Orbital Floor Fracture Repair by Titanium Mesh Via Transantral Approach.

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.

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Key information

Conditions

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

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry,Cairo University

Cairo, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

transantral orbital floor reconstruction by titanium mesh

Procedure

reconstruction of orbital floor fracture by patient specific titanium mesh

Other names: trans antral orbital floor reconstruction

Primary outcomes

enophthamus

Time frame: 6 months

will calculate the amount of alteration and quantity of Enophthalmos by mean of a Post-Op Soft window CT scan in mm

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start: 2021
Primary completion: 2023
Study completion: 2023
First posted: Jun 30, 2022
Registry last updated: Feb 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed