An interventional study of 3D printed patient specific model and Conventional in Orbital Fractures, Unilateral and Recent, sponsored by Ain Shams University. Recruiting at 2 sites in Egypt. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2026-10-20.
Sponsored by Ain Shams University · Not applicable, Interventional, and Treatment
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
Preoperatively : defect size is calculated and Postoperatively: proper position of the implant by superimposition (fusion) of postop CT over preop plan
26 studies on the registry are indexed under Orbital Fractures; 6 are open to participants now.
This study's planned enrollment of 30 is above the median of 25 across 17 interventional studies indexed under Orbital Fractures.
Browse Orbital Fractures studies →Ain Shams University is the lead sponsor of 1,930 studies on the registry; 433 are open to participants now.
Of its 33 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Clinical Findings:
± Globe malposition, Enophthalmos ≥ 2 mm or Diplopia CT Findings
Defect Size critical sized defects proved by CT
Exclusion Criteria:
Patients with orbital fractures receiving the regular surgery with no new concept
Procedure: Conventional
use of in house 3D Patient Specific model to preadapt the same mesh to increase percision and decrease operative time
Procedure: 3D printed patient specific model
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
Procedure: 3D printed patient specific model · Device: Brainlab navigation system
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.
intraoperative visualization of orbital defect, freehand shaping and bending of available mesh
intraoperative quality control check using navigation as an additive step to identify surrounding boney ledges for better accuracy of the pre-adapted mesh position
Also known as: Intraoperative navigator
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.
Time frame: immediate postoperatively
Operative time
Duration of mesh insertion in minutes, using the same defined start and end points in both groups.
Time frame: 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
Time frame: 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
Time frame: radiologically: immediate, Clinically: 1,3 and 6 months postoperatively
Plan to share: Undecided
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.