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

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

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07791095

Enrollment

Registered

2026-08-27

Start date

2025-11-01

Completion date

2026-10-01

Last updated

2026-08-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Naso-Orbito-Ethmoidal

Keywords

Virtual reduction

Brief 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.

Interventions

DEVICEpre-adapted titanium miniplates based on a virtually reduced 3D model

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

Egypt

Contacts

CONTACTRim Ismail, M.D

Reem.ismail.dent@alexu.edu.eg01501987877

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 28, 2026