Evaluating The Prebent Titanium Mesh for Zygomatico-Orbital Reconstruction in Twelve Patients Measuring Multiple Ophthalmologic Parameters, Aesthetic Results, Orbital Volume, Area of Bone Defect, Layout Angle, Gab Length and The Accuracy of Reconstruction

NCT07103187 | Completed DMC

• 1 other identifier: R-OS-1-19-8
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

Purpose: The aim of this study was to evaluate the role of using a prebent titanium mesh on a 3D-printed model as an intraoperative guide to reconstruct orbito-zygomatic-maxillary complex (OZMC) fractures. Subjects and method: This is a prospective, interventional, longitudinal, single armed case series study that was carried out on twelve patients with unilateral displaced orbito-zygomatico-maxillary complex (OZMC) fracture indicated for orbital floor reconstruction as evidenced by clinical and radiographic examination. Open reduction and internal fixation were utilized to treat those fractures, patients were collected from the department of Oral and Maxillofacial surgery, Faculty of Dentistry, Tanta University. Post-operative evaluation: all patients underwent regular follow up for six months. The following parameters were evaluated: visual acuity, external appearance of the eye including hypoglobus and enophthalmos, diplopia, ocular motility, the aesthetic results, orbital volume, area of bone defect, layout angle, gab length and the zygomatic reconstruction.

Conditions

Zygomaticomaxillary Complex Fracture; Orbital Floor Fractures; Ophthalmic Trauma

Keywords

Orbital reconstruction; Orbital fractures; Automatic segmentation; 3D orbital analysis; Orbital volume; Orbito-zygomatico-maxillary complex fracture

Outcome Measures

Primary Outcomes (3)

• Orbital volume

  By obtaining CT scan of the face then the DICOM data was imported by BONELOGIC CMF ORBITAL software provided by Disior company which performed automated 3D analysis for the orbits preoperatively and postoperatively.

  Preoperatively. Postoperatively within two weeks after the operation.

• Area of bone defect (Orbital symmetry)

  By obtaining CT scan of the face then the DICOM data was imported by BONELOGIC CMF ORBITAL software provided by Disior company which performed automated 3D analysis for the orbits preoperatively and postoperatively.

  Preoperatively. Postoperatively within two weeks after the operation.

• Acuraccy of Orbito-Zygomatico-maxillary complex fracture reconstruction

  On a postoperative CT scan of the face adequate zygomatic reduction was judged by evaluating any involved parts from the following reference points, including zygomaticofrontal suture, zygomatico-sphenoidal suture, zygomaticomaxillary buttress, inferior orbital rim, and zygomatic arch, which was judged by two experienced surgeons as good, satisfactory or poor.

  Only postoperatively within two weeks after the operation.

Secondary Outcomes (7)

• Visual acuity

  Preoperative. Postoperatively 2 weeks, 1 month, 2 months, 3 months and 6 months.

• Vertical dystopia

  Preoperative. Postoperatively 2 weeks, 1 month, 2 months, 3 months and 6 months.

• Enophthalmos

  Preoperative. Postoperatively 2 weeks, 1 month, 2 months, 3 months and 6 months.

• Diplopia

  Preoperative. Postoperatively 2 weeks, 1 month, 2 months, 3 months and 6 months.

• Ocular motility

  Preoperative. Postoperatively 2 weeks, 1 month, 2 months, 3 months and 6 months.

Other Outcomes (1)

• Aesthetic results

  6 months postoperatively.

Study Arms (1)

Only single arm of the study

EXPERIMENTAL

This is the only arm of the study containing 12 patients who will be operated for reconstruction for unilateral OZMC fracture. A lot of outcome measures will be measured to evaluate the effectiveness of the intervention.

Procedure: Zygomatico-Orbital reconstruction

Interventions

Zygomatico-Orbital reconstruction PROCEDURE

Zygomatico-Orbital reconstruction was done by ORIF for the zygomatic complex fractures at multiple suture lines by mini plates and screws. Orbital floor reconstruction was done mainly by using a prebent titanium mesh on a 3D printed model.

Only single arm of the study

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with unilateral displaced zygomatico-orbital fracture (with fractured orbital floor).
• Patients with no previous history of orbital reconstruction.
• Diplopia within 30° of primary gaze.
• Radiological evidence of extraocular muscle entrapment and/or positive forced duction test.
• Enophthalmos of more than 2mm.

You may not qualify if:

• Bilateral zygomatico-orbital fractures.
• Rupture of the globe.
• Hyphema.
• Retinal detachment.
• Traumatic optic nerve lesions.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Faculty of Dentistry, Tanta University

Tanta, Algharbiah, 31511, Egypt

Location

MeSH Terms

Conditions

Orbital Fractures

Condition Hierarchy (Ancestors)

Maxillofacial Injuries; Facial Injuries; Craniocerebral Trauma; Trauma, Nervous System; Nervous System Diseases; Skull Fractures; Fractures, Bone; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer of Oral & Maxillofacial Surgery

Study Record Dates

• First Submitted: July 28, 2025
• First Posted: August 5, 2025
• Study Start: June 1, 2018
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: August 5, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: The data could be available after publication within 6 months from now.
• Access Criteria: The data will be held on a private cloud and access will be provided upon request from the corresponding author.

Locations

EG (1)