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NCT07882121
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
Conditions: Orbital Fractures, Unilateral, Recent
Sex: All
Ages: 18 Years – 55 Years
Healthy volunteers: No
Phase: NA
Enrollment: 30
Sponsor: Ain Shams University
Location: Ain shams university hospitals, department of plastic, burn and maxillofacial surgery Cairo Abbasia
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
Eligibility Criteria
Inclusion Criteria:
* Fracture orbital wall:
* Timing: Recent (\ 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.
Source: ClinicalTrials.gov (NCT07882121). StuddyBuddy aggregates publicly available trial information.