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

Not Applicable

Completed

• Conditions: Zygomatic Fractures; Lower Eyelid Entropion

• Registration Number: NCT07044258
• Lead Sponsor: Alexandria University

Brief 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. 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 Timeline

• Study Start: 2024-10-01
• Primary Completion: 2025-03-30
• Status Verified: 2025-06
• Study Completion: 2025-06-15
• Study First Submitted: 2025-06-19
• Study First Submitted QC: 2025-06-27
• Last Update Submitted: 2025-06-27
• Study First Posted: 2025-06-29
• Last Update Posted: 2025-06-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
exposure duration	During the surgery	The time taken between performing the incision till exposure of the field will be recorded using a stopwatch.

Secondary Outcome Measures

Name	Time	Method
postoperative edema	1.5 month	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).

Trial Locations

Locations (1)

Faculty of Dentistry, Alexandria University; 🇪🇬 Alexandria, Egypt