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

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorAlexandria University

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • 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

Treatment groups

15 Participants
are divided into 1 treatment group
Group A: Patients with Naso-orbito-ethmoidal (NOE) fracturesExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Immediately after the surgery
2

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.

Time frame
Immediately after the surgery

Secondary outcomes

Other outcomes

Sponsors and contacts

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