Clinical trial NCT06958510: Modified Anatomical Mesh In The Management Of Orbito-Zygomatico-Maxillary Complex Fractures
Official title: Modified Anatomical Mesh In The Management Of Orbito-Zygomatico-Maxillary Complex Fractures. A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Orbital Fractures
Zygomatic Fractures
Keywords: anatomical mesh
3D-mesh
orbital mesh
orbital fracture
zygomatic fracture
reconstruction
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2025-05-06
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients with Orbito-Zygomaticomaxillary complex fractures with orbital floor defect managed with 3D-Modified Anatomic Mesh
Primary purpose: TREATMENT

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

Eligibility criteria: 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.

Primary outcomes:
measure: Radiographic assessment of the management of the Orbito-Zygomaticomaxillary Complex fracture
timeFrame: 1 week
Secondary outcomes:
measure: Periorbital ecchymosis
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Faculty of Dentistry, Alexandria University
Study officials:
References: