surgical Procedures, Operative

Study Officials

• Hossam Shaban El Fadly, principle investigator

  Suez Canal University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Department of Oral and Maxillofacial Surgery, Suez Canal University

Model Details: clinical trial compares two different surgical approaches for treating zygomaticomaxillary complex (ZMC) fractures): Experimental Arm (Group I): Virtual surgical planning (VSP) with 3D model printing and prebent titanium miniplates. Active Comparator Arm (Group II): Traditional open reduction and fixation without virtual planning or prebent plates.

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: December 12, 2025
• Study Start: December 25, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: December 12, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)