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

StatusRecruiting
PhaseNot applicable
Started

Free. We email you which fields changed when ClinicalTrials.gov updates this record.

Track this trial
View on ClinicalTrials.gov ↗

Record History

  1. Study First Submitted
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
Trial Details
NCT Number NCT07882121
Lead Sponsor Ain Shams University
Conditions
(from sponsor)
Orbital Fractures, Unilateral, Recent
Related terms Orbital Fractures
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov