Large Orbital Floor FractureNCT06661785
Interlocking Polyetheretherketone Implants for Orbital Floor Reconstruction
A study testing large orbital floor fracture in people with Large Orbital Floor Fracture, run by Tanta University at 1 site in Egypt.
Trial summary
Patients with large orbital floor fracture were reconstructed with interlocking polyetheretherketone patient-specific implant and will be evaluated clinically and radiographically Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Large Orbital Floor Fracture
- What is being tested?
- large orbital floor fracture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Apr 2024to 15 Feb 2026
- 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
- No healthy volunteers
- Adult
Who may be able to join
- Patients with large orbital blow out fracture either isolated or combined with other fracture
- Patients willing for surgical operation and follow up
- Patients with no contraindications for surgical intervention
Who cannot join
- Patients who are not fit for G.A
- Uncooperative patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Interlocking Polyetheretherketone Patient-Specific Implants for Orbital Floor Reconstruction
Patients with large orbital floor fracture were reconstructed with interlocking polyetheretherketone patient-specific implant and will be evaluated clinically and radiographically
Read the detailed description
Twenty two patients with large orbital floor fracture will be included in this study. Patients will be received, examined and managed at the Oral \& Maxillofacial Surgery Department, Faculty of Dentistry, Tanta University. Full clinical examination and radiographic examination using multi axial C.T Scan for proper diagnosis and treatment planning. DICOM files will be imported into surgical planning software and used for fabrication of interlocking polyetheretherketone patient specific implant which will be ready for sterilization and insertion. After written informed consent from the patient, the surgery will be done under G.A, either infraorbital or transconjunctival incision will be done according to the case. Follow up: All patients will be examined clinically for hypoglobus, enophthalmos, ocular motility and diplopia during 2nd week, 1st month and 6 months \& radiographically for orbital volume immediately and 6 months postoperatively
- Conditions
- Large Orbital Floor Fracture
- Being tested
- large orbital floor fracture
- Keywords
- orbital reconstruction, Interlocking PEEK, Patient specific implant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
large orbital floor fractureProcedure or surgery
Twenty two patients with large orbital floor fracture will be reconstructed with interlocking polyetheretherketone patient-specific implant
| Study group | Role | What they receive |
|---|---|---|
| Interlocking polyetheretherketone patient specific implant for orbital floor reconstruction | Experimental | This study is conducted on twenty two patients with unilateral large orbital floor fracture reconstructed with interlocking polyetheretherketone patient specific implant Receives: Procedure: large orbital floor fracture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hypoglobus
It is the downward displacement of the eyeball of affected eye. It is measured by drawing imaginary line horizontally across the patient's inter-pupillary axis and determine if the pupil of the affected eye is lower or not
Measured: 2 weeks
Enophthalmos
It is defined as the posterior displacement of the eyeball within the orbit. It was measured by the aid of exophthalmometer. Assessment is consisting of four grades as follow:
grade 0:no enophthalmos grade 1:mild enophthalmos(less than 1 mm) grade 2:moderate enophthalmos(from 1 to 2 mm) grade 3:severe enophthalmos(over 2 mm)
Measured: 2 weeks
Orbital volume
C.T. images of the patient are imported in DICOM format into the automatic orbital analysis software and the orbital volume of both orbital cavities are measured
Measured: 2 weeks
Ocular motility
It is done by asking the patient to follow a moving target into the diagnostic positions of gaze, observing the extent of movement of each eye. The amount of limitation of movement is classified as:
grade 1:slight limitation grade 2:moderate limitation grade 3:marked limitation grade 4:no movement
Measured: 2 weeks
Diplopia
It is defined as perception of two images of the same object in visual space. It is assessed if it is present in primary position of gaze or in secondary position of gaze
Measured: 2 weeks
Secondary outcomes (5)
Hypoglobus
It is the downward displacement of the eyeball of affected eye. It is measured by drawing imaginary line horizontally across the patient's inter-pupillary axis and determine if the pupil of the affected eye is lower or not
Measured: 6 months
Enophthalmos
It is defined as the posterior displacement of the eyeball within the orbit. It was measured by the aid of exophthalmometer. Assessment is consisting of four grades as follow: grade 0:no enophthalmos grade 1:mild enophthalmos(less than 1 mm) grade 2:moderate enophthalmos(from 1 to 2 mm) grade 3:severe enophthalmos(over 2 mm)
Measured: 6 months
Orbital volume
C.T. images of the patient are imported in DICOM format into the automatic orbital analysis software and the orbital volume of both orbital cavities are measured
Measured: 6 months
Ocular motility
It is done by asking the patient to follow a moving target into the diagnostic positions of gaze, observing the extent of movement of each eye. The amount of limitation of movement is classified as: grade 1:slight limitation grade 2:moderate limitation grade 3:marked limitation grade 4:no movement
Measured: 6 months
Diplopia
It is defined as perception of two images of the same object in visual space. It is assessed if it is present in primary position of gaze or in secondary position of gaze
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 posted28 Oct 2024
- Study start25 Apr 2024
- Primary completion25 Jul 2024
- Study completion15 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Large Orbital Floor FractureStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maram Nashaat Breshah, Tanta University
- Investigators
- Maram N Breshah, Lecturer, Principal investigator, Tanta University, EgyptRafic R Beder, Prof, Principal investigator, Tanta University, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06661785
- Sponsor's protocol ID
- #R-OS-12-22-3
- Status last verified
- Oct 2024
- First submitted
- 22 Oct 2024
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interlocking Polyetheretherketone Patient-Specific Implants for Orbital Floor Reconstruction
- ClinicalTrials.gov ID
- NCT06661785
- Acronym / sponsor ID
- #R-OS-12-22-3
- Conditions
- Large Orbital Floor Fracture
- Keywords
- orbital reconstruction, Interlocking PEEK, Patient specific implant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 25 Apr 2024 (actual)
- Primary completion
- 25 Jul 2024 (actual)
- Study completion
- 15 Feb 2026 (actual)
- First posted
- 28 Oct 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.
