REDUCTION ACCURACY IN NASO-ORBITO-ETHMOIDAL FRACTURES AFTER VIRTUAL REDUCTION AND FIXATION USING PRE-ADAPTED MINIPLATES

NCT07791095 — Phase 4, Completed, 15 participants, Alexandria University

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REDUCTION ACCURACY IN NASO-ORBITO-ETHMOIDAL FRACTURES AFTER VIRTUAL REDUCTION AND FIXATION USING PRE-ADAPTED MINIPLATES (A CLINICAL TRIAL)

Registry	NCT07791095
Status	Completed
Phase	Phase 4
Study type	Interventional; na, single group, masking: none, treatment
Enrollment	15 (Actual)
Sponsor	Alexandria University (Other)
Conditions	Naso-Orbito-Ethmoidal, Fractures
Interventions	pre-adapted titanium miniplates based on a virtually reduced 3D model (Device)
Dates	start 2025-11-01, primary completion 2026-09-30, completion 2026-10-01, first posted 2026-08-27, last updated 2026-10-21
Locations	1 site in Egypt

-Summary

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.

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+Arms and interventions

Arm	Type	Interventions	Description
Patients with Naso-orbito-ethmoidal (NOE) fractures	Experimental	Device: pre-adapted titanium miniplates based on a virtually reduced 3D model

pre-adapted titanium miniplates based on a virtually reduced 3D model (Device): Naso-orbito-ethmoidal (NOE) treated using pre-adapted titanium miniplates based on a virtually reduced 3D model

+Outcome measures

Primary outcomes

Intercanthal distance [Immediately after the surgery]: 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 [Immediately after the surgery]: 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.

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* 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).
* Ability to attend for follow-up.

Exclusion Criteria:

* Active Infection or Heavily Contaminated Open Fractures.
* Old Fractures.
* Patients unsuitable or unable to tolerate surgery.

+Locations (1)

Facility	City	Country	Status
Faculty of dentistry, Alexandria university	Alexandria	Egypt