An interventional study of 3D-Modified Anatomical-Mesh. and conventional orbital rim miniplates and orbital mesh configuration in Orbital Fractures and Zygomatic Fractures, sponsored by Alexandria University. Completed at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-31.
Sponsored by Alexandria University · Not applicable, Interventional, and Treatment
Orbito-Zygomaticomaxillary-complex fractures is a form of a complex orbital floor fracture, with affection of the inferior orbital rim and the orbital walls. According to published research, between 67 - 84 % of periorbital bone fractures are orbital floor fractures.
Evaluation of 3D-Modified Anatomic Mesh in the management of OZM- complex fractures with orbital floor defect, and compare it with the conventional fixation configuration.
Patients suffering from OZM- complex fractures was treated using 3D-Modified Anatomical Mesh for orbital floor reconstruction and orbital rim fixation. Patients was randomly allocated into study and control groups, where it is managed with the conventional 2.0-miniplate and stock mesh. A standardized surgical protocol was followed in both groups. Patients was clinically evaluated for pain, wound healing, nerve sensation, ocular motility and diplopia, and tarsal plate morphology. Moreover, radiographic survey was performed post operatively to assess the proper positioning of the implant, to confirm proper fracture reduction, and radiographic enophthalmos analysis
Patients suffering from ocular complications:
Exclusion Criteria:
Patients with Orbito-Zygomaticomaxillary Complex fracture managed with 3D-Modified Anatomical-Mesh
Device: 3D-Modified Anatomical-Mesh.
Patients with Orbito-Zygomaticomaxillary Complex fracture managed with conventional orbital rim mini
Device: conventional orbital rim miniplates and orbital mesh configuration
3D-Modified Anatomical-Mesh.
conventional orbital rim miniplates and orbital mesh configuration
Radiographic assessment of the management of the Orbito-Zygomaticomaxillary Complex fracture
Radiographic assessment of the management of the Orbito-Zygomaticomaxillary Complex fracture
Time frame: 1 week
Periorbital ecchymosis
Postoperative periorbital ecchymosis will be evaluated on a 3-points scale (0-3). The scoring system divides ecchymosis into upper and lower eyelids, and furthermore into thirds for each eyelid.
Time frame: 6 weeks
Plan to share: Yes — all data will be de-identified to protect the participant data. patients signed an informed consent for the use of their medical records and data for study
Supporting information: Sap
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Alexandria University