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

NCT06958510 | Completed

• 1 other identifier: 3D-MAM
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Orbital Fractures; Zygomatic Fractures

Keywords

anatomical mesh; 3D-mesh; orbital mesh; orbital fracture; zygomatic fracture; reconstruction

Outcome Measures

Primary Outcomes (1)

• Radiographic assessment of the management of the Orbito-Zygomaticomaxillary Complex fracture

  Radiographic assessment of the management of the Orbito-Zygomaticomaxillary Complex fracture

  1 week

Secondary Outcomes (1)

• Periorbital ecchymosis

  6 weeks

Study Arms (2)

Patients with Orbito-Zygomaticomaxillary Complex fracture managed with 3D-Modified Anatomical-Mesh

ACTIVE COMPARATOR

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

EXPERIMENTAL

Patients with Orbito-Zygomaticomaxillary Complex fracture managed with conventional orbital rim mini

Device: conventional orbital rim miniplates and orbital mesh configuration

Interventions

3D-Modified Anatomical-Mesh. DEVICE

3D-Modified Anatomical-Mesh.

Patients with Orbito-Zygomaticomaxillary Complex fracture managed with 3D-Modified Anatomical-Mesh

conventional orbital rim miniplates and orbital mesh configuration DEVICE

conventional orbital rim miniplates and orbital mesh configuration

Patients with Orbito-Zygomaticomaxillary Complex fracture managed with conventional orbital rim mini

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients suffering from Orbito-Zygomaticomaxillary complex fractures with fracture in the orbital floor and orbital floor defect(16).
• Fractures that are indicated for open reduction and internal fixation.
• Patients suffering from ocular complications:
• Monocular diplopia.
• Enophthalmos above 2 mm.
• Restricted ocular motility.
• Patients with orbital wall defects with orbital soft tissue herniation into the maxillary sinus.
• Adult patient either male or female that agrees to present for follow-up visits for an adequate postoperative period.

You may not qualify if:

• Patients with isolated orbital floor defects and blowout fractures.
• Patients with isolated zygomatico-maxillary complex fracture with no orbital floor/ walls defects.
• Patients with bilateral orbital defects.
• Patients with Infected wounds in periorbital region.
• Medically compromised patients rendering them inoperable.
• Patients with ruptured globe or blindness.

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Faculty of Dentistry, Alexandria University

Alexandria, Alexandria Governorate, 21523, Egypt

Location

MeSH Terms

Conditions

Orbital Fractures; Zygomatic Fractures

Condition Hierarchy (Ancestors)

Maxillofacial Injuries; Facial Injuries; Craniocerebral Trauma; Trauma, Nervous System; Nervous System Diseases; Skull Fractures; Fractures, Bone; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Sequentially numbered, opaque, sealed envelopes (SNOSE) allocation concealment method will be utilized. Each participant included in the study will be given a serial number that will be used in the allocation. These numbers will be written in identical sheets of paper with the group to which each participant is allocated and placed inside opaque envelopes carrying the respective names of participants. A trial independent personnel will be assigned the role of keeping the envelopes and unfolding them only at the time of the operation, so that the participant is allocated to a group which is concealed from the operator
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients with Orbito-Zygomaticomaxillary complex fractures with orbital floor defect managed with 3D-Modified Anatomic Mesh

Study Record Dates

• First Submitted: April 16, 2025
• First Posted: May 6, 2025
• Study Start: October 1, 2024
• Primary Completion: March 1, 2025
• Study Completion: June 15, 2025
• Last Updated: December 31, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP
• Access Criteria: to any one who required them after deidentification

Locations

EG (1)