Orbital FracturesNCT04271137
Correction of Enophthalmos and Orbital Volume Using Pre-bent Mesh Versus 3d Printed Onlay in Orbital Fracture Cases
A study testing 3D printed PEEK onlay and Pre-bent orbital mesh in people with Orbital Fractures and Enophthalmos, run by Cairo University at 1 site in Egypt.
Trial summary
this study evaluates the post-surgical correction of enophthalmos and orbital volume using 3D printed only versus pre-bent titanium mesh in blow-out fracture cases Read more about this study
- Who is it for?
- Ages 17 years and older
- Conditions the study is for
- Orbital Fractures, Enophthalmos, Periorbital Fracture
- What is being tested?
- 3D printed PEEK onlay and Pre-bent orbital mesh
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2020to 1 Mar 2021
- 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 17 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Adult patients (≤17 years old).
- Blow-out Orbital Fracture.
- Unilateral Orbital Trauma.
- Enophthalmos (≤ 2 mm).
- Patients with contralateral healthy, non-surgically operated orbit.
Who cannot join
- Young Patients (> 17 years old).
- Patients with Systemic diseases.
- Bilateral Orbital Trauma.
- Enophthalmos (>2 mm).
- Patients whom cannot tolerate follow up intervals.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Dentistry - Cairo University
Cairo, 11553
Khalid Amr, PhD, khaledamr82@gmail.com
About this study
Official title: Evaluation of Orbital Reconstruction Using Patient Specific 3-D Printed Onlay Versus Pre-Bent Titanium Mesh
this study evaluates the post-surgical correction of enophthalmos and orbital volume using 3D printed only versus pre-bent titanium mesh in blow-out fracture cases
Read the detailed description
Many materials had been used in reconstruction of blow out fractures, the aim of this study is to evaluate the enophthalmos correction and orbital volume restoration using 3D printed onlay versus pre-bent titanium mesh
- Conditions
- Orbital Fractures, Enophthalmos, Periorbital Fracture
- Being tested
- 3D printed PEEK onlay, Pre-bent orbital mesh
- Keywords
- 3d printed onlay, PEEK, orbital mesh, computer-guided surgery
- Medical subject headings
- Orbital Fractures, Enophthalmos
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D printed PEEK onlayCombination product
3d computer-designed Orbital onlay
Pre-bent orbital meshCombination product
Pre-bent orbital mesh on 3d printed template
| Study group | Role | What they receive |
|---|---|---|
| Orbital fractues | Other | Orbital fractures Receives: Combination Product: 3D printed PEEK onlay; Combination Product: Pre-bent orbital mesh |
What is being measured
The primary outcome is the main question the study is designed to answer.
Enophthalmos
CT based exphthalmometery - corneal projection from lateral orbital rim measured in millimeters
Measured: 1 week post-operative
Enophthalmos
CT based - corneal projection from lateral orbital rim measured in millimeters
Measured: 1 year post-operative
Secondary outcomes (2)
Orbital volume
Change in orbital volume ratio on CT in centimeter cubic
Measured: one week post-operative
Implant position accuracy
Superimposition of pre- and post-operative 3d bony structures on CT in 2d views of the x-ray
Measured: One week post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2020
- Study start1 Mar 2020 (estimated)
- Primary completion1 Jan 2021 (estimated)
- Study completion1 Mar 2021 (estimated)
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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Salah, Cairo University
- Investigators
- Ahmed Mohamed, PhD, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04271137
- Sponsor's protocol ID
- OMFS 3 3 10
- Status last verified
- Feb 2020
- First submitted
- 10 Feb 2020
- Last updated
- 17 Feb 2020
- 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 17 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Orbital Reconstruction Using Patient Specific 3-D Printed Onlay Versus Pre-Bent Titanium Mesh
- ClinicalTrials.gov ID
- NCT04271137
- Acronym / sponsor ID
- OMFS 3 3 10
- Conditions
- Orbital Fractures, Enophthalmos, Periorbital Fracture
- Keywords
- 3d printed onlay, PEEK, orbital mesh, computer-guided surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Mar 2020 (estimated)
- Primary completion
- 1 Jan 2021 (estimated)
- Study completion
- 1 Mar 2021 (estimated)
- First posted
- 17 Feb 2020 (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 evaluates the post-surgical correction of enophthalmos and orbital volume using 3D printed only versus pre-bent titanium mesh in blow-out fracture cases
Detailed description
Many materials had been used in reconstruction of blow out fractures, the aim of this study is to evaluate the enophthalmos correction and orbital volume restoration using 3D printed onlay versus pre-bent titanium mesh
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Orbital fractues | Other | Combination Product: 3D printed PEEK onlay, Combination Product: Pre-bent orbital meshOrbital fractures |
Who may qualify
- Ages
- 17 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Adult patients (≤17 years old).
- Blow-out Orbital Fracture.
- Unilateral Orbital Trauma.
- Enophthalmos (≤ 2 mm).
- Patients with contralateral healthy, non-surgically operated orbit.
Key exclusion criteria (5 listed)
- Young Patients (> 17 years old).
- Patients with Systemic diseases.
- Bilateral Orbital Trauma.
- Enophthalmos (>2 mm).
- Patients whom cannot tolerate follow up intervals.
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 |
|---|---|---|
| 3D printed PEEK onlay3d computer-designed Orbital onlay | Combination product | Orbital fractues |
| Pre-bent orbital meshPre-bent orbital mesh on 3d printed template | Combination product | Orbital fractues |
Primary outcome
Enophthalmos
Time frame: 1 week post-operative
CT based exphthalmometery - corneal projection from lateral orbital rim measured in millimeters
Enophthalmos
Time frame: 1 year post-operative
CT based - corneal projection from lateral orbital rim measured in millimeters
2 secondary outcomes
Orbital volume
Time frame: one week post-operative
Implant position accuracy
Time frame: One week post-operative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2020.
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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.
Ahmed Mohamed, PhD study director
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3D printed PEEK onlay and Pre-bent orbital mesh in people with Orbital Fractures and Enophthalmos, 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 5 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 17 Feb 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Khalid Amr, PhD (+201006029031, khaledamr82@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Enophthalmos (time frame: 1 week post-operative). 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 17 Feb 2020.