Pre-adaptation of In-stock Mesh Using In-house 3D Patient Specific Model to Reconstruct Unilateral Primary Orbital Fracture
| Registry | NCT07882121 |
|---|---|
| Status | Recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: triple, treatment |
| Enrollment | 30 (Estimated) |
| Sponsor | Ain Shams University (Other) |
| Conditions | Orbital Fractures, Unilateral, Recent |
| Interventions | 3D printed patient specific model, Conventional, Brainlab navigation system (Procedure, device) |
| Dates | start 2025-06-01, primary completion 2027-03-01 (estimated), completion 2027-04-15 (estimated), first posted 2026-10-20, last updated 2026-10-20 |
| Locations | 2 sites in Egypt |
Related Papers Related Patents Related Grants Related Experts
All trials for Orbital Fractures All trials for Unilateral All trials of 3D printed patient specific model All trials of Conventional
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,
1. 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.
2. 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
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Control - Conventional orbital fracture reconstruction | Active comparator | Procedure: Conventional | Patients 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 model | use 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 system | 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 |
Sex: All, ages: 18 Years to 55 Years
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
| Facility | City | Country | Status |
|---|---|---|---|
| Ain shams university hospitals, department of plastic, burn and maxillofacial surgery | Cairo, Abbasia | Egypt | Recruiting |
| Ain shams university hospitals | Cairo, Cairo Governorate | Egypt | Completed |