Zygomatic FracturesNCT07044258
Trans-tarsal Stair-step Lateral Extension of the Transconjunctival Approach
A study testing trans-tarsal stair-step lateral extension of the transconjunctival approach and transconjunctival approach in people with Zygomatic Fractures and Lower Eyelid Entropion, run by Alexandria University at 1 site in Egypt.
Trial summary
Open reduction and internal fixation of orbito-zygomaticomaxillary complex (OMC) fractures has challenging impact on the selection of suitable surgical approach to orbital and zygomatic skeleton. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Zygomatic Fractures, Lower Eyelid Entropion
- What is being tested?
- trans-tarsal stair-step lateral extension of the transconjunctival approach and transconjunctival approach
- 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
- 1 Oct 2024to 15 Jun 2025
- 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
- Patients with OMC fractures that require open reduction with internal fixation.
- Patients with orbital wall defects.
- Patients with blow out fractures.
- Adult patient between 18 and 60 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 or chronic conjunctival diseases.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Dentistry, Alexandria University
Alexandria, Alexandria Governorate, 21523
About this study
Official title: Trans-tarsal Stair-step Lateral Extension of the Transconjunctival Approach Versus Transconjunctival Approach in the Management of Orbito-zygomaticomaxillary Complex Fractures (Randomized Controlled Clinical Trial)
Open reduction and internal fixation of orbito-zygomaticomaxillary complex (OMC) fractures has challenging impact on the selection of suitable surgical approach to orbital and zygomatic skeleton. Precise repair of the OMC fractures needs a quite understanding of the regional anatomy, precise diagnosis, an accessible exposure and an accurate rigid fixation of fracture to restore the normal form. The esthetic results are one of the most important requirements for this incision in the facial fracture reduction. conventional approaches to the infraorbital rim/orbital floor include (subciliary mid lower eyelid, or subtarsal) and infraorbital incisions. A thorough understanding of each incisional technique requires an appreciation of the relevant anatomy putting in considerations the risk of associated complications. Transconjuctival incision has a lot of advantages, among which is the production of non-visible scar with low incidence of post -operative ectropion and limited access. Trans-tarsal stair-step lateral extension of the transconjunctival approach provides excellent surgical exposure of OMC fractures avoiding the use of a second incision in the area of zygomatic frontal suture. This technique provides good exposure and excellent esthetics.
the aim of this study is to compare Trans-tarsal Stair-Step Lateral Extension of the Transconjunctival approach with transconjunctival approach in the management of orbital and zygomaticomaxillary complex fractures.
Read the detailed description
This study will be made on twenty patients who will undergo fracture repair of the zygomaticomaxillary complex. Post- operative patient evaluation will be performed with specific attention paid towards accessibility, the exposure duration (time from incision till exposure of the field), esthetic appearance, post- operative pain, postoperative edema, orbital movement, wound healing, scarring, infra orbital nerve sensation and the post- operative ocular complications such as ectropion, entropion, enophthalmos, scleral show and corneal abrasion. Post- operative clinical examinations along with radiographic examination will be done to evaluate the position of zygoma and determine the adequacy of fracture reduction.
- Conditions
- Zygomatic Fractures, Lower Eyelid Entropion
- Being tested
- trans-tarsal stair-step lateral extension of the transconjunctival approach, transconjunctival approach
- Keywords
- Orbito-zygomaticomaxillary Fracture, Transconjunctival Incision, Lower eyelid
- Medical subject headings
- Zygomatic Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
trans-tarsal stair-step lateral extension of the transconjunctival approachProcedure or surgery
patients presented with oribto-zygomaticomaxillary complex fractures that requires open reduction and internal fixation via trans-tarsal stair-step lateral extension of the transconjunctival approach
transconjunctival approachProcedure or surgery
patients presented with oribto-zygomaticomaxillary complex fractures that requires open reduction and internal fixation via trans-tarsal stair-step lateral extension of the transconjunctival approach
| Study group | Role | What they receive |
|---|---|---|
| trans-tarsal stair-step lateral extension of the transconjunctival approach | Active comparator | patients presented with oribto-zygomaticomaxillary complex fractures that requires open reduction and internal fixation via trans-tarsal stair-step lateral extension of the transconjunctival approach Receives: Procedure: trans-tarsal stair-step lateral extension of the transconjunctival approach |
| transconjunctival approach | Experimental | patients presented with oribto-zygomaticomaxillary complex fractures that requires open reduction and internal fixation via transconjunctival approach Receives: Procedure: transconjunctival approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
exposure duration
The time taken between performing the incision till exposure of the field will be recorded using a stopwatch.
Measured: During the surgery
Secondary outcomes (1)
postoperative edema
The postoperative edema will be 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: 1.5 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2025
- Study start1 Oct 2024
- Primary completion30 Mar 2025
- Study completion15 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Zygomatic FracturesStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- patients presented with oribto-zygomaticomaxillary complex fractures that requires open reduction and internal fixation via trans-tarsal stair-step lateral extension of the transconjunctival approach
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07044258
- Sponsor's protocol ID
- Mod-Trans-2/25
- Status last verified
- Jun 2025
- First submitted
- 19 Jun 2025
- Last updated
- 29 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all data will be de-identified to protect the participant data. patients signed an informed consent for the use of their medical records and data for study
Publications
Sobhy DE, Dessoky NY, Alryess AM, Noureldin MG. Trans-tarsal stair-step versus transconjunctival approach in orbito-zygomaticomaxillary fractures: a prospective randomized controlled clinical trial. BMC Oral Health. 2026 Jun 17;26(1):1069. doi: 10.1186/s12903-026-08842-1.
