Blow-Out FracturesNCT06369129
Accuracy& Orbital Volume Using Patient Specific Titanium Implant Vs Zirconia for Orbital Floor Reconstruction
A study testing Orbital floor reconstruction with Patient Specific Zirconia Implant and Orbital floor reconstruction with Patient Specific Titanium Implant in people with Blow-Out Fractures and Orbital Fractures, run by Cairo University at 1 site in Egypt.
Trial summary
Comparative study used to assess if the patient specific zirconia implant will provide better accuracy, intraoperative adaptability, precise orbital volume and soft tissue reaction with more cost effectiveness than the patient specific titanium implants in orbital floor reconstruction after blow out fractures . Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Blow-Out Fractures, Orbital Fractures, Orbital Floor Fracture
- What is being tested?
- Orbital floor reconstruction with Patient Specific Zirconia Implant and Orbital floor reconstruction with Patient Specific Titanium Implant
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 6 Apr 2024to Aug 2025
- 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients with blow out fracture isolated and / or combined with other fracture.
- Age group: from 18 to 60 years old
- No sex predilection
- Patients with no contraindications to surgical intervention.
- Patients willing for the surgical procedure and follow-up, with an informed consent.
Who cannot join
- Medically compromised patients.
- Patients with history of previous orbital reconstruction surgery.
- Uncooperative patients.
- Patients with systemic contraindication to general anesthesia.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Cairo University
Cairo, 11511
OLA A. ELMORSY, PHD, 00201141234877, dr.ola.elmorsy@gmail.com
About this study
Official title: Assessment of Accuracy and Orbital Volume Using Patient Specific Titanium Implant Vs Patient Specific Zirconia Implant for Orbital Floor Reconstruction in Blowout Fractures A Randomized Clinical Trial: Comparative Study
Comparative study used to assess if the patient specific zirconia implant will provide better accuracy, intraoperative adaptability, precise orbital volume and soft tissue reaction with more cost effectiveness than the patient specific titanium implants in orbital floor reconstruction after blow out fractures .
Read the detailed description
Patients of both groups will be subjected to:
- Case history including personal data, medical, surgical history and family history.
- A full examination of the cranial and maxillofacial skeleton and soft tissue .
- Evaluation of Visual Functions
- Ophthalmologic consultation and clearance
- Radiographic examination: CT scan
- All DICOM data will be imported to the surgical planning software.
Virtual planning:
- A midsagittal plane will be constructed then the normal orbit will be mirrored to the affected side.
- The mirrored orbital floor will be meshed with 1.6 mm holes then its peripheries will be extended downwards by 3 mm and meshed also in order to accommodate the fixation.
- The designed part will be subtracted then exported in Stereolithography (STL) format to be fabricated . The surgery will be done under General anesthesia and undertaken within 14 days to prevent fibrosis. Can be delayed 24-72 hours to allow the edema to subside before undertaking surgery. Intervention Group: -
- The STL file will be milled from zirconium and then will be ready for sterilization and intraoperative fixation
- A transconjunctival incision will be done to allow for good exposure that optimizes visualization of the orbital floor during the repair and insertion and fixation of the patient specific zirconia implant. Control Group: -
- The STL file be milled from grade 4 titanium and then will be ready for sterilization and intraoperative fixation with the same surgical steps. Follow up: All patients will be examined clinically and radiographically, during postoperative 1st and 2nd week . Only one postoperative CT scan will be done after 2 weeks.
- Being tested
- Orbital floor reconstruction with Patient Specific Zirconia Implant, Orbital floor reconstruction with Patient Specific Titanium Implant
- Medical subject headings
- Orbital Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Orbital floor reconstruction with Patient Specific Zirconia ImplantProcedure or surgery
Orbital floor reconstruction with Patient Specific Zirconia Implant will be done
Orbital floor reconstruction with Patient Specific Titanium ImplantProcedure or surgery
Orbital floor reconstruction with Patient Specific Titanium Implant will be done
| Study group | Role | What they receive |
|---|---|---|
| Orbital floor reconstruction with Patient Specific Zirconia Implant | Experimental | Orbital floor reconstruction with Patient Specific Zirconia Implant will be done Receives: Procedure: Orbital floor reconstruction with Patient Specific Zirconia Implant |
| Orbital floor reconstruction with Patient Specific Titanium Implant | Active comparator | Orbital floor reconstruction with Patient Specific Titanium Implant will be done. Receives: Procedure: Orbital floor reconstruction with Patient Specific Titanium Implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Orbital Volume
will be measured with CT scan in mm3
Measured: immediately post operative
Secondary outcomes (3)
Accuracy of the patient specific implant in the orbital floor reconstruction
will be measured with CT scan with superimposition of the preoperative CT scan and the mirrored image and the post operative CT scan . The difference will be measured by mm
Measured: immediately post operative
Cost effectiveness
will compare between the prices of the patient specific implants the titanium and the zirconia and financial record will be kept with that in United states dollar . By the end of the study and comparison will be done to check which one was more cost effective
Measured: through study completion, an average of 1 year
Patient satisfaction
will be assessed by a Questionnaire using Visual analogue scale , highest score will be more satisficed .The score is minimum 1 and maximum 10.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2024
- Study start6 Apr 2024
- Primary completionAug 2025 (estimated)
- Study completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blow-Out 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized clinical trial. * Parallel group study. * A trial will be carried out in hospital of Oral and Maxillofacial surgery department - Faculty of Oral and Dental Medicine - Cairo University . * Equal randomization : participants with equal probabilities for intervention. * Positive controlled : Both groups receiving treatment.
