Assessment of Proper Union of FracturesNCT04214405
One Point Versus Two Point Fixation of Tripodal Zygomatic Fractures
A study testing fixation of tripodal zygomatic fractures in people with Assessment of Proper Union of Fractures, run by Mohamed Gamal Thabet at 1 site in Egypt.
Trial summary
The zygomatic bone defines the anterior and lateral projection of the face and articulates with the frontal, sphenoid,temporal, and maxillary bones. The zygomatic complex is responsible for the protection of the orbital contents and the mid-facial contour. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Assessment of Proper Union of Fractures
- What is being tested?
- fixation of tripodal zygomatic fractures
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2020to 4 Aug 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (a) Adult patients with maxillofacial fractures including tripodal zygomatic fractures as determined on clinical and radiological finding (b) Isolated tripodal fracture zygoma
Who cannot join
- patients with Le Fort I/II/III fractures
Trial locations and contacts
1 site in 1 country.
About this study
The zygomatic bone defines the anterior and lateral projection of the face and articulates with the frontal, sphenoid,temporal, and maxillary bones. The zygomatic complex is responsible for the protection of the orbital contents and the mid-facial contour. Fracture of the zygomatic complex is one of the most common facial injuries in maxillofacial trauma and predominately appears in young adult males. The etiology of zygomatic complex fractures primarily includes road traffic accidents, violent assaults, falls and sports injuries. The main clinical features of zygomatic complex fractures include diplopia, enophthalmos, subconjunctival ecchymosis, extraocular muscle entrapment, cosmetic deformity with depression of the malar eminence, malocclusion and neurosensory disturbances of the infraorbital nerve. Diagnosis of zygomatic complex fractures is usually clinical with confirmation by computed tomography (CT) scan. Zygomatic complex fractures with no or minimal displacement are often treated without surgical intervention, whereas fractures with functional or esthetic impairments often necessitate surgical intervention. Various surgical approaches and treatment strategies have been proposed to obtain successful treatment outcome, including the Gilles temporal approach, eyebrow, upper eyelid, transconjunctival, infraciliary lower eyelid, and intraoral vestibular approaches. The surgical approach for adequate reduction of zygomatic complex fractures must ensure a good functional and cosmetic result. Surgical reduction of zygomatic fractures by an intraoral surgical approach was first described in1909 by Keen, and several studies have subsequently documented the treatment outcome after open reduction of zygomatic complex fractures by an intraoral surgical approach.
Read the detailed description
This study is a prospective clinical intervention study where the admitted patients do lab investigation as CBC, coagulation profile ,Kidney function test and Imaging as CT maxillofacial with axial and coronal cuts. Patients will be assigned randomly into either one of the two groups under the study using concealed envelope. Under general anaesthesia with oral or naso-tracheal intubation, open reduction and internal fixation of tripod zygomatic fractures will be done using miniplates and screws at one point (zygomaticomaxillary area) or at two points (zygomaticomaxillary and frontozygomatic areas).
- Conditions
- Assessment of Proper Union of Fractures
- Being tested
- fixation of tripodal zygomatic fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fixation of tripodal zygomatic fracturesProcedure or surgery
One point versus two point fixation of tripodal zygomatic fractures
| Study group | Role | What they receive |
|---|---|---|
| union of fractures | Experimental | proper union of zygomatic fractures Receives: Procedure: fixation of tripodal zygomatic fractures |
What is being measured
The primary outcome is the main question the study is designed to answer.
union of fractures
assessment of proper union of fractures
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2020
- Study start1 Feb 2020
- Primary completion1 Jul 2021
- Study completion4 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Assessment of Proper Union of 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mohamed Gamal Thabet
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mohamed Gamal Thabet, Assiut University
- Investigators
- Mohamed Gamal, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04214405
- Sponsor's protocol ID
- Mohamed Gamal Thabet
- Status last verified
- May 2022
- First submitted
- 28 Dec 2019
- Last updated
- 20 May 2022
- 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 20 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- One Point Versus Two Point Fixation of Tripodal Zygomatic Fractures
- ClinicalTrials.gov ID
- NCT04214405
- Acronym / sponsor ID
- Mohamed Gamal Thabet
- Conditions
- Assessment of Proper Union of Fractures
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Mohamed Gamal ThabetUniversity, hospital or other
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 4 Aug 2021 (actual)
- First posted
- 2 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.
The zygomatic bone defines the anterior and lateral projection of the face and articulates with the frontal, sphenoid,temporal, and maxillary bones. The zygomatic complex is responsible for the protection of the orbital contents and the mid-facial contour. Fracture of the zygomatic complex is one of the most common facial injuries in maxillofacial trauma and predominately appears in young adult males. The etiology of zygomatic complex fractures primarily includes road traffic accidents, violent assaults, falls and sports injuries. The main clinical features of zygomatic complex fractures include diplopia, enophthalmos, subconjunctival ecchymosis, extraocular muscle entrapment, cosmetic deformity with depression of the malar eminence, malocclusion and neurosensory disturbances of the infraorbital nerve. Diagnosis of zygomatic complex fractures is usually clinical with confirmation by computed tomography (CT) scan. Zygomatic complex fractures with no or minimal displacement are often treated without surgical intervention, whereas fractures with functional or esthetic impairments often necessitate surgical intervention. Various surgical approaches and treatment strategies have been proposed to obtain successful treatment outcome, including the Gilles temporal approach, eyebrow, upper eyelid, transconjunctival, infraciliary lower eyelid, and intraoral vestibular approaches. The surgical approach for adequate reduction of zygomatic complex fractures must ensure a good functional and cosmetic result. Surgical reduction of zygomatic fractures by an intraoral surgical approach was first described in1909 by Keen, and several studies have subsequently documented the treatment outcome after open reduction of zygomatic complex fractures by an intraoral surgical approach.
Detailed description
This study is a prospective clinical intervention study where the admitted patients do lab investigation as CBC, coagulation profile ,Kidney function test and Imaging as CT maxillofacial with axial and coronal cuts. Patients will be assigned randomly into either one of the two groups under the study using concealed envelope. Under general anaesthesia with oral or naso-tracheal intubation, open reduction and internal fixation of tripod zygomatic fractures will be done using miniplates and screws at one point (zygomaticomaxillary area) or at two points (zygomaticomaxillary and frontozygomatic areas).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| union of fractures | Experimental | Procedure: fixation of tripodal zygomatic fracturesproper union of zygomatic fractures |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- (a) Adult patients with maxillofacial fractures including tripodal zygomatic fractures as determined on clinical and radiological finding (b) Isolated tripodal fracture zygoma
Key exclusion criteria (1 listed)
- patients with Le Fort I/II/III fractures
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 |
|---|---|---|
| fixation of tripodal zygomatic fracturesOne point versus two point fixation of tripodal zygomatic fractures | Procedure or surgery | union of fractures |
Primary outcome
union of fractures
Time frame: 2 months
assessment of proper union of fractures
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 20 May 2022.
- 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.
Mohamed Gamal principal investigator
Assiut 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 fixation of tripodal zygomatic fractures in people with Assessment of Proper Union of Fractures, run by Mohamed Gamal Thabet 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 1 inclusion and 1 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 20 May 2022. 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?
union of fractures (time frame: 2 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 20 May 2022.