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

NCT07044258 — Not applicable, Completed, 20 participants, Alexandria University

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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)

Registry	NCT07044258
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: single, treatment
Enrollment	20 (Actual)
Sponsor	Alexandria University (Other)
Conditions	Zygomatic Fractures, Lower Eyelid Entropion
Interventions	trans-tarsal stair-step lateral extension of the transconjunctival approach, transconjunctival approach (Procedure)
Dates	start 2024-10-01, primary completion 2025-03-30, completion 2025-06-15, first posted 2025-06-29, last updated 2025-06-29
Locations	1 site in Egypt

-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.

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
trans-tarsal stair-step lateral extension of the transconjunctival approach	Active comparator	Procedure: 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
transconjunctival approach	Experimental	Procedure: transconjunctival approach	patients presented with oribto-zygomaticomaxillary complex fractures that requires open reduction and internal fixation via transconjunctival approach

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

+Outcome measures

Primary outcomes

exposure duration [During the surgery]: The time taken between performing the incision till exposure of the field will be recorded using a stopwatch.

Secondary outcomes

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).

+Eligibility

Sex: All, ages: 18 Years to any

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.

+Locations (1)

Facility	City	Country	Status
Faculty of Dentistry, Alexandria University	Alexandria, Alexandria Governorate	Egypt

+Publications

Results publication: 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. PMID 42304401

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