- 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, Ola Alaa El-Din Abd El-Monem Mohamed, Cairo University
- Investigators
- OLA A. ELMORSY, PHD, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06369129
- Sponsor's protocol ID
- CEBD-CU-2024-06-16
- Status last verified
- Apr 2024
- First submitted
- 6 Apr 2024
- Last updated
- 17 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Accuracy and Orbital Volume Using Patient Specific Titanium Implant Vs Patient Specific Zirconia Implant for Orbital Floor Reconstruction in Blowout Fractures A Randomized Clinical Trial: Comparative Study
- ClinicalTrials.gov ID
- NCT06369129
- Acronym / sponsor ID
- CEBD-CU-2024-06-16
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 6 Apr 2024 (actual)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 16 Apr 2024 (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.
Comparative study used to assess if the patient specific zirconia implant will provide better accuracy, intraoperative adaptability, precise orbital volume and soft tissue reaction with more cost effectiveness than the patient specific titanium implants in orbital floor reconstruction after blow out fractures .
Detailed description
Patients of both groups will be subjected to:
- Case history including personal data, medical, surgical history and family history.
- A full examination of the cranial and maxillofacial skeleton and soft tissue .
- Evaluation of Visual Functions
- Ophthalmologic consultation and clearance
- Radiographic examination: CT scan
- All DICOM data will be imported to the surgical planning software.
Virtual planning:
- A midsagittal plane will be constructed then the normal orbit will be mirrored to the affected side.
- The mirrored orbital floor will be meshed with 1.6 mm holes then its peripheries will be extended downwards by 3 mm and meshed also in order to accommodate the fixation.
- The designed part will be subtracted then exported in Stereolithography (STL) format to be fabricated . The surgery will be done under General anesthesia and undertaken within 14 days to prevent fibrosis. Can be delayed 24-72 hours to allow the edema to subside before undertaking surgery. Intervention Group: -
- The STL file will be milled from zirconium and then will be ready for sterilization and intraoperative fixation
- A transconjunctival incision will be done to allow for good exposure that optimizes visualization of the orbital floor during the repair and insertion and fixation of the patient specific zirconia implant. Control Group: -
- The STL file be milled from grade 4 titanium and then will be ready for sterilization and intraoperative fixation with the same surgical steps. Follow up: All patients will be examined clinically and radiographically, during postoperative 1st and 2nd week . Only one postoperative CT scan will be done after 2 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A randomized clinical trial. * Parallel group study. * A trial will be carried out in hospital of Oral and Maxillofacial surgery department - Faculty of Oral and Dental Medicine - Cairo University . * Equal randomization : participants with equal probabilities for intervention. * Positive controlled : Both groups receiving treatment.
| Arm | Type | Receives |
|---|---|---|
| Orbital floor reconstruction with Patient Specific Zirconia Implant | Experimental | Procedure: Orbital floor reconstruction with Patient Specific Zirconia ImplantOrbital floor reconstruction with Patient Specific Zirconia Implant will be done |
| Orbital floor reconstruction with Patient Specific Titanium Implant | Active comparator | Procedure: Orbital floor reconstruction with Patient Specific Titanium ImplantOrbital floor reconstruction with Patient Specific Titanium Implant will be done. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patients with blow out fracture isolated and / or combined with other fracture.
- Age group: from 18 to 60 years old
- No sex predilection
- Patients with no contraindications to surgical intervention.
- Patients willing for the surgical procedure and follow-up, with an informed consent.
Key exclusion criteria (4 listed)
- Medically compromised patients.
- Patients with history of previous orbital reconstruction surgery.
- Uncooperative patients.
- Patients with systemic contraindication to general anesthesia.
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 |
|---|---|---|
| Orbital floor reconstruction with Patient Specific Zirconia ImplantOrbital floor reconstruction with Patient Specific Zirconia Implant will be done | Procedure or surgery | Orbital floor reconstruction with Patient Specific Zirconia Implant |
| Orbital floor reconstruction with Patient Specific Titanium ImplantOrbital floor reconstruction with Patient Specific Titanium Implant will be done | Procedure or surgery | Orbital floor reconstruction with Patient Specific Titanium Implant |
Primary outcome
Orbital Volume
Time frame: immediately post operative
will be measured with CT scan in mm3
3 secondary outcomes
Accuracy of the patient specific implant in the orbital floor reconstruction
Time frame: immediately post operative
Cost effectiveness
Time frame: through study completion, an average of 1 year
Patient satisfaction
Time frame: through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2024.
- Individual participant dataSharing planned: No
Related trials for Blow-Out Fractures
Active, not recruitingObservational study
Orbital Fractures Registry
Orbital Fractures, Blow Out Fracture of Orbit
Active, not recruiting
Endoscopically Assisted Management of Maxillofacial Fractures: A Prospective Study on Efficacy and Outcomes
Maxillofacial Injuries, Maxillofacial Trauma
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.
OLA A. ELMORSY, PHD principal investigator
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 Orbital floor reconstruction with Patient Specific Zirconia Implant and Orbital floor reconstruction with Patient Specific Titanium Implant in people with Blow-Out Fractures and 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 5 inclusion and 4 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 Apr 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact OLA A. ELMORSY, PHD (00201141234877, dr.ola.elmorsy@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Orbital Volume (time frame: immediately post operative). 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 Apr 2024.