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Comparing Pre-adaptation of In-stock Mesh Over In-house 3D Patient Specific Model to Reconstruct Unilateral Primary Orbital Fracture With and Without Intraoperative Navigation vs Conventional Intraoperative Free-hand Mesh Bending
Sponsor: Ain Shams University
Summary
The investigators study the accuracy of repairing unilateral primary orbital fractures using a new technique, using 3D printed patient specific model to preoperative adapting of the readily available in sock titanium mesh, the model is generated using patient's own CT (DICOM files), to be compared with a control group where conventional intraoperative free-hand adaptation of the same mesh is done, comparing results with a third group using intraoperative navigation system as quality control for better positioning of the preadapted mesh , Assessment is done both radiologically and clinically, 1. CLINICALLY : 4 visits * Baseline (PREOP). * POSTOP over 1,3 and 6 months interval, subjects assessed for binocular diplopia and limitation of ocular motility using follow my finger test in 8 cardinal gazes, enophthalmos using objective Hertle's exophthalmometer, hypoesthesia over infraorbital nerve distribution. 2. Radiologically CT maxillofacial to calculate the difference of orbital volume between fractured and normal orbit, pre and postoperatively using Brainlab software workflow. Preoperatively : defect size is calculated and Postoperatively: proper position of the implant by superimposition (fusion) of postop CT over preop plan
Official title: Pre-adaptation of In-stock Mesh Using In-house 3D Patient Specific Model to Reconstruct Unilateral Primary Orbital Fracture
Key Details
Gender
All
Age Range
18 Years - 55 Years
Study Type
INTERVENTIONAL
Enrollment
30
Start Date
2025-06-01
Completion Date
2027-04-15
Last Updated
2026-10-20
Healthy Volunteers
No
Conditions
Interventions
3D printed patient specific model
An in-house three-dimensional patient-specific model is produced from preoperative computed tomography imaging to assist surgical planning for unilateral orbital fracture reconstruction. The model depicts the orbital defect and the surrounding available bony ledges, allowing direct visualization of the defect boundaries and identification of the bony support that the mesh must reach and rest upon. This distinguishes the model from models that reproduce only the intended reconstructed orbital contour. Before surgery, an available stock mesh is shaped using the model to achieve the planned orbital contour and adequate coverage of the defect, extending to the identified bony ledges. During surgery, the pre-adapted mesh is placed to reconstruct the orbital defect, with adjustments as required to achieve an appropriate fit and support.
Conventional
intraoperative visualization of orbital defect, freehand shaping and bending of available mesh
Brainlab navigation system
intraoperative quality control check using navigation as an additive step to identify surrounding boney ledges for better accuracy of the pre-adapted mesh position
Locations (2)
Ain shams university hospitals, department of plastic, burn and maxillofacial surgery
Cairo, Abbasia, Egypt
Ain shams university hospitals
Cairo, Cairo Governorate, Egypt