Orbital FracturesNCT06958510
Modified Anatomical Mesh In The Management Of Orbito-Zygomatico-Maxillary Complex Fractures
A study testing 3D-Modified Anatomical-Mesh. and conventional orbital rim miniplates and orbital mesh configuration in people with Orbital Fractures and Zygomatic Fractures, run by Alexandria University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Orbital Fractures, Zygomatic Fractures
- What is being tested?
- 3D-Modified Anatomical-Mesh. and conventional orbital rim miniplates and orbital mesh configuration
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2024to 15 Jun 2025
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients suffering from Orbito-Zygomaticomaxillary complex fractures with fracture in the orbital floor and orbital floor defect(16).
- Fractures that are indicated for open reduction and internal fixation.
- Patients suffering from ocular complications:
- Monocular diplopia.
- Enophthalmos above 2 mm.
- Restricted ocular motility.
- Patients with orbital wall defects with orbital soft tissue herniation into the maxillary sinus.
- Adult patient either male or female that agrees to present for follow-up visits for an adequate postoperative period.
Who cannot join
- Patients with isolated orbital floor defects and blowout fractures.
- Patients with isolated zygomatico-maxillary complex fracture with no orbital floor/ walls defects.
- Patients with bilateral orbital defects.
- Patients with Infected wounds in periorbital region.
- Medically compromised patients rendering them inoperable.
- Patients with ruptured globe or blindness.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Dentistry, Alexandria University
Alexandria, Alexandria Governorate, 21523
About this study
Official title: Modified Anatomical Mesh In The Management Of Orbito-Zygomatico-Maxillary Complex Fractures. A Randomized Clinical Trial
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.
Read the 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
- Conditions
- Orbital Fractures, Zygomatic Fractures
- Being tested
- 3D-Modified Anatomical-Mesh., conventional orbital rim miniplates and orbital mesh configuration
- Keywords
- anatomical mesh, 3D-mesh, orbital mesh, orbital fracture, zygomatic fracture, reconstruction
- Medical subject headings
- Orbital Fractures, Zygomatic Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D-Modified Anatomical-Mesh.Device
3D-Modified Anatomical-Mesh.
conventional orbital rim miniplates and orbital mesh configurationDevice
conventional orbital rim miniplates and orbital mesh configuration
| Study group | Role | What they receive |
|---|---|---|
| Patients with Orbito-Zygomaticomaxillary Complex fracture managed with 3D-Modified Anatomical-Mesh | Active comparator | Patients with Orbito-Zygomaticomaxillary Complex fracture managed with 3D-Modified Anatomical-Mesh Receives: Device: 3D-Modified Anatomical-Mesh. |
| Patients with Orbito-Zygomaticomaxillary Complex fracture managed with conventional orbital rim mini | Experimental | Patients with Orbito-Zygomaticomaxillary Complex fracture managed with conventional orbital rim mini Receives: Device: conventional orbital rim miniplates and orbital mesh configuration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographic assessment of the management of the Orbito-Zygomaticomaxillary Complex fracture
Radiographic assessment of the management of the Orbito-Zygomaticomaxillary Complex fracture
Measured: 1 week
Secondary outcomes (1)
Periorbital ecchymosis
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.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2025
- Study start1 Oct 2024
- Primary completion1 Mar 2025
- Study completion15 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orbital FracturesStudies of the same condition, open and under way.
- More trials run by Alexandria 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
- Model description
- Patients with Orbito-Zygomaticomaxillary complex fractures with orbital floor defect managed with 3D-Modified Anatomic Mesh
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06958510
- Sponsor's protocol ID
- 3D-MAM
- Status last verified
- Apr 2025
- First submitted
- 16 Apr 2025
- Last updated
- 31 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all data will be de-identified to protect the participant data. patients signed an informed consent for the use of their medical records and data for study
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modified Anatomical Mesh In The Management Of Orbito-Zygomatico-Maxillary Complex Fractures. A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06958510
- Acronym / sponsor ID
- 3D-MAM
- Conditions
- Orbital Fractures, Zygomatic Fractures
- Keywords
- anatomical mesh, 3D-mesh, orbital mesh, orbital fracture, zygomatic fracture, reconstruction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 1 Mar 2025 (actual)
- Study completion
- 15 Jun 2025 (actual)
- First posted
- 6 May 2025 (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.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Patients with Orbito-Zygomaticomaxillary complex fractures with orbital floor defect managed with 3D-Modified Anatomic Mesh
| Arm | Type | Receives |
|---|---|---|
| Patients with Orbito-Zygomaticomaxillary Complex fracture managed with 3D-Modified Anatomical-Mesh | Active comparator | Device: 3D-Modified Anatomical-Mesh.Patients with Orbito-Zygomaticomaxillary Complex fracture managed with 3D-Modified Anatomical-Mesh |
| Patients with Orbito-Zygomaticomaxillary Complex fracture managed with conventional orbital rim mini | Experimental | Device: conventional orbital rim miniplates and orbital mesh configurationPatients with Orbito-Zygomaticomaxillary Complex fracture managed with conventional orbital rim mini |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients suffering from Orbito-Zygomaticomaxillary complex fractures with fracture in the orbital floor and orbital floor defect(16).
- Fractures that are indicated for open reduction and internal fixation.
- Patients suffering from ocular complications:
- Patients with orbital wall defects with orbital soft tissue herniation into the maxillary sinus.
- Adult patient either male or female that agrees to present for follow-up visits for an adequate postoperative period.
Key exclusion criteria (6 listed)
- Patients with isolated orbital floor defects and blowout fractures.
- Patients with isolated zygomatico-maxillary complex fracture with no orbital floor/ walls defects.
- Patients with bilateral orbital defects.
- Patients with Infected wounds in periorbital region.
- Medically compromised patients rendering them inoperable.
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-Modified Anatomical-Mesh.3D-Modified Anatomical-Mesh. | Device | Patients with Orbito-Zygomaticomaxillary Complex fracture managed with 3D-Modified Anatomical-Mesh |
| conventional orbital rim miniplates and orbital mesh configurationconventional orbital rim miniplates and orbital mesh configuration | Device | Patients with Orbito-Zygomaticomaxillary Complex fracture managed with conventional orbital rim mini |
Primary outcome
Radiographic assessment of the management of the Orbito-Zygomaticomaxillary Complex fracture
Time frame: 1 week
Radiographic assessment of the management of the Orbito-Zygomaticomaxillary Complex fracture
1 secondary outcome
Periorbital ecchymosis
Time frame: 6 weeks
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 31 Dec 2025.
- Individual participant dataSharing planned: Yes. all data will be de-identified to protect the participant data. patients signed an informed consent for the use of their medical records and data for study
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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. 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 3D-Modified Anatomical-Mesh. and conventional orbital rim miniplates and orbital mesh configuration in people with Orbital Fractures and Zygomatic Fractures, run by Alexandria 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 8 inclusion and 6 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 31 Dec 2025. 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?
Radiographic assessment of the management of the Orbito-Zygomaticomaxillary Complex fracture (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Dec 2025.