Zygomatic Arch ReductionPhase 1/2NCT04218058
Reduction of Zygomatic Arch in Zygomaticomaxillary Fractures
A Phase 1/2 study testing reduction of zygomatic arch in zygomaticomaxillary complex fracture in people with Zygomatic Arch Reduction, run by Alexandria University at 1 site in Egypt.
Trial summary
To compare between ultrasound guided closed reduction and open reduction of zygomatic arch in cases of zygomaticomaxillary fracture. To evaluate the role of intra-operative ultrasound during zygomatic arch reduction. Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Zygomatic Arch Reduction
- What is being tested?
- reduction of zygomatic arch in zygomaticomaxillary complex fracture
- 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
- 15 May 2018to 23 Nov 2019
- Phase
- Phase 1/2
- 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 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients presenting with ZMC fractures that require reduction and fixation
- Patients between 20 to 50 years old with no gender predilections
Who cannot join
- Existence of infection at the fracture line
- Chronic systemic diseases such as metabolic bone disease, immunocompromised status
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasound Guided Closed Reduction Versus Open Reduction of Zygomatic Arch in Zygomaticomaxillary Fractures
To compare between ultrasound guided closed reduction and open reduction of zygomatic arch in cases of zygomaticomaxillary fracture.
To evaluate the role of intra-operative ultrasound during zygomatic arch reduction.
To compare between esthetic appearance, orbital movement, wound healing, scaring, and postoperative ocular complications in both groups.
- Conditions
- Zygomatic Arch Reduction
- Being tested
- reduction of zygomatic arch in zygomaticomaxillary complex fracture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
reduction of zygomatic arch in zygomaticomaxillary complex fractureProcedure or surgery
Also called open reduction of zygomatic arch in zygomaticomaxillary complex fracture
ultrasound guided reduction of zygomatic arch
| Study group | Role | What they receive |
|---|---|---|
| study (ultrasound guided closed reduction of zygomatic arch)) | Active comparator | reduction of zygomatic arch guided by ultrasound Receives: Procedure: reduction of zygomatic arch in zygomaticomaxillary complex fracture |
| control (open reduction of zygomatic arch) | Active comparator | open reduction of zygomatic arch through coronal incision Receives: Procedure: reduction of zygomatic arch in zygomaticomaxillary complex fracture |
What is being measured
The primary outcome is the main question the study is designed to answer.
zygomatic arch reduction
to measure the amount of zygomatic arch reduction on postoperative ct scan and compare it with the normal side
Measured: immediate post operative CT scan
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2020
- Study start15 May 2018
- Primary completion25 Sep 2019
- Study completion23 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Zygomatic Arch ReductionStudies of the same condition, open and under way.
- More trials run by Alexandria 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tasneem Ahmed Mabrouk Amer, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04218058
- Sponsor's protocol ID
- 0020
- Status last verified
- Jan 2020
- First submitted
- 30 Dec 2019
- Last updated
- 6 Jan 2020
- 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 6 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Guided Closed Reduction Versus Open Reduction of Zygomatic Arch in Zygomaticomaxillary Fractures
- ClinicalTrials.gov ID
- NCT04218058
- Acronym / sponsor ID
- 0020
- Conditions
- Zygomatic Arch Reduction
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 15 May 2018 (actual)
- Primary completion
- 25 Sep 2019 (actual)
- Study completion
- 23 Nov 2019 (actual)
- First posted
- 6 Jan 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.
To compare between ultrasound guided closed reduction and open reduction of zygomatic arch in cases of zygomaticomaxillary fracture.
To evaluate the role of intra-operative ultrasound during zygomatic arch reduction.
To compare between esthetic appearance, orbital movement, wound healing, scaring, and postoperative ocular complications in both groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study (ultrasound guided closed reduction of zygomatic arch)) | Active comparator | Procedure: reduction of zygomatic arch in zygomaticomaxillary complex fracturereduction of zygomatic arch guided by ultrasound |
| control (open reduction of zygomatic arch) | Active comparator | Procedure: reduction of zygomatic arch in zygomaticomaxillary complex fractureopen reduction of zygomatic arch through coronal incision |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patients presenting with ZMC fractures that require reduction and fixation
- Patients between 20 to 50 years old with no gender predilections
Key exclusion criteria (2 listed)
- Existence of infection at the fracture line
- Chronic systemic diseases such as metabolic bone disease, immunocompromised status
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 |
|---|---|---|
| reduction of zygomatic arch in zygomaticomaxillary complex fractureAlso: open reduction of zygomatic arch in zygomaticomaxillary complex fractureultrasound guided reduction of zygomatic arch | Procedure or surgery | control (open reduction of zygomatic arch), study (ultrasound guided closed reduction of zygomatic arch)) |
Primary outcome
zygomatic arch reduction
Time frame: immediate post operative CT scan
to measure the amount of zygomatic arch reduction on postoperative ct scan and compare it with the normal side
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 6 Jan 2020.
- Individual participant dataSharing planned: Undecided
Related trials for Zygomatic Arch Reduction
Enrolling by invitation
Accuracy of Positioning Guide and Customized Plate in Zygomaticomaxillary Complex Fracture
Zygomaticomaxillary Complex Fracture, Zygoma Fracture
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing reduction of zygomatic arch in zygomaticomaxillary complex fracture in people with Zygomatic Arch Reduction, run by Alexandria 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 2 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 6 Jan 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
zygomatic arch reduction (time frame: immediate post operative CT scan). 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 6 Jan 2020.