NCT06958510

Modified Anatomical Mesh In The Management Of Orbito-Zygomatico-Maxillary Complex Fractures

Modified Anatomical Mesh In The Management Of Orbito-Zygomatico-Maxillary Complex Fractures. A Randomized Clinical Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Alexandria University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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

Conditions

• Orbital Fractures
• Zygomatic Fractures

Interventions

Type	Name	Description
DEVICE	3D-Modified Anatomical-Mesh.	3D-Modified Anatomical-Mesh.
DEVICE	conventional orbital rim miniplates and orbital mesh configuration	conventional orbital rim miniplates and orbital mesh configuration

Timeline

• Start date: 2024-10-01
• Primary completion: 2025-03-01
• Completion: 2025-06-15
• First posted: 2025-05-06
• Last updated: 2025-12-31

Locations

1 site across 1 country: Egypt