🌐 EnglishEN

AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

← Trials
🧪

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

RecruitingNAAges 18 Years - 55 YearsAllAin Shams University
NCT07882121 on ClinicalTrials.gov ↗
💬

In plain words

What the trial is, and whether it could suit you

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 infraorbi

Sign in to get the eligibility rules as simple questions to take to your doctor.

Sign in
📋 Eligibility rules (as published)
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.
💊

What it tests

  • 3D printed patient specific model
  • Conventional
  • Brainlab navigation system
📍

Where

2 sites
Ain shams university hospitals, department of plastic, burn and maxillofacial surgery
Cairo, Egypt
Ain shams university hospitals
Cairo, Egypt
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
🛡️

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it — not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use · Privacy