Blow-Out FracturesNCT07340879
Reconstruction of Orbital Floor Blow-out Fractures by Titanium Mesh Versus Autogenous Iliac Graft
A study testing Titanium mesh and autogenous iliac graft in people with Blow-Out Fractures, run by Assiut University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Blow-Out Fractures
- What is being tested?
- Titanium mesh and autogenous iliac graft
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 2 May 2020to 20 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- patients with bilateral orbital fractures or severe facial fractures.
- Patients with bad general condition or uncontrolled diabetes mellitus.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Blow-Out Fractures
- Being tested
- Titanium mesh, autogenous iliac graft
- Keywords
- Orbital fractures, titanium mesh, blow-out
- Medical subject headings
- Orbital Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Titanium meshProcedure or surgery
Insertion of prefabricated titanium mesh to close the defect in the orbital floor
autogenous iliac graftProcedure or surgery
Incision over the iliac bone to take iliac bone graft which cover the defect in the orbital floor that is measured intraoperatively.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: Procedure: autogenous iliac graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2026
- Study start2 May 2020
- Primary completion30 May 2023
- Study completion20 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Blow-Out FracturesStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Menatallah Gamal Saleh, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07340879
- Sponsor's protocol ID
- 04-2023-300338
- Status last verified
- Jan 2026
- First submitted
- 6 Jan 2026
- Last updated
- 21 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 26114513Jordan 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.
PubMed 9842557Bord 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.
PubMed 18249259
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reconstruction of Orbital Floor Blow-out Fractures by Titanium Mesh Versus Autogenous Iliac Graft
- ClinicalTrials.gov ID
- NCT07340879
- Acronym / sponsor ID
- 04-2023-300338
- Conditions
- Blow-Out Fractures
- Keywords
- Orbital fractures, titanium mesh, blow-out
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 2 May 2020 (actual)
- Primary completion
- 30 May 2023 (actual)
- Study completion
- 20 May 2024 (actual)
- First posted
- 14 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with orbital blow-out fractures | Active comparator | Procedure: Titanium meshTreated by immediate surgical reconstruction of orbital floor blow-out fractures by titanium mesh (within 2 week of the trauma) |
| Patients with orbital blow-out fractures were selected irrespective of their age and gender | Active comparator | Procedure: autogenous iliac graftTreated by immediate reconstruction of orbital floor by autogenous iliac graft (within 2 week of the trauma) |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Clinical Enophthalmos, diplopia, and/or limited ocular motility in one or more directions.
- CT scan (axial, coronal \& 3 dimensional): Fracture of the orbital floor with herniation of the orbital contents (extra-ocular muscles, or orbital fat)
Key exclusion criteria (2 listed)
- patients with bilateral orbital fractures or severe facial fractures.
- Patients with bad general condition or uncontrolled diabetes mellitus.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Titanium meshInsertion of prefabricated titanium mesh to close the defect in the orbital floor | Procedure or surgery | Patients with orbital blow-out fractures |
| autogenous iliac graftIncision over the iliac bone to take iliac bone graft which cover the defect in the orbital floor that is measured intraoperatively. | Procedure or surgery | Patients with orbital blow-out fractures were selected irrespective of their age and gender |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- Background: PubMed 26114513Kim 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.
- Background: PubMed 9842557Jordan 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.
- Background: PubMed 18249259Bord 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.
- Individual participant dataSharing planned: Undecided
Related trials for Blow-Out Fractures
Active, not recruitingObservational study
Orbital Fractures Registry
Orbital Fractures, Blow Out Fracture of Orbit
Active, not recruiting
Endoscopically Assisted Management of Maxillofacial Fractures: A Prospective Study on Efficacy and Outcomes
Maxillofacial Injuries, Maxillofacial Trauma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Titanium mesh and autogenous iliac graft in people with Blow-Out Fractures, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess visual acuity, extra-ocular motility, pupillary reaction. Also, the degree of enophthalmos (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07340879, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2026.