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

Not Applicable

Active, not recruiting

• Conditions: Orbital Fractures; Zygomatic Fractures

• Registration Number: NCT06958510
• Lead Sponsor: Alexandria University

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.

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

Study Timeline

• Study Start: 2024-10-01
• Primary Completion: 2025-03-01
• Status Verified: 2025-04
• Study First Submitted: 2025-04-16
• Study First Submitted QC: 2025-04-27
• Last Update Submitted: 2025-04-27
• Study First Posted: 2025-05-06
• Last Update Posted: 2025-05-06
• Study Completion: 2025-06-15

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 24

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Radiographic assessment of the management of the Orbito-Zygomaticomaxillary Complex fracture	1 week	Radiographic assessment of the management of the Orbito-Zygomaticomaxillary Complex fracture

Secondary Outcome Measures

Name	Time	Method
Periorbital ecchymosis	6 weeks	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.

Trial Locations

Locations (1)

Faculty of Dentistry, Alexandria University; 🇪🇬 Alexandria, Egypt