Orbital FracturesNCT05439512
Orbital Floor Fracture Repair by Titanium Mesh Via Transantral Approach.
A study testing transantral orbital floor reconstruction by titanium mesh in people with Orbital Fractures, run by Cairo University at 1 site in Egypt.
Trial summary
The aim of the study is to evaluate the feasibility of CAD/CAM osteosynthesis mesh through a transantral surgical approach in the Repair of orbital floor fractures by means of clinical and radiographic findings. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Orbital Fractures
- What is being tested?
- transantral orbital floor reconstruction by titanium mesh
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2021to 27 Jul 2023
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with recent unilateral orbital floor fracture indicated for internal reconstruction -
- (isolated or in combination with other facial fractures)
- with existing or estimated enophthalmos based on radiographs and a contra-lateral healthy non-operated orbit.
Who cannot join
- Delayed cases (more than 2 weeks)
- previously operated cases
- bilateral orbital floor fracture.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility of Patient-specific Titanium Mesh Via A Transantral Approach for Repair of Orbital Floor Fractures.
The aim of the study is to evaluate the feasibility of CAD/CAM osteosynthesis mesh through a transantral surgical approach in the Repair of orbital floor fractures by means of clinical and radiographic findings.
Read the detailed description
A CAD/CAM osteosynthesis mesh through a transantral approach should assumingly provide accurate reconstruction of the orbital volume and anatomy while eliminating the usual morbidity of lower eyelid approaches during orbital reconstruction.
- Conditions
- Orbital Fractures
- Being tested
- transantral orbital floor reconstruction by titanium mesh
- Medical subject headings
- Orbital Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transantral orbital floor reconstruction by titanium meshProcedure or surgery
Also called trans antral orbital floor reconstruction
reconstruction of orbital floor fracture by patient specific titanium mesh
| Study group | Role | What they receive |
|---|---|---|
| orbital floor fracture | Experimental | orbital floor fracture Receives: Procedure: transantral orbital floor reconstruction by titanium mesh |
What is being measured
The primary outcome is the main question the study is designed to answer.
enophthamus
will calculate the amount of alteration and quantity of Enophthalmos by mean of a Post-Op Soft window CT scan in mm
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2022
- Study start1 Aug 2021
- Primary completion5 Jun 2023
- Study completion27 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orbital FracturesStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aliaa Khalaf Abd Ellatief Mohamed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05439512
- Sponsor's protocol ID
- 3310
- Status last verified
- Feb 2024
- First submitted
- 26 Jun 2022
- Last updated
- 7 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Patient-specific Titanium Mesh Via A Transantral Approach for Repair of Orbital Floor Fractures.
- ClinicalTrials.gov ID
- NCT05439512
- Acronym / sponsor ID
- 3310
- Conditions
- Orbital Fractures
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 5 Jun 2023 (actual)
- Study completion
- 27 Jul 2023 (actual)
- First posted
- 30 Jun 2022 (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.
The aim of the study is to evaluate the feasibility of CAD/CAM osteosynthesis mesh through a transantral surgical approach in the Repair of orbital floor fractures by means of clinical and radiographic findings.
Detailed description
A CAD/CAM osteosynthesis mesh through a transantral approach should assumingly provide accurate reconstruction of the orbital volume and anatomy while eliminating the usual morbidity of lower eyelid approaches during orbital reconstruction.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| orbital floor fracture | Experimental | Procedure: transantral orbital floor reconstruction by titanium meshorbital floor fracture |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with recent unilateral orbital floor fracture indicated for internal reconstruction -
- (isolated or in combination with other facial fractures)
- with existing or estimated enophthalmos based on radiographs and a contra-lateral healthy non-operated orbit.
Key exclusion criteria (3 listed)
- Delayed cases (more than 2 weeks)
- previously operated cases
- bilateral orbital floor fracture.
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 |
|---|---|---|
| transantral orbital floor reconstruction by titanium meshAlso: trans antral orbital floor reconstructionreconstruction of orbital floor fracture by patient specific titanium mesh | Procedure or surgery | orbital floor fracture |
Primary outcome
enophthamus
Time frame: 6 months
will calculate the amount of alteration and quantity of Enophthalmos by mean of a Post-Op Soft window CT scan in mm
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 7 Feb 2024.
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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 study testing transantral orbital floor reconstruction by titanium mesh in people with Orbital Fractures, run by Cairo 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 3 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 7 Feb 2024. 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.
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?
enophthamus (time frame: 6 months). 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 7 Feb 2024.