Orbital Floor Fracture Repair by Titanium Mesh Via Transantral Approach.

Orbital Fractures Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05439512
• Other study ID #: 3310
• Status: Completed
• Phase: N/A
• Start date: August 1, 2021
• Est. completion date: July 27, 2023

Study information

• Verified date: February 2024
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: July 27, 2023
• Est. primary completion date: June 5, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Fractures, Bone
• Orbital Fractures

Intervention

Procedure:
• transantral orbital floor reconstruction by titanium mesh
reconstruction of orbital floor fracture by patient specific titanium mesh

Locations

Country	Name	City	State
Egypt	Faculty of Dentistry,Cairo University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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