About this trial
This study aims to assess the reduction accuracy of Naso-orbito-ethmoidal (NOE) fractures using pre-adapted titanium miniplates based on a virtually reduced 3D model.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
CT-confirmed naso-orbito-ethmoidal (NOE) fracture (unilateral or bilateral) requiring operative fixation (ORIF).
Acute fractures with injury-to-definitive surgery ≤ 14 days.
Skeletally mature patients (above 18 years).
Medically fit for general anesthesia and craniofacial surgery (ASA1).
Disqualifiers
Active Infection or Heavily Contaminated Open Fractures.
Old Fractures.
Patients unsuitable or unable to tolerate surgery.
Trial design
Single group
Treatments tested in this trial
pre-adapted titanium miniplates based on a virtually reduced 3D model
DeviceNaso-orbito-ethmoidal (NOE) treated using pre-adapted titanium miniplates based on a virtually reduced 3D model
Treatment groups
Trial outcomes
Primary outcomes
Intercanthal distance
Intercanthal distance is measured by seating the patient upright with the head in neutral position and eyes in primary gaze, then placing a rigid ruler horizontally across the nasal bridge to measure the linear distance between the medial canthi, recording the value in millimeters.
Reduction accuracy
To evaluate the success of fracture reduction and fixation, a baseline CT scan will be acquired for each patient It will then be superimposed on the virtual plan model using MIMICS software.
Sponsors and contacts
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