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

January 18, 2026 updated by: Menatallah Gamal Saleh, Assiut University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A prospective interventional randomized controlled study, including 80 patients (who presented at trauma unit in Assiut university hospital between May 2020 to May 2023 and fulfilled the inclusion criteria) was conducted. Patients with orbital floor blow-out fractures were selected irrespective of their age and gender. The study followed the tenets of the Helsinki declaration and guidelines of the local research committee. An informed written consent was signed by all the patients who agreed to be enrolled in the study, or their relatives if consciously disturbed patients. All operations were done within 2 weeks of the trauma.

Patients were divided into 2 groups:

  • Group I (40 patients) consists of immediate surgical reconstruction of pure orbital floor blow-out fractures by titanium mesh.
  • Group II (40 patients) consists of immediate surgical reconstruction of pure orbital floor blow-out fractures by autogenous iliac graft.

Inclusion criteria:

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).Exclusion criteria:

patients with bilateral orbital fractures or severe facial fractures. Also, patients with bad general condition or uncontrolled diabetes mellitus were excluded.

Ophthalmological examination of study subjects was performed by an expert ophthalmologist (MGA). This included examination of the anterior segment and evaluation of pupillary reflexes by penlight and slit lamp to document associated eye globe injuries. Fundus examination was carried out using binocular indirect ophthalmoscope. Also, measurement of the corrected distance visual acuity (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 in the involved eye. A difference of 2 or more millimeters between both eyes was considered significant for enophthalmos in the sunken eye. Ophthalmological features of study subjects. Postoperative care

  • A head-up position was adopted by patients in the early postoperative period with application of cold compresses in order to reduce postoperative edema.
  • Analgesia and antibiotics were prescribed.

Follow up:

Follow-up examinations to assess visual acuity, extra-ocular motility, pupillary reaction. Also, the degree of enophthalmos was measured. Assessment of sensation over the check to assess the degree of neuralgia and patients were asked about improvement in double vision. Those parameters were monitored for at least 6 months after surgery and up to one year.

Follow up orbital CT scan (coronal view was done for all patients in the study.

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Asyut, Egypt
        • Faculty of medicine, Assiut

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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)

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Patients with orbital blow-out fractures
Treated by immediate surgical reconstruction of orbital floor blow-out fractures by titanium mesh (within 2 week of the trauma)
Procedure: Titanium mesh
Insertion of prefabricated titanium mesh to close the defect in the orbital floor
Active Comparator: Patients with orbital blow-out fractures were selected irrespective of their age and gender
Treated by immediate reconstruction of orbital floor by autogenous iliac graft (within 2 week of the trauma)
Procedure: autogenous iliac graft
Incision over the iliac bone to take iliac bone graft which cover the defect in the orbital floor that is measured intraoperatively.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assess visual acuity, extra-ocular motility, pupillary reaction. Also, the degree of enophthalmos
Time Frame: 1 year
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 2, 2020

Primary Completion (Actual)

May 30, 2023

Study Completion (Actual)

May 20, 2024

Study Registration Dates

First Submitted

January 6, 2026

First Submitted That Met QC Criteria

January 6, 2026

First Posted (Actual)

January 14, 2026

Study Record Updates

Last Update Posted (Actual)

January 21, 2026

Last Update Submitted That Met QC Criteria

January 18, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 04-2023-300338

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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