Zygomatic FracturesNCT04836130
Evaluation of The Accuracy of Zygomatico- Maxillary Complex (ZMC) Fractures Reduction Using Patient Specific Guide (PSG) Versus Conventional Technique
A study testing patient specific guide and conventional technique in people with Zygomatic Fractures, run by Ahmed Morad.
Trial summary
Evaluation of The Accuracy of Zygomatico- Maxillary Complex (ZMC) Fractures reduction Using Patient Specific Guide (PSG) Versus Conventional Technique Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Zygomatic Fractures
- What is being tested?
- patient specific guide and conventional technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- No sites listed yet
- Study dates
- May 2021to Jun 2022
- 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
- • Zygomatic Fracture Type III, IV and V according to rowe and killey classification(13)
- Age (18-60 years)
- Recent fracture (less than 2 weeks)
Who cannot join
- • Zygomatic Fracture Type I, II and VI according to rowe and killey classification(13)
- Medical compromised patient
- Patient on radiotherapy
- Bone disease
About this study
Evaluation of The Accuracy of Zygomatico- Maxillary Complex (ZMC) Fractures reduction Using Patient Specific Guide (PSG) Versus Conventional Technique
- Conditions
- Zygomatic Fractures
- Being tested
- patient specific guide, conventional technique
- Medical subject headings
- Zygomatic Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
patient specific guideProcedure or surgery
patient specific guide reduction
conventional techniqueProcedure or surgery
conventional anatomical reduction
| Study group | Role | What they receive |
|---|---|---|
| (ZMC) Fractures reduction Using Patient Specific Guide (PSG) | Active comparator | Not described Receives: Procedure: patient specific guide |
| (ZMC) Fractures reduction Using Conventional Technique | Active comparator | Not described Receives: Procedure: conventional technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
accuracy of reduction of the fractured zygoma ( facial asymetry )
assessed by ct
Measured: up to 6 months
Secondary outcomes (1)
operation time
in hours
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2021
- Study startMay 2021 (estimated)
- Primary completionMay 2022 (estimated)
- Study completionJun 2022 (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.
- 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ahmed Morad
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ahmed Morad, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04836130
- Sponsor's protocol ID
- Omfs 3.3.10
- Status last verified
- Apr 2021
- First submitted
- 1 Apr 2021
- Last updated
- 8 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of The Accuracy of Zygomatico- Maxillary Complex (ZMC) Fractures Reduction Using Patient Specific Guide (PSG) Versus Conventional Technique
- ClinicalTrials.gov ID
- NCT04836130
- Acronym / sponsor ID
- Omfs 3.3.10
- Conditions
- Zygomatic Fractures
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Ahmed MoradUniversity, hospital or other
- Study start
- May 2021 (estimated)
- Primary completion
- May 2022 (estimated)
- Study completion
- Jun 2022 (estimated)
- First posted
- 8 Apr 2021 (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.
Evaluation of The Accuracy of Zygomatico- Maxillary Complex (ZMC) Fractures reduction Using Patient Specific Guide (PSG) Versus Conventional Technique
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| (ZMC) Fractures reduction Using Patient Specific Guide (PSG) | Active comparator | Procedure: patient specific guide |
| (ZMC) Fractures reduction Using Conventional Technique | Active comparator | Procedure: conventional technique |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- • Zygomatic Fracture Type III, IV and V according to rowe and killey classification(13)
Key exclusion criteria (4 listed)
- • Zygomatic Fracture Type I, II and VI according to rowe and killey classification(13)
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 |
|---|---|---|
| patient specific guidepatient specific guide reduction | Procedure or surgery | (ZMC) Fractures reduction Using Patient Specific Guide (PSG) |
| conventional techniqueconventional anatomical reduction | Procedure or surgery | (ZMC) Fractures reduction Using Conventional Technique |
Primary outcome
accuracy of reduction of the fractured zygoma ( facial asymetry )
Time frame: up to 6 months
assessed by ct
1 secondary outcome
operation time
Time frame: up to 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2021.
- Individual participant dataSharing planned: Undecided
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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 patient specific guide and conventional technique in people with Zygomatic Fractures, run by Ahmed Morad.
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 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 8 Apr 2021. 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?
accuracy of reduction of the fractured zygoma ( facial asymetry ) (time frame: up to 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 8 Apr 2021.