PubMed 42304401
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trans-tarsal Stair-step Lateral Extension of the Transconjunctival Approach Versus Transconjunctival Approach in the Management of Orbito-zygomaticomaxillary Complex Fractures (Randomized Controlled Clinical Trial)
- ClinicalTrials.gov ID
- NCT07044258
- Acronym / sponsor ID
- Mod-Trans-2/25
- Conditions
- Zygomatic Fractures, Lower Eyelid Entropion
- Keywords
- Orbito-zygomaticomaxillary Fracture, Transconjunctival Incision, Lower eyelid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 30 Mar 2025 (actual)
- Study completion
- 15 Jun 2025 (actual)
- First posted
- 29 Jun 2025 (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.
Open reduction and internal fixation of orbito-zygomaticomaxillary complex (OMC) fractures has challenging impact on the selection of suitable surgical approach to orbital and zygomatic skeleton. Precise repair of the OMC fractures needs a quite understanding of the regional anatomy, precise diagnosis, an accessible exposure and an accurate rigid fixation of fracture to restore the normal form. The esthetic results are one of the most important requirements for this incision in the facial fracture reduction. conventional approaches to the infraorbital rim/orbital floor include (subciliary mid lower eyelid, or subtarsal) and infraorbital incisions. A thorough understanding of each incisional technique requires an appreciation of the relevant anatomy putting in considerations the risk of associated complications. Transconjuctival incision has a lot of advantages, among which is the production of non-visible scar with low incidence of post -operative ectropion and limited access. Trans-tarsal stair-step lateral extension of the transconjunctival approach provides excellent surgical exposure of OMC fractures avoiding the use of a second incision in the area of zygomatic frontal suture. This technique provides good exposure and excellent esthetics.
the aim of this study is to compare Trans-tarsal Stair-Step Lateral Extension of the Transconjunctival approach with transconjunctival approach in the management of orbital and zygomaticomaxillary complex fractures.
Detailed description
This study will be made on twenty patients who will undergo fracture repair of the zygomaticomaxillary complex. Post- operative patient evaluation will be performed with specific attention paid towards accessibility, the exposure duration (time from incision till exposure of the field), esthetic appearance, post- operative pain, postoperative edema, orbital movement, wound healing, scarring, infra orbital nerve sensation and the post- operative ocular complications such as ectropion, entropion, enophthalmos, scleral show and corneal abrasion. Post- operative clinical examinations along with radiographic examination will be done to evaluate the position of zygoma and determine the adequacy of fracture reduction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- patients presented with oribto-zygomaticomaxillary complex fractures that requires open reduction and internal fixation via trans-tarsal stair-step lateral extension of the transconjunctival approach
| Arm | Type | Receives |
|---|---|---|
| trans-tarsal stair-step lateral extension of the transconjunctival approach | Active comparator | Procedure: trans-tarsal stair-step lateral extension of the transconjunctival approachpatients presented with oribto-zygomaticomaxillary complex fractures that requires open reduction and internal fixation via trans-tarsal stair-step lateral extension of the transconjunctival approach |
| transconjunctival approach | Experimental | Procedure: transconjunctival approachpatients presented with oribto-zygomaticomaxillary complex fractures that requires open reduction and internal fixation via transconjunctival approach |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with OMC fractures that require open reduction with internal fixation.
- Patients with orbital wall defects.
- Patients with blow out fractures.
- Adult patient between 18 and 60 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 or 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 |
|---|---|---|
| trans-tarsal stair-step lateral extension of the transconjunctival approachpatients presented with oribto-zygomaticomaxillary complex fractures that requires open reduction and internal fixation via trans-tarsal stair-step lateral extension of the transconjunctival approach | Procedure or surgery | trans-tarsal stair-step lateral extension of the transconjunctival approach |
| transconjunctival approachpatients presented with oribto-zygomaticomaxillary complex fractures that requires open reduction and internal fixation via trans-tarsal stair-step lateral extension of the transconjunctival approach | Procedure or surgery | transconjunctival approach |
Primary outcome
exposure duration
Time frame: During the surgery
The time taken between performing the incision till exposure of the field will be recorded using a stopwatch.
1 secondary outcome
postoperative edema
Time frame: 1.5 month
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 29 Jun 2025.
- Derived from this study: PubMed 42304401Sobhy DE, Dessoky NY, Alryess AM, Noureldin MG. Trans-tarsal stair-step versus transconjunctival approach in orbito-zygomaticomaxillary fractures: a prospective randomized controlled clinical trial. BMC Oral Health. 2026 Jun 17;26(1):1069. doi: 10.1186/s12903-026-08842-1.
- Individual participant dataSharing planned: Yes. all data will be de-identified to protect the participant data. patients signed an informed consent for the use of their medical records and data for study
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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 trans-tarsal stair-step lateral extension of the transconjunctival approach and transconjunctival approach in people with Zygomatic Fractures and Lower Eyelid Entropion, 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 4 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 29 Jun 2025. 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?
exposure duration (time frame: During the surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07044258, which also lists 1 linked publication.
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 29 Jun 2025.