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Trans-tarsal Stair-step Lateral Extension of the Transconjunctival Approach

NCT ID: NCT07044258

Last Updated: 2025-06-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-01

Study Completion Date

2025-06-15

Brief Summary

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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

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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

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Zygomatic Fractures Lower Eyelid Entropion

Keywords

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Orbito-zygomaticomaxillary Fracture Transconjunctival Incision Lower eyelid

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
Sequentially numbered, opaque, sealed envelopes (SNOSE) allocation concealment method will be utilized. Each participant included in the study will be given a serial number that will be used in the allocation. These numbers will be written in identical sheets of paper with the group to which each participant is allocated and placed inside opaque envelopes carrying the respective names of participants. A trial independent personnel will be assigned the role of keeping the envelopes and unfolding them only at the time of the operation, so that the participant is allocated to a group which is concealed from the operator

Study Groups

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trans-tarsal stair-step lateral extension of the transconjunctival approach

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

Group Type ACTIVE_COMPARATOR

trans-tarsal stair-step lateral extension of the transconjunctival approach

Intervention Type PROCEDURE

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 approach

patients presented with oribto-zygomaticomaxillary complex fractures that requires open reduction and internal fixation via transconjunctival approach

Group Type EXPERIMENTAL

transconjunctival approach

Intervention Type PROCEDURE

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

Interventions

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trans-tarsal stair-step lateral extension of the transconjunctival approach

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

Intervention Type PROCEDURE

transconjunctival approach

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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. Patients with OMC fractures that require open reduction with internal fixation.
2. Patients with orbital wall defects.
3. Patients with blow out fractures.
4. Adult patient between 18 and 60 years with no gender predilections.

Exclusion Criteria

1. Existing lacerations in the inferior and lateral periorbital regions.
2. Comminuted fracture with bone loss.
3. Existence of infection at the fracture line.
4. Presence of acute or chronic conjunctival diseases.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alexandria University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Faculty of Dentistry, Alexandria University

Alexandria, Alexandria Governorate, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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Mod-Trans-2/25

Identifier Type: -

Identifier Source: org_study_id