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

NCT07044258 | Completed

• 1 other identifier: Mod-Trans-2/25
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Zygomatic Fractures; Lower Eyelid Entropion

Keywords

Orbito-zygomaticomaxillary Fracture; Transconjunctival Incision; Lower eyelid

Outcome Measures

Primary Outcomes (1)

• exposure duration

  The time taken between performing the incision till exposure of the field will be recorded using a stopwatch.

  During the surgery

Secondary Outcomes (1)

• postoperative edema

  1.5 month

Study Arms (2)

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

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

Procedure: transconjunctival approach

Interventions

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

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

transconjunctival approach

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Faculty of Dentistry, Alexandria University

Alexandria, Alexandria Governorate, 21523, Egypt

Location

MeSH Terms

Conditions

Zygomatic Fractures

Condition Hierarchy (Ancestors)

Maxillofacial Injuries; Facial Injuries; Craniocerebral Trauma; Trauma, Nervous System; Nervous System Diseases; Skull Fractures; Fractures, Bone; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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 Record Dates

• First Submitted: June 19, 2025
• First Posted: June 29, 2025
• Study Start: October 1, 2024
• Primary Completion: March 30, 2025
• Study Completion: June 15, 2025
• Last Updated: June 29, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP
• Access Criteria: to any one who required them after deidentification

Locations

EG (1)