Orbital FracturesNCT07882121
Comparing Pre-adaptation of In-stock Mesh Over In-house 3D Patient Specific Model to Reconstruct Unilateral Primary Orbital Fracture With and Without Intraoperative Navigation vs Conventional Intraoperative Free-hand Mesh Bending
A study testing 3D printed patient specific model, Conventional and Brainlab navigation system in people with Orbital Fractures and Unilateral, run by Ain Shams University at 2 sites in Egypt.
Trial summary
The investigators study the accuracy of repairing unilateral primary orbital fractures using a new technique, using 3D printed patient specific model to preoperative adapting of the readily available in sock titanium mesh, the model is generated using patient's own CT (DICOM files), to be compared with a control group… Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Orbital Fractures, Unilateral, Recent
- What is being tested?
- 3D printed patient specific model, Conventional and Brainlab navigation system
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesEgypt
- Study dates
- 1 Jun 2025to 15 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Fracture orbital wall:
- Timing: Recent (<3 weeks from trauma) Age: 18-55 years Sex: Both
- Clinical Findings:
- ± Globe malposition, Enophthalmos ≥ 2 mm or Diplopia CT Findings
- Fracture Pattern: unilateral fractures medial wall or floor of the orbit.
- Defect Size critical sized defects proved by CT
- Herniation of soft tissue, and/or muscle entrapment.
- associated non-comminuted zygomatic fracture.
Who cannot join
- Timing Delayed (> 3 weeks from trauma)
- Pattern : Bilateral orbital fractures
- Associated with Comminuted zygomatic fracture or pan-facial fracture Ocular Manifestations
- Patients with ruptured globe or associated soft tissue injury Associated conditions
- Other life-threatening condition
- Presence of systemic diseases affecting the globe position (e.g Hyperthyroidism, Horner's syndrome)
- Presence of craniofacial anomalies and Facial asymmetries.
- History of other old facial fractures Patients refusing surgery or implant.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt2 sites, 1 recruiting
- Recruiting
Ain shams university hospitals, department of plastic, burn and maxillofacial surgery
Cairo, Abbasia, 11851
Reem M. S. H. Mahmoud, MSc, +201064483493, resident153@med.asu.edu.eg
Reem M, S, H Mahmoud, MSc
- Completed
Ain shams university hospitals
Cairo, Cairo Governorate, 1815
About this study
Official title: Pre-adaptation of In-stock Mesh Using In-house 3D Patient Specific Model to Reconstruct Unilateral Primary Orbital Fracture
The investigators study the accuracy of repairing unilateral primary orbital fractures using a new technique, using 3D printed patient specific model to preoperative adapting of the readily available in sock titanium mesh, the model is generated using patient's own CT (DICOM files), to be compared with a control group where conventional intraoperative free-hand adaptation of the same mesh is done, comparing results with a third group using intraoperative navigation system as quality control for better positioning of the preadapted mesh , Assessment is done both radiologically and clinically,
- CLINICALLY : 4 visits
Read more
- Baseline (PREOP).
- POSTOP over 1,3 and 6 months interval, subjects assessed for binocular diplopia and limitation of ocular motility using follow my finger test in 8 cardinal gazes, enophthalmos using objective Hertle's exophthalmometer, hypoesthesia over infraorbital nerve distribution.
- Radiologically CT maxillofacial to calculate the difference of orbital volume between fractured and normal orbit, pre and postoperatively using Brainlab software workflow.
Preoperatively : defect size is calculated and Postoperatively: proper position of the implant by superimposition (fusion) of postop CT over preop plan
- Conditions
- Orbital Fractures, Unilateral, Recent
- Being tested
- 3D printed patient specific model, Conventional, Brainlab navigation system
- Keywords
- Virtual surgical planning, 3D printing, CAD, Patient specific model, Pre-bent mesh, titanium mesh, orbital reconstruction, intraoperative navigation
- Medical subject headings
- Orbital Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D printed patient specific modelProcedure or surgery
An in-house three-dimensional patient-specific model is produced from preoperative computed tomography imaging to assist surgical planning for unilateral orbital fracture reconstruction. The model depicts the orbital defect and the surrounding available bony ledges, allowing direct visualization of the defect boundaries and identification of the bony support that the mesh must reach and rest upon. This distinguishes the model from models that reproduce only the intended reconstructed orbital contour.
Before surgery, an available stock mesh is shaped using the model to achieve the planned orbital contour and adequate coverage of the defect, extending to the identified bony ledges. During surgery, the pre-adapted mesh is placed to reconstruct the orbital defect, with adjustments as required to achieve an appropriate fit and support.
