Zygomatic FracturesNCT04719312
Y Transconjunctival Approach in Open Reduction of Zygomatic Maxillary Complex Fracture
A study testing Y modification of transconjunctival approach in people with Zygomatic Fractures, run by Hams Hamed Abdelrahman at 1 site in Egypt.
Trial summary
this study was made on fifteen patients who will undergo fracture repair of the zygomaticomaxillary complex. Postoperative patient evaluation performed with specific attention paid towards, accessibility the exposure duration(time from incision till exposure of the field), esthetic appearance, post-operative pain… Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Zygomatic Fractures
- What is being tested?
- Y modification of transconjunctival approach
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteEgypt
- Study dates
- 3 Mar 2019to 7 Oct 2020
- 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 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with ZMC fractures that requires open reduction with internal fixation.
- Adult patient between 20 and 50 years with no gender predilections.
Who cannot join
- Existing lacerations in the inferior and lateral periorbital regions.
- Comminuted fracture with bone loss.
- Existence of infection at the fracture line.
- Presence of Acute and chronic conjunctival diseases.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University, Egypt
Alexandria, Azarita, 00203
About this study
Official title: Evaluation of Modification of the Transconjunctival Approach in Open Reduction of Zygomatic Maxillary Complex Fracture
this study was made on fifteen patients who will undergo fracture repair of the zygomaticomaxillary complex.
Postoperative patient evaluation performed with specific attention paid towards, accessibility the exposure duration(time from incision till exposure of the field), esthetic appearance, post-operative pain, post-operative edema, orbital movement, wound healing, scarring infection, and the post-operative ocular complications such as ectropion, entropion, enophthalmos, scleral show and corneal abrasion.
Postoperative clinical examinations along with radiographic examination was done to evaluate the position of zygoma and determine the adequacy of fracture reduction.
- Conditions
- Zygomatic Fractures
- Being tested
- Y modification of transconjunctival approach
- Medical subject headings
- Zygomatic Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Y modification of transconjunctival approachProcedure or surgery
Section of the orbital septum is done at the Arcus Marginalis and subperiosteal dissection done to expose the infraorbital rim and orbital floor.
Subsequently, canthotomy of the superficial limb of the lateral canthal ligament is performed and subperiosteal dissection is carried out to expose the fracture at the frontozygomatic region.
The cutaneous Y will transform into a box when retracting its corners, increasing the working area and allowing access of the frontozygomatic (FZ) suture, lateral orbital wall, body of the zygoma, infraorbital rim, and floor of the orbit with a single approach.
A small upper vestibular incision is placed to expose the fracture at the zygomatic buttress. Reduction and fixation of fractures in a regular fashion are accomplished.
| Study group | Role | What they receive |
|---|---|---|
| transconjunctival Y modification | Experimental | Not described Receives: Procedure: Y modification of transconjunctival approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
The exposure duration
The time taken between performing the incision till exposure of the field
Measured: at the surgery
postoperative edema
the postoperative edema was categorized subjectively into mild (just noticeable), mild to moderate (more obvious edema without occlusion of palpebral fissure), moderate to severe (edema partially occluding palpebral fissure), and severe (edema totally occluding palpebral fissure).
Measured: after 1 week
change in postoperative pain
assessed through a 10-point Visual Analogue Scale (VAS),(34) (0-1=none,2-4=mild,5-7=moderate,8-10=severe).
Measured: 24 hours, 48 hours, 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study start3 Mar 2019
- Primary completion7 Oct 2020
- Study completion7 Oct 2020
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hams Hamed Abdelrahman
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hams Hamed Abdelrahman, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04719312
- Sponsor's protocol ID
- Y transconjunctival approach
- Status last verified
- Jan 2021
- First submitted
- 17 Jan 2021
- Last updated
- 22 Jan 2021
- 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 22 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Modification of the Transconjunctival Approach in Open Reduction of Zygomatic Maxillary Complex Fracture
- ClinicalTrials.gov ID
- NCT04719312
- Acronym / sponsor ID
- Y transconjunctival approach
- Conditions
- Zygomatic Fractures
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Hams Hamed AbdelrahmanUniversity, hospital or other
- Study start
- 3 Mar 2019 (actual)
- Primary completion
- 7 Oct 2020 (actual)
- Study completion
- 7 Oct 2020 (actual)
- First posted
- 22 Jan 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.
this study was made on fifteen patients who will undergo fracture repair of the zygomaticomaxillary complex.
Postoperative patient evaluation performed with specific attention paid towards, accessibility the exposure duration(time from incision till exposure of the field), esthetic appearance, post-operative pain, post-operative edema, orbital movement, wound healing, scarring infection, and the post-operative ocular complications such as ectropion, entropion, enophthalmos, scleral show and corneal abrasion.
Postoperative clinical examinations along with radiographic examination was done to evaluate the position of zygoma and determine the adequacy of fracture reduction.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| transconjunctival Y modification | Experimental | Procedure: Y modification of transconjunctival approach |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patients with ZMC fractures that requires open reduction with internal fixation.
- Adult patient between 20 and 50 years with no gender predilections.
Key exclusion criteria (4 listed)
- Existing lacerations in the inferior and lateral periorbital regions.
- Comminuted fracture with bone loss.
- Existence of infection at the fracture line.
- Presence of Acute and chronic conjunctival diseases.
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 |
|---|---|---|
| Y modification of transconjunctival approachSection of the orbital septum is done at the Arcus Marginalis and subperiosteal dissection done to expose the infraorbital rim and orbital floor. Subsequently, canthotomy of the superficial limb of the lateral canthal ligament is performed and subperiosteal dissection is carried out to expose the fracture at the frontozygomatic region. The cutaneous Y will transform into a box when retracting its corners, increasing the working area and allowing access of the frontozygomatic (FZ) suture, lateral orbital wall, body of the zygoma, infraorbital rim, and floor of the orbit with a single approach. A small upper vestibular incision is placed to expose the fracture at the zygomatic buttress. Reduction and fixation of fractures in a regular fashion are accomplished. | Procedure or surgery | transconjunctival Y modification |
Primary outcome
The exposure duration
Time frame: at the surgery
The time taken between performing the incision till exposure of the field
postoperative edema
Time frame: after 1 week
the postoperative edema was categorized subjectively into mild (just noticeable), mild to moderate (more obvious edema without occlusion of palpebral fissure), moderate to severe (edema partially occluding palpebral fissure), and severe (edema totally occluding palpebral fissure).
change in postoperative pain
Time frame: 24 hours, 48 hours, 1 week
assessed through a 10-point Visual Analogue Scale (VAS),(34) (0-1=none,2-4=mild,5-7=moderate,8-10=severe).
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 22 Jan 2021.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Y modification of transconjunctival approach in people with Zygomatic Fractures, run by Hams Hamed Abdelrahman 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 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: finished, as of the sponsor's last update on 22 Jan 2021. 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?
The exposure duration (time frame: at the surgery). The study lists 3 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 22 Jan 2021.