Reconstruction of Orbital Floor Blow-out Fractures by Titanium Mesh Versus Autogenous Iliac Graft

NCT07340879 | Completed

• 1 other identifier: 04-2023-300338
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Blow-out fractures result from direct blunt impacts to the orbit which causes an immediate rise increase in intra-orbital pressure. Decompression via fracture of the orbital floor then occurs. Motor vehicle accidents are the main cause of orbital trauma. Also, industrial accidents, sports-related facial trauma, and assaults are important causes. Clinical manifestations include ecchymosis, limitation of eye movements resulting in diplopia, enophthalmos. Very rarely, severe pain and nausea immediately after the injury are reported. Radiologic evaluation including computed tomography (CT), plane radiology and magnetic resonance imaging (MRI) are the mainstay diagnostic modalities used for evaluation of cases with orbital trauma. Treatment of the orbital blow-out fractures is aimed at restoring floor continuity, thus providing adequate support for orbital contents preventing their herniation and incarceration, thereby possible subsequent fibrosis of soft tissues most importantly extraocular muscles. Various alloplastic or autogenous grafts are used for reconstruction of orbital blow-out fractures.

Conditions

Blow-Out Fractures

Keywords

Orbital fractures; titanium mesh; blow-out

Outcome Measures

Primary Outcomes (1)

• Assess visual acuity, extra-ocular motility, pupillary reaction. Also, the degree of enophthalmos

  CDVA expressed as decimal notation using a chart projector utilizing built in Snellen's charts. Also, ocular motility examination in the six cardinal positions of eye movements was carried out to document any limitation of eye movement (direction and degree). Moreover, Hertel's exophthalmometer was used to measure the degree of enophthalmos.

  1 year

Study Arms (2)

Patients with orbital blow-out fractures

ACTIVE COMPARATOR

Treated by immediate surgical reconstruction of orbital floor blow-out fractures by titanium mesh (within 2 week of the trauma)

Procedure: Titanium mesh

Patients with orbital blow-out fractures were selected irrespective of their age and gender

ACTIVE COMPARATOR

Treated by immediate reconstruction of orbital floor by autogenous iliac graft (within 2 week of the trauma)

Procedure: autogenous iliac graft

Interventions

Titanium mesh PROCEDURE

Insertion of prefabricated titanium mesh to close the defect in the orbital floor

Patients with orbital blow-out fractures

autogenous iliac graft PROCEDURE

Incision over the iliac bone to take iliac bone graft which cover the defect in the orbital floor that is measured intraoperatively.

Patients with orbital blow-out fractures were selected irrespective of their age and gender

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Clinical Enophthalmos, diplopia, and/or limited ocular motility in one or more directions.
• Radiological:
• \- CT scan (axial, coronal \& 3 dimensional): Fracture of the orbital floor with herniation of the orbital contents (extra-ocular muscles, or orbital fat)

You may not qualify if:

• patients with bilateral orbital fractures or severe facial fractures.
• Patients with bad general condition or uncontrolled diabetes mellitus.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Faculty of medicine, Assiut

Asyut, Egypt

Location

Related Publications (3)

• Kim YS, Kim JH, Hwang K. The Frequency of Decreased Visual Acuity in Orbital Fractures. J Craniofac Surg. 2015 Jul;26(5):1581-3. doi: 10.1097/SCS.0000000000001860.

  PMID: 26114513 BACKGROUND

• Jordan DR, Allen LH, White J, Harvey J, Pashby R, Esmaeli B. Intervention within days for some orbital floor fractures: the white-eyed blowout. Ophthalmic Plast Reconstr Surg. 1998 Nov;14(6):379-90. doi: 10.1097/00002341-199811000-00001.

  PMID: 9842557 BACKGROUND

• Bord SP, Linden J. Trauma to the globe and orbit. Emerg Med Clin North Am. 2008 Feb;26(1):97-123, vi-vii. doi: 10.1016/j.emc.2007.11.006.

  PMID: 18249259 BACKGROUND

MeSH Terms

Conditions

Orbital Fractures

Condition Hierarchy (Ancestors)

Maxillofacial Injuries; Facial Injuries; Craniocerebral Trauma; Trauma, Nervous System; Nervous System Diseases; Skull Fractures; Fractures, Bone; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of ophthalmology

Study Record Dates

• First Submitted: January 6, 2026
• First Posted: January 14, 2026
• Study Start: May 2, 2020
• Primary Completion: May 30, 2023
• Study Completion: May 20, 2024
• Last Updated: January 21, 2026

Record last verified: 2026-01

Locations

EG (1)