Zygomatic FracturesNCT03484676
Adequacy of One Point Fixation of Displaced Zygomatic Complex Fracture
A study testing Titinium in people with Zygomatic Fractures, run by Cairo University.
Trial summary
Patients with unilateral non-comminuted zygomatic complex fracture undergo fixation of the complex by a customized plate at one point after 3D virtual simulation and reduction of the complex using Mimics software. Read more about this study
- Who is it for?
- Ages 15 to 65 years
- Conditions the study is for
- Zygomatic Fractures
- What is being tested?
- Titinium
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- No sites listed yet
- Study dates
- Mar 2018to Oct 2018
- 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 15 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients' age range from 15-65 years.
- Patients with unilateral zygomatic complex fracture
- Displaced fracture
- Dentulous or edentulous patients.
- Patients should be free from any systemic disease that may affect normal healing of bone and predictable outcome.
- Exclusion Criteria. Patients with systemic diseases as history of radiation therapy or chemotherapy, hematological disorders, neuromotor disorders and autoimmune diseases (may affect normal healing).
- Patients with comminuted fractures .
- Delayed presentation 3 weeks or more after the date of trauma.
Who cannot join
None listed.
About this study
Official title: Adequacy of One-Point Fixation of Displaced Zygomatic Complex Fractures Using a Customized Plate pre_post Study
Patients with unilateral non-comminuted zygomatic complex fracture undergo fixation of the complex by a customized plate at one point after 3D virtual simulation and reduction of the complex using Mimics software.
Read the detailed description
History data will be gathered including personal data, medical and surgical history, and family history.
Clinical examination and photographic records will be carried out to evaluate the magnitude and direction of the displaced zygoma, degree of facial asymmetry, neurosensory affection and functional disturbances.
Computed tomography (CT) scan:
Patients will receive a preoperative computed tomography (CT) scan of the facial bones [ Axial cuts, DICOM file, Gantry tilt zero and minimal thickness of 1 mm]. The radiographic data will be imported into a surgical simulation software to virtually reduce the fractured zygoma and custom design the plate for fixation.
General operative procedures:
- All cases will undergo surgery under general anesthesia with nasotracheal intubation.
- Intraoral maxillary vestibular approach will be used to gain access to the fractured zygomatic complex. Reduction of the fractured segment would be achieved using the appropriate techniques and instrumentation. One point ORIF would be accomplished using the customized plate.
- Conditions
- Zygomatic Fractures
- Being tested
- Titinium
- Medical subject headings
- Zygomatic Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TitiniumDevice
custom made plate at one point after 3D virtual simulation and reduction of the complex using Mimics software.
| Study group | Role | What they receive |
|---|---|---|
| Unilateral Non comminuted zygomatic complex fracture | Other | Patient undergo treatment no control group Receives: Device: Titinium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient satisfaction. Measuring device visual analogue scale. Measuring unit 0-10
Esthetics and function of patient return post operative. Normal
Measured: One week
Secondary outcomes (1)
Adequacy of reduction compared to the preoperative virtual simulation measuring device mimics software Ware. Measuring unit millimeters
Reduction of fracture on mimics soft ware depending on 3d virtual simulation and mirror image of the same patient and after operation I will compare post operative reduction to preoperative reduction on mimics soft ware in millimeters measuring unit
Measured: Immediately post operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2018
- Study startMar 2018 (estimated)
- Primary completionJul 2018 (estimated)
- Study completionOct 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Zygomatic 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
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Ashour Saad Borma, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03484676
- Sponsor's protocol ID
- CEBD-CU-2018-03-17
- Status last verified
- Mar 2018
- First submitted
- 13 Mar 2018
- Last updated
- 2 Apr 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adequacy of One-Point Fixation of Displaced Zygomatic Complex Fractures Using a Customized Plate pre_post Study
- ClinicalTrials.gov ID
- NCT03484676
- Acronym / sponsor ID
- CEBD-CU-2018-03-17
- Conditions
- Zygomatic Fractures
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Mar 2018 (estimated)
- Primary completion
- Jul 2018 (estimated)
- Study completion
- Oct 2018 (estimated)
- First posted
- 2 Apr 2018 (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 unilateral non-comminuted zygomatic complex fracture undergo fixation of the complex by a customized plate at one point after 3D virtual simulation and reduction of the complex using Mimics software.
Detailed description
History data will be gathered including personal data, medical and surgical history, and family history.
Clinical examination and photographic records will be carried out to evaluate the magnitude and direction of the displaced zygoma, degree of facial asymmetry, neurosensory affection and functional disturbances.
Computed tomography (CT) scan:
Patients will receive a preoperative computed tomography (CT) scan of the facial bones [ Axial cuts, DICOM file, Gantry tilt zero and minimal thickness of 1 mm]. The radiographic data will be imported into a surgical simulation software to virtually reduce the fractured zygoma and custom design the plate for fixation.
General operative procedures:
- All cases will undergo surgery under general anesthesia with nasotracheal intubation.
- Intraoral maxillary vestibular approach will be used to gain access to the fractured zygomatic complex. Reduction of the fractured segment would be achieved using the appropriate techniques and instrumentation. One point ORIF would be accomplished using the customized plate.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Unilateral Non comminuted zygomatic complex fracture | Other | Device: TitiniumPatient undergo treatment no control group |
Who may qualify
- Ages
- 15 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Patients' age range from 15-65 years.
- Patients with unilateral zygomatic complex fracture
- Displaced fracture
- Dentulous or edentulous patients.
- Patients should be free from any systemic disease that may affect normal healing of bone and predictable outcome.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Titiniumcustom made plate at one point after 3D virtual simulation and reduction of the complex using Mimics software. | Device | Unilateral Non comminuted zygomatic complex fracture |
Primary outcome
Patient satisfaction. Measuring device visual analogue scale. Measuring unit 0-10
Time frame: One week
Esthetics and function of patient return post operative. Normal
1 secondary outcome
Adequacy of reduction compared to the preoperative virtual simulation measuring device mimics software Ware. Measuring unit millimeters
Time frame: Immediately post operative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2018.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Titinium in people with Zygomatic Fractures, run by Cairo University.
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 8 inclusion and 0 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 2 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Patient satisfaction. Measuring device visual analogue scale. Measuring unit 0-10 (time frame: One week). 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 2 Apr 2018.