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Clinical Trials/NCT05439512
NCT05439512
Completed
Not Applicable

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

Cairo University1 site in 1 country7 target enrollmentAugust 1, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Orbital Fractures
Sponsor
Cairo University
Enrollment
7
Locations
1
Primary Endpoint
enophthamus
Status
Completed
Last Updated
2 years ago

Overview

Brief 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.

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.

Registry
clinicaltrials.gov
Start Date
August 1, 2021
End Date
July 27, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Aliaa Khalaf Abd Ellatief Mohamed

principal investigator

Cairo University

Eligibility Criteria

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.

Outcomes

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

Study Sites (1)

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