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

NCT ID: NCT06958510

Last Updated: 2025-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-01

Study Completion Date

2025-06-15

Brief Summary

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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

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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

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Orbital Fractures Zygomatic Fractures

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Patients with Orbito-Zygomaticomaxillary complex fractures with orbital floor defect managed with 3D-Modified Anatomic Mesh
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
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

Study Groups

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

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

Group Type ACTIVE_COMPARATOR

3D-Modified Anatomical-Mesh.

Intervention Type DEVICE

3D-Modified Anatomical-Mesh.

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

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

Group Type EXPERIMENTAL

conventional orbital rim miniplates and orbital mesh configuration

Intervention Type DEVICE

conventional orbital rim miniplates and orbital mesh configuration

Interventions

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3D-Modified Anatomical-Mesh.

3D-Modified Anatomical-Mesh.

Intervention Type DEVICE

conventional orbital rim miniplates and orbital mesh configuration

conventional orbital rim miniplates and orbital mesh configuration

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Patients suffering from Orbito-Zygomaticomaxillary complex fractures with fracture in the orbital floor and orbital floor defect(16).
2. Fractures that are indicated for open reduction and internal fixation.
3. Patients suffering from ocular complications:

1. Monocular diplopia.
2. Enophthalmos above 2 mm.
3. Restricted ocular motility.
4. Patients with orbital wall defects with orbital soft tissue herniation into the maxillary sinus.
5. Adult patient either male or female that agrees to present for follow-up visits for an adequate postoperative period.

Exclusion Criteria

1. Patients with isolated orbital floor defects and blowout fractures.
2. Patients with isolated zygomatico-maxillary complex fracture with no orbital floor/ walls defects.
3. Patients with bilateral orbital defects.
4. Patients with Infected wounds in periorbital region.
5. Medically compromised patients rendering them inoperable.
6. Patients with ruptured globe or blindness.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alexandria University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Faculty of Dentistry, Alexandria University

Alexandria, Alexandria Governorate, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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3D-MAM

Identifier Type: -

Identifier Source: org_study_id