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Orbital Floor Fracture Repair by Titanium Mesh Via Transantral Approach.

Sponsor
Cairo University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05439512
Collaborator
(none)
10
Enrollment
1
Location
18
Anticipated Duration (Months)
0.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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:
    Observational
    Anticipated Enrollment :
    10 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Feasibility of Patient-specific Titanium Mesh Via A Transantral Approach for Repair of Orbital Floor Fractures.
    Actual Study Start Date :
    Aug 1, 2021
    Anticipated Primary Completion Date :
    Jan 1, 2023
    Anticipated Study Completion Date :
    Feb 1, 2023

    Outcome Measures

    Primary Outcome Measures

    1. enophthamus [6 months]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patients with unilateral orbital floor fractures indicated for surgical repair.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Faculty of Dentistry,Cairo University Cairo Egypt

    Sponsors and Collaborators

    • Cairo University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Aliaa Khalaf Abd Ellatief Mohamed, doctor, Cairo University
    ClinicalTrials.gov Identifier:
    NCT05439512
    Other Study ID Numbers:
    • 3310
    First Posted:
    Jun 30, 2022
    Last Update Posted:
    Jun 30, 2022
    Last Verified:
    Jun 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Orbital Fractures
    Fractures, Bone

    Study Results

    No Results Posted as of Jun 30, 2022