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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.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05439512
Enrollment
7
Registered
2022-06-30
Start date
2021-08-01
Completion date
2023-07-27
Last updated
2024-02-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Orbital Fractures

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.

Interventions

PROCEDUREtransantral orbital floor reconstruction by titanium mesh

reconstruction of orbital floor fracture by patient specific titanium mesh

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
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.

Design outcomes

Primary

MeasureTime frameDescription
enophthamus6 monthswill calculate the amount of alteration and quantity of Enophthalmos by mean of a Post-Op Soft window CT scan in mm

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026