Orbital Fractures, Zygomatic Fractures
Conditions
Keywords
anatomical mesh, 3D-mesh, orbital mesh, orbital fracture, zygomatic fracture, reconstruction
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
Interventions
DEVICE3D-Modified Anatomical-Mesh.
3D-Modified Anatomical-Mesh.
DEVICEconventional orbital rim miniplates and orbital mesh configuration
conventional orbital rim miniplates and orbital mesh configuration
Sponsors
Alexandria University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
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
Intervention model description
Patients with Orbito-Zygomaticomaxillary complex fractures with orbital floor defect managed with 3D-Modified Anatomic Mesh
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Egypt
Outcome results
None listed