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NCT Number: NCT07044258

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

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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Key information

Conditions

Zygomatic Fractures Craniocerebral Trauma Facial Injuries Fractures, Bone Lower Eyelid Entropion Maxillofacial Injuries Nervous System Diseases Skull Fractures Trauma, Nervous System Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry, Alexandria University

Alexandria, Alexandria Governorate, 21523, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. postoperative edema

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Official study 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)

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jun 29, 2025
Registry last updated
Jun 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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