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

NCT07882121 — Not applicable, Recruiting, 30 participants, Ain Shams University

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Pre-adaptation of In-stock Mesh Using In-house 3D Patient Specific Model to Reconstruct Unilateral Primary Orbital Fracture

RegistryNCT07882121
StatusRecruiting
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: triple, treatment
Enrollment30 (Estimated)
SponsorAin Shams University (Other)
ConditionsOrbital Fractures, Unilateral, Recent
Interventions3D printed patient specific model, Conventional, Brainlab navigation system (Procedure, device)
Datesstart 2025-06-01, primary completion 2027-03-01 (estimated), completion 2027-04-15 (estimated), first posted 2026-10-20, last updated 2026-10-20
Locations2 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

-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 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

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+Arms and interventions

ArmTypeInterventionsDescription
Control - Conventional orbital fracture reconstructionActive comparatorProcedure: ConventionalPatients with orbital fractures receiving the regular surgery with no new concept
Intervention Group- Preadapted mesh over 3D Patient Specific model for orbital reconstructionExperimentalProcedure: 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 reconstructionExperimentalProcedure: 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
  • 3D printed patient specific model (Procedure): 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.
  • Conventional (Procedure): intraoperative visualization of orbital defect, freehand shaping and bending of available mesh
  • Brainlab navigation system (Device), also known as 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

+Outcome measures

Primary outcomes

  • accuracy of restoration of orbital volume [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.

Secondary outcomes

  • Operative time [intraoperative]: Duration of mesh insertion in minutes, using the same defined start and end points in both groups.
  • Sequence of clinical outcome (Enophthalmos, Diplopia, Limited ocular motility) [preoperatively and 1,3,6 months postoperatively]: Difference in globe projection between the affected and unaffected eyes, measured in millimetres using the hertles exophthalmometer. Diplopia and ocular motility by examination
  • Mesh position [radiologically: immediate, Clinically: 1,3 and 6 months postoperatively]: Assessed radiologically by fusing postoperative CT over preoperative plan, and clinically by assessment of any palpable mesh or screws

+Eligibility

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.

+Locations (2)

FacilityCityCountryStatus
Ain shams university hospitals, department of plastic, burn and maxillofacial surgeryCairo, AbbasiaEgyptRecruiting
Ain shams university hospitalsCairo, Cairo GovernorateEgyptCompleted

+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. PMID 37951500
  • Raisian 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. PMID 28828975
  • Singh 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. PMID 37240532