An interventional study of 3D-Modified Anatomical-Mesh. and conventional orbital rim miniplates and orbital mesh configuration in Orbital Fractures and Zygomatic Fractures, sponsored by Alexandria University. Completed at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-31.
Sponsored by Alexandria University · Not applicable, Interventional, and Treatment
Among 12 studies in Orbital Fractures with a site in Egypt — 3 open to participants now, 3 under way, none of them phase 3. Orbital Fractures · Egypt.
Among the 12 studies in Orbital Fractures with a site in Egypt, this one is the 6th largest by enrollment, is one of 2 that started in 2024, is one of 11 with no phase, and was the 8th registered.
29 studies on the registry are indexed under Orbital Fractures; 6 are open to participants now.
Browse Orbital Fractures studies →3 of the 12 studies in Orbital Fractures with a site in Egypt are open now. Recruiting first, the newest first:
Alexandria University · Sites in Egypt
Ages 20–50 · Healthy volunteers
Ain Shams University · Sites in Egypt
Ages 18–55
Cairo University · Sites in Egypt
Ages 18–60 · Healthy volunteers
A study can be open while its sites in Egypt have not opened yet or have stopped. Only those recruiting at a site in Egypt →
Of the 3 Orbital Fractures studies recruiting now, none set no upper age limit and 3 stop at 75 or younger; none take children under 18; 2 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
12 studies; the count open now beside each. This study's row is marked.
First in 2018; this study’s year is marked. 2 started in 2024.
This study's enrollment of 24 is below the median of 28 across 20 interventional studies indexed under Orbital Fractures.
Median enrollment 22 across the 12 interventional studies. Of the 5 that completed or were terminated, 0 (0%) have results posted.
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None of the 12 has an industry lead sponsor. The 7 most frequent:
Alexandria University is the lead sponsor of 606 studies on the registry; 141 are open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Alexandria University has 2 studies filed under Orbital Fractures — fewer than ten, so there is no comparison to draw.
2 of the studies in Orbital Fractures with a site in Egypt that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07759440Alexandria UniversityClinical Outcomes of Transconjunctival Vs Transcutaneous Approaches in Orbital Fracture Repair | 2026-11-25 |
| NCT07882121Ain Shams UniversityComparing 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 | 2027-03-01 |
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Among the 12 studies in Orbital Fractures with a site in Egypt, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patients suffering from ocular complications:
Exclusion Criteria:
Patients with Orbito-Zygomaticomaxillary Complex fracture managed with 3D-Modified Anatomical-Mesh
Device: 3D-Modified Anatomical-Mesh.
Patients with Orbito-Zygomaticomaxillary Complex fracture managed with conventional orbital rim mini
Device: conventional orbital rim miniplates and orbital mesh configuration
3D-Modified Anatomical-Mesh.
conventional orbital rim miniplates and orbital mesh configuration
Radiographic assessment of the management of the Orbito-Zygomaticomaxillary Complex fracture
Radiographic assessment of the management of the Orbito-Zygomaticomaxillary Complex fracture
Time frame: 1 week
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.
Time frame: 6 weeks
Plan to share: 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
Supporting information: Statistical analysis plan
Access criteria: to any one who required them after deidentification
No publications or documents are linked to this record.
Ran from Oct 2024 to primary completion in Mar 2025, 5 months.
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This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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