Orbital Floor Fracture Repair by Titanium Mesh Via Transantral Approach.

Feasibility of Patient-specific Titanium Mesh Via A Transantral Approach for Repair of Orbital Floor Fractures.

The aim of the study is to evaluate the feasibility of CAD/CAM osteosynthesis mesh through a transantral surgical approach in the Repair of orbital floor fractures by means of clinical and radiographic findings.

Study Overview

• Status: Completed
• Conditions: Orbital Fractures
• Intervention / Treatment: Procedure: transantral orbital floor reconstruction by titanium mesh

Detailed Description

A CAD/CAM osteosynthesis mesh through a transantral approach should assumingly provide accurate reconstruction of the orbital volume and anatomy while eliminating the usual morbidity of lower eyelid approaches during orbital reconstruction.

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Faculty of Dentistry,Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Study Population

Through the utilization of a trans-antral approach, orbital floor fractures can be easily managed particularly by allowing clear visualization of the posterior edge of the orbital floor. Also, the risk of eyelid deformity and orbital floor periosteum disruption is alleviated.

Transantral visualization as an adjunct to traditional periorbital approaches has shown to improve rates of diplopia and enophthalmos.7 A 2013 review showed the utility of a transantral sublabial approach for surgical repair of an isolated orbital floor defect, including cases that required alloplastic implant or bone graft placement for rigid reconstruction.

Description

Inclusion Criteria:

• Patients with recent unilateral orbital floor fracture indicated for internal reconstruction -
• (isolated or in combination with other facial fractures)
• with existing or estimated enophthalmos based on radiographs and a contra-lateral healthy non-operated orbit.

Exclusion Criteria:

• Delayed cases (more than 2 weeks)
• previously operated cases
• bilateral orbital floor fracture.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: orbital floor fracture	Procedure: transantral orbital floor reconstruction by titanium mesh; reconstruction of orbital floor fracture by patient specific titanium mesh; Other Names: trans antral orbital floor reconstruction

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
enophthamus	will calculate the amount of alteration and quantity of Enophthalmos by mean of a Post-Op Soft window CT scan in mm	6 months

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2021
• Primary Completion (Actual): June 5, 2023
• Study Completion (Actual): July 27, 2023

Study Registration Dates

• First Submitted: June 26, 2022
• First Submitted That Met QC Criteria: June 26, 2022
• First Posted (Actual): June 30, 2022

Study Record Updates

• Last Update Posted (Actual): February 7, 2024
• Last Update Submitted That Met QC Criteria: February 5, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Maxillofacial Injuries; Facial Injuries; Skull Fractures; Fractures, Bone; Orbital Fractures
• Other Study ID Numbers: 3310 (CEAS)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No