NCT05439512CompletedNot Applicable
Feasibility of Patient-specific Titanium Mesh Via A Transantral Approach for Repair of Orbital Floor Fractures.
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Cairo University
- Enrollment
- 7
- Locations
- 1
- Primary Endpoint
- enophthamus
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Secondary Outcomes
No secondary outcomes reported
Investigators
Aliaa Khalaf Abd Ellatief Mohamed
principal investigator
Cairo University
Study Sites (1)
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