Patients with large orbital floor fracture were reconstructed with interlocking polyetheretherketone patient-specific implant and will be evaluated clinically and radiographically
Detailed description
Twenty two patients with large orbital floor fracture will be included in this study. Patients will be received, examined and managed at the Oral \& Maxillofacial Surgery Department, Faculty of Dentistry, Tanta University. Full clinical examination and radiographic examination using multi axial C.T Scan for proper diagnosis and treatment planning. DICOM files will be imported into surgical planning software and used for fabrication of interlocking polyetheretherketone patient specific implant which will be ready for sterilization and insertion. After written informed consent from the patient, the surgery will be done under G.A, either infraorbital or transconjunctival incision will be done according to the case. Follow up: All patients will be examined clinically for hypoglobus, enophthalmos, ocular motility and diplopia during 2nd week, 1st month and 6 months \& radiographically for orbital volume immediately and 6 months postoperatively
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Interlocking polyetheretherketone patient specific implant for orbital floor reconstruction | Experimental | Procedure: large orbital floor fractureThis study is conducted on twenty two patients with unilateral large orbital floor fracture reconstructed with interlocking polyetheretherketone patient specific implant |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients with large orbital blow out fracture either isolated or combined with other fracture
- Patients willing for surgical operation and follow up
- Patients with no contraindications for surgical intervention
Key exclusion criteria (2 listed)
- Patients who are not fit for G.A
- Uncooperative patients
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 |
|---|---|---|
| large orbital floor fractureTwenty two patients with large orbital floor fracture will be reconstructed with interlocking polyetheretherketone patient-specific implant | Procedure or surgery | Interlocking polyetheretherketone patient specific implant for orbital floor reconstruction |
Primary outcome
Hypoglobus
Time frame: 2 weeks
It is the downward displacement of the eyeball of affected eye. It is measured by drawing imaginary line horizontally across the patient's inter-pupillary axis and determine if the pupil of the affected eye is lower or not
Enophthalmos
Time frame: 2 weeks
It is defined as the posterior displacement of the eyeball within the orbit. It was measured by the aid of exophthalmometer. Assessment is consisting of four grades as follow: grade 0:no enophthalmos grade 1:mild enophthalmos(less than 1 mm) grade 2:moderate enophthalmos(from 1 to 2 mm) grade 3:severe enophthalmos(over 2 mm)
Orbital volume
Time frame: 2 weeks
C.T. images of the patient are imported in DICOM format into the automatic orbital analysis software and the orbital volume of both orbital cavities are measured
Ocular motility
Time frame: 2 weeks
It is done by asking the patient to follow a moving target into the diagnostic positions of gaze, observing the extent of movement of each eye. The amount of limitation of movement is classified as: grade 1:slight limitation grade 2:moderate limitation grade 3:marked limitation grade 4:no movement
Diplopia
Time frame: 2 weeks
It is defined as perception of two images of the same object in visual space. It is assessed if it is present in primary position of gaze or in secondary position of gaze
5 secondary outcomes
Hypoglobus
Time frame: 6 months
Enophthalmos
Time frame: 6 months
Orbital volume
Time frame: 6 months
Ocular motility
Time frame: 6 months
Diplopia
Time frame: 6 months
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 25 Jun 2026.
- Individual participant dataSharing planned: No
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.
Maram N Breshah, Lecturer principal investigator
Tanta University, Egypt
Rafic R Beder, Prof principal investigator
Tanta University, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing large orbital floor fracture in people with Large Orbital Floor Fracture, run by Tanta 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 2 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 25 Jun 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.
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?
Hypoglobus (time frame: 2 weeks). The study lists 5 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 25 Jun 2026; AzTrials last refreshed its copy on 27 Oct 2026.