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NCT05439512 Clinical Trial

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
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design

Related Conditions & MeSH terms

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
See also
  Status Clinical Trial Phase
Completed NCT03057405 - Intra-operative (IO) Navigation and IO-CBCT for 3D Orbital Reconstruction
Terminated NCT03673865 - The Use of 3D Printing in Orbital Fractures N/A
Completed NCT00584506 - Computer Aided Evaluation of Orbital Volume N/A
Recruiting NCT03887988 - Orbital Fractures Registry
Not yet recruiting NCT04271137 - Correction of Enophthalmos and Orbital Volume Using Pre-bent Mesh Versus 3d Printed Onlay in Orbital Fracture Cases N/A
Completed NCT02736461 - Factors Associated With Postoperative Strabismus After Floor Fracture Repair N/A
Completed NCT00233922 - Reconstruction of the Orbit With a Bioresorbable Polycaprolactone Implant Phase 2
Withdrawn NCT01504568 - The Use of Prophylactic Antibiotics in Isolated Blowout Fractures N/A
Not yet recruiting NCT03813732 - Using the Transconjuctival Approach Alone Versus Using it Together With Lateral Canthotomy in Orbital Fractures N/A
Recruiting NCT01464541 - Orbital Fractures Measurement: Intraoperative Versus Computed Tomography (CT) Scan N/A
Completed NCT01432964 - Use of a Low Profile Titanium Mesh in Orbital Reconstruction N/A
Enrolling by invitation NCT06294535 - The Accuracy of Reconstruction of Orbital Walls Fracture Using Prebent Mesh Versus Patient Specific Implant N/A
Recruiting NCT04704414 - Exophthalmometry With 3D Face Scanners N/A
Recruiting NCT06369129 - Accuracy& Orbital Volume Using Patient Specific Titanium Implant Vs Zirconia for Orbital Floor Reconstruction N/A