ConventionalProcedure or surgery
intraoperative visualization of orbital defect, freehand shaping and bending of available mesh
Brainlab navigation systemDevice
Also called Intraoperative navigator
intraoperative quality control check using navigation as an additive step to identify surrounding boney ledges for better accuracy of the pre-adapted mesh position
| Study group | Role | What they receive |
|---|---|---|
| Control - Conventional orbital fracture reconstruction | Active comparator | Patients with orbital fractures receiving the regular surgery with no new concept Receives: Procedure: Conventional |
| Intervention Group- Preadapted mesh over 3D Patient Specific model for orbital reconstruction | Experimental | use of in house 3D Patient Specific model to preadapt the same mesh to increase percision and decrease operative time Receives: Procedure: 3D printed patient specific model |
| Intraoperative navigation positioning of Preadapted mesh for orbital reconstruction | Experimental | same technique for second group , added to it the use of navigation intraoperatively to detect the surrounding boney ledges to identify if it has role in better mesh positioning Receives: Procedure: 3D printed patient specific model; Device: Brainlab navigation system |
What is being measured
The primary outcome is the main question the study is designed to answer.
accuracy of restoration of orbital volume
preoperative and postoperative assessment in the difference between the volume of the fractured orbit and the unaffected contralateral orbit, measured using computed tomography. Orbital volume discrepancy is expressed in cubic centimetres. A reduction in the magnitude of the discrepancy indicates closer restoration to the orbit.
Measured: immediate postoperatively
Secondary outcomes (3)
Operative time
Duration of mesh insertion in minutes, using the same defined start and end points in both groups.
Measured: intraoperative
Sequence of clinical outcome (Enophthalmos, Diplopia, Limited ocular motility)
Difference in globe projection between the affected and unaffected eyes, measured in millimetres using the hertles exophthalmometer. Diplopia and ocular motility by examination
Measured: preoperatively and 1,3,6 months postoperatively
Mesh position
Assessed radiologically by fusing postoperative CT over preoperative plan, and clinically by assessment of any palpable mesh or screws
Measured: radiologically: immediate, Clinically: 1,3 and 6 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2026
- Study start1 Jun 2025
- Primary completion1 Mar 2027 (estimated)
- Study completion15 Apr 2027 (estimated)
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 Orbital FracturesStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Reem Mohamed Saad Hamed Mahmoud , MBBCh, MSc, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07882121
- Sponsor's protocol ID
- FMASU MD116/2025
- Status last verified
- Oct 2026
- First submitted
- 10 Oct 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Verbist M, Dubron K, Bila M, Jacobs R, Shaheen E, Willaert R. Accuracy of surgical navigation for patient-specific reconstructions of orbital fractures: A systematic review and meta-analysis. J Stomatol Oral Maxillofac Surg. 2024 Jun;125(3):101683. doi: 10.1016/j.jormas.2023.101683. Epub 2023 Nov 10.
PubMed 37951500Raisian S, Fallahi HR, Khiabani KS, Heidarizadeh M, Azdoo S. Customized Titanium Mesh Based on the 3D Printed Model vs. Manual Intraoperative Bending of Titanium Mesh for Reconstructing of Orbital Bone Fracture: A Randomized Clinical Trial. Rev Recent Clin Trials. 2017;12(3):154-158. doi: 10.2174/1574887112666170821165206.
PubMed 28828975Singh AK, Khanal N, Chaulagain R, Sharma N, Thieringer FM. Is the Pre-Shaping of an Orbital Implant on a Patient-Specific 3D-Printed Model Advantageous Compared to Conventional Free-Hand Shaping? A Systematic Review and Meta-Analysis. J Clin Med. 2023 May 12;12(10):3426. doi: 10.3390/jcm12103426.
PubMed 37240532
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre-adaptation of In-stock Mesh Using In-house 3D Patient Specific Model to Reconstruct Unilateral Primary Orbital Fracture
- ClinicalTrials.gov ID
- NCT07882121
- Acronym / sponsor ID
- FMASU MD116/2025
- Conditions
- Orbital Fractures, Unilateral, Recent
- Keywords
- Virtual surgical planning, 3D printing, CAD, Patient specific model, Pre-bent mesh, titanium mesh, orbital reconstruction, intraoperative navigation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 15 Apr 2027 (estimated)
- First posted
- 20 Oct 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.
The investigators study the accuracy of repairing unilateral primary orbital fractures using a new technique, using 3D printed patient specific model to preoperative adapting of the readily available in sock titanium mesh, the model is generated using patient's own CT (DICOM files), to be compared with a control group where conventional intraoperative free-hand adaptation of the same mesh is done, comparing results with a third group using intraoperative navigation system as quality control for better positioning of the preadapted mesh , Assessment is done both radiologically and clinically,
- CLINICALLY : 4 visits
- Baseline (PREOP).
- POSTOP over 1,3 and 6 months interval, subjects assessed for binocular diplopia and limitation of ocular motility using follow my finger test in 8 cardinal gazes, enophthalmos using objective Hertle's exophthalmometer, hypoesthesia over infraorbital nerve distribution.
- Radiologically CT maxillofacial to calculate the difference of orbital volume between fractured and normal orbit, pre and postoperatively using Brainlab software workflow.
