Naso-Orbito-EthmoidalPhase 4NCT07791095
REDUCTION ACCURACY IN NASO-ORBITO-ETHMOIDAL FRACTURES AFTER VIRTUAL REDUCTION AND FIXATION USING PRE-ADAPTED MINIPLATES
A Phase 4 study testing pre-adapted titanium miniplates based on a virtually reduced 3D model in people with Naso-Orbito-Ethmoidal and Fractures, run by Alexandria University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Naso-Orbito-Ethmoidal, Fractures
- What is being tested?
- pre-adapted titanium miniplates based on a virtually reduced 3D model
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2025to 1 Oct 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Active Infection or Heavily Contaminated Open Fractures.
- Old Fractures.
- Patients unsuitable or unable to tolerate surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: REDUCTION ACCURACY IN NASO-ORBITO-ETHMOIDAL FRACTURES AFTER VIRTUAL REDUCTION AND FIXATION USING PRE-ADAPTED MINIPLATES (A CLINICAL 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.
- Conditions
- Naso-Orbito-Ethmoidal, Fractures
- Being tested
- pre-adapted titanium miniplates based on a virtually reduced 3D model
- Keywords
- Virtual reduction
- Medical subject headings
- Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Patients with Naso-orbito-ethmoidal (NOE) fractures | Experimental | Not described Receives: Device: pre-adapted titanium miniplates based on a virtually reduced 3D model |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Immediately after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2026
- Study start1 Nov 2025
- Primary completion30 Sep 2026
- Study completion1 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Naso-Orbito-EthmoidalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07791095
- Sponsor's protocol ID
- 1187-11/2025
- Status last verified
- Aug 2026
- First submitted
- 25 Aug 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REDUCTION ACCURACY IN NASO-ORBITO-ETHMOIDAL FRACTURES AFTER VIRTUAL REDUCTION AND FIXATION USING PRE-ADAPTED MINIPLATES (A CLINICAL TRIAL)
- ClinicalTrials.gov ID
- NCT07791095
- Acronym / sponsor ID
- 1187-11/2025
- Conditions
- Naso-Orbito-Ethmoidal, Fractures
- Keywords
- Virtual reduction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- 30 Sep 2026 (actual)
- Study completion
- 1 Oct 2026 (actual)
- First posted
- 27 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Naso-orbito-ethmoidal (NOE) fractures | Experimental | Device: pre-adapted titanium miniplates based on a virtually reduced 3D model |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- Active Infection or Heavily Contaminated Open Fractures.
- Old Fractures.
- Patients unsuitable or unable to tolerate surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pre-adapted titanium miniplates based on a virtually reduced 3D modelNaso-orbito-ethmoidal (NOE) treated using pre-adapted titanium miniplates based on a virtually reduced 3D model | Device | Patients with Naso-orbito-ethmoidal (NOE) fractures |
Primary outcome
Intercanthal distance
Time frame: 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
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- Individual participant dataSharing planned: Yes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing pre-adapted titanium miniplates based on a virtually reduced 3D model in people with Naso-Orbito-Ethmoidal and Fractures, run by Alexandria University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intercanthal distance (time frame: Immediately after the surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026.