NCT07791095

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_4

Timeline
1mo left

Started Nov 2025

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress90%
Nov 2025Oct 2026

Study Start

First participant enrolled

November 1, 2025

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

August 25, 2026

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 27, 2026

Completed
5 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Last Updated

August 27, 2026

Status Verified

August 1, 2026

Enrollment Period

10 months

First QC Date

August 25, 2026

Last Update Submit

August 25, 2026

Conditions

Naso-Orbito-Ethmoidal

Keywords

Virtual reduction

Outcome Measures

Primary Outcomes (2)

  • 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.

    Immediately after the surgery

  • 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.

    Immediately after the surgery

Study Arms (1)

Patients with Naso-orbito-ethmoidal (NOE) fractures

EXPERIMENTAL
Device: pre-adapted titanium miniplates based on a virtually reduced 3D model

Interventions

pre-adapted titanium miniplates based on a virtually reduced 3D modelDEVICE

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

Patients with Naso-orbito-ethmoidal (NOE) fractures

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of dentistry, Alexandria university

Alexandria, 21523, Egypt

RECRUITING

Central Study Contacts

Rim Ismail, M.D

CONTACT

01501987877Reem.ismail.dent@alexu.edu.eg

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 25, 2026

First Posted

August 27, 2026

Study Start

November 1, 2025

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

October 1, 2026

Last Updated

August 27, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will share

Locations

EG(1)