Preoperatively : defect size is calculated and Postoperatively: proper position of the implant by superimposition (fusion) of postop CT over preop plan
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control - Conventional orbital fracture reconstruction | Active comparator | Procedure: ConventionalPatients with orbital fractures receiving the regular surgery with no new concept |
| Intervention Group- Preadapted mesh over 3D Patient Specific model for orbital reconstruction | Experimental | Procedure: 3D printed patient specific modeluse of in house 3D Patient Specific model to preadapt the same mesh to increase percision and decrease operative time |
| Intraoperative navigation positioning of Preadapted mesh for orbital reconstruction | Experimental | Procedure: 3D printed patient specific model, Device: Brainlab navigation systemsame technique for second group , added to it the use of navigation intraoperatively to detect the surrounding boney ledges to identify if it has role in better mesh positioning |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Fracture orbital wall:
- Timing: Recent (<3 weeks from trauma) Age: 18-55 years Sex: Both
- ± Globe malposition, Enophthalmos ≥ 2 mm or Diplopia CT Findings
- Fracture Pattern: unilateral fractures medial wall or floor of the orbit.
- Defect Size critical sized defects proved by CT
Key exclusion criteria (8 listed)
- Timing Delayed (> 3 weeks from trauma)
- Pattern : Bilateral orbital fractures
- Associated with Comminuted zygomatic fracture or pan-facial fracture Ocular Manifestations
- Patients with ruptured globe or associated soft tissue injury Associated conditions
- Other life-threatening condition
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 |
|---|---|---|
| 3D printed patient specific modelAn in-house three-dimensional patient-specific model is produced from preoperative computed tomography imaging to assist surgical planning for unilateral orbital fracture reconstruction. The model depicts the orbital defect and the surrounding available bony ledges, allowing direct visualization of the defect boundaries and identification of the bony support that the mesh must reach and rest upon. This distinguishes the model from models that reproduce only the intended reconstructed orbital contour. Before surgery, an available stock mesh is shaped using the model to achieve the planned orbital contour and adequate coverage of the defect, extending to the identified bony ledges. During surgery, the pre-adapted mesh is placed to reconstruct the orbital defect, with adjustments as required to achieve an appropriate fit and support. | Procedure or surgery | Intervention Group- Preadapted mesh over 3D Patient Specific model for orbital reconstruction, Intraoperative navigation positioning of Preadapted mesh for orbital reconstruction |
| Conventionalintraoperative visualization of orbital defect, freehand shaping and bending of available mesh | Procedure or surgery | Control - Conventional orbital fracture reconstruction |
| Brainlab navigation systemAlso: Intraoperative navigatorintraoperative quality control check using navigation as an additive step to identify surrounding boney ledges for better accuracy of the pre-adapted mesh position | Device | Intraoperative navigation positioning of Preadapted mesh for orbital reconstruction |
Primary outcome
accuracy of restoration of orbital volume
Time frame: immediate postoperatively
preoperative and postoperative assessment in the difference between the volume of the fractured orbit and the unaffected contralateral orbit, measured using computed tomography. Orbital volume discrepancy is expressed in cubic centimetres. A reduction in the magnitude of the discrepancy indicates closer restoration to the orbit.
3 secondary outcomes
Operative time
Time frame: intraoperative
Sequence of clinical outcome (Enophthalmos, Diplopia, Limited ocular motility)
Time frame: preoperatively and 1,3,6 months postoperatively
Mesh position
Time frame: radiologically: immediate, Clinically: 1,3 and 6 months postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Background: PubMed 37951500Verbist M, Dubron K, Bila M, Jacobs R, Shaheen E, Willaert R. Accuracy of surgical navigation for patient-specific reconstructions of orbital fractures: A systematic review and meta-analysis. J Stomatol Oral Maxillofac Surg. 2024 Jun;125(3):101683. doi: 10.1016/j.jormas.2023.101683. Epub 2023 Nov 10.
- Background: PubMed 28828975Raisian S, Fallahi HR, Khiabani KS, Heidarizadeh M, Azdoo S. Customized Titanium Mesh Based on the 3D Printed Model vs. Manual Intraoperative Bending of Titanium Mesh for Reconstructing of Orbital Bone Fracture: A Randomized Clinical Trial. Rev Recent Clin Trials. 2017;12(3):154-158. doi: 10.2174/1574887112666170821165206.
- Background: PubMed 37240532Singh AK, Khanal N, Chaulagain R, Sharma N, Thieringer FM. Is the Pre-Shaping of an Orbital Implant on a Patient-Specific 3D-Printed Model Advantageous Compared to Conventional Free-Hand Shaping? A Systematic Review and Meta-Analysis. J Clin Med. 2023 May 12;12(10):3426. doi: 10.3390/jcm12103426.
- Individual participant dataSharing planned: Undecided
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3D printed patient specific model, Conventional and Brainlab navigation system in people with Orbital Fractures and Unilateral, run by Ain Shams University at 2 sites 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 8 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Reem Mohamed Mahmoud, MBBCh, MSc (+201064483493, +201223418832, reem.saas@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
accuracy of restoration of orbital volume (time frame: immediate postoperatively). 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 NCT07882121, 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 20 Oct 2026.