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

Alexandria University

Status: Active, not recruiting

Conditions: Zygomatic Fractures; Orbital Fractures

Treatments: Device: 3D-Modified Anatomical-Mesh.; Device: conventional orbital rim miniplates and orbital mesh configuration

Study type: Interventional

Funder types: Other

Identifiers

NCT06958510

3D-MAM

Details and patient eligibility

About

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.

Full 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

Enrollment: 24 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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24 participants in 2 patient groups

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

Active Comparator group

Description:

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

Treatment:

Device: 3D-Modified Anatomical-Mesh.

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

Experimental group

Description:

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

Treatment:

Device: conventional orbital rim miniplates and orbital mesh configuration