Y Transconjunctival Approach in Open Reduction of Zygomatic Maxillary Complex Fracture

NCT ID: NCT04719312

Last Updated: 2021-01-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-03
• Study Completion Date: 2020-10-07

Brief Summary

this study was made on fifteen patients who will undergo fracture repair of the zygomaticomaxillary complex.

Postoperative patient evaluation performed with specific attention paid towards, accessibility the exposure duration(time from incision till exposure of the field), esthetic appearance, post-operative pain, post-operative edema, orbital movement, wound healing, scarring infection, and the post-operative ocular complications such as ectropion, entropion, enophthalmos, scleral show and corneal abrasion.

Postoperative clinical examinations along with radiographic examination was done to evaluate the position of zygoma and determine the adequacy of fracture reduction.

Conditions

Zygomatic Fractures

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

transconjunctival Y modification

Group Type: EXPERIMENTAL

Y modification of transconjunctival approach

Intervention Type: PROCEDURE

Section of the orbital septum is done at the Arcus Marginalis and subperiosteal dissection done to expose the infraorbital rim and orbital floor.

Subsequently, canthotomy of the superficial limb of the lateral canthal ligament is performed and subperiosteal dissection is carried out to expose the fracture at the frontozygomatic region.

The cutaneous Y will transform into a box when retracting its corners, increasing the working area and allowing access of the frontozygomatic (FZ) suture, lateral orbital wall, body of the zygoma, infraorbital rim, and floor of the orbit with a single approach.

A small upper vestibular incision is placed to expose the fracture at the zygomatic buttress. Reduction and fixation of fractures in a regular fashion are accomplished.

Interventions

Y modification of transconjunctival approach

Section of the orbital septum is done at the Arcus Marginalis and subperiosteal dissection done to expose the infraorbital rim and orbital floor.

Subsequently, canthotomy of the superficial limb of the lateral canthal ligament is performed and subperiosteal dissection is carried out to expose the fracture at the frontozygomatic region.

The cutaneous Y will transform into a box when retracting its corners, increasing the working area and allowing access of the frontozygomatic (FZ) suture, lateral orbital wall, body of the zygoma, infraorbital rim, and floor of the orbit with a single approach.

A small upper vestibular incision is placed to expose the fracture at the zygomatic buttress. Reduction and fixation of fractures in a regular fashion are accomplished.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Patients with ZMC fractures that requires open reduction with internal fixation.
• Adult patient between 20 and 50 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 and chronic conjunctival diseases.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hams Hamed Abdelrahman

OTHER

Sponsor Role: lead

Responsible Party

Hams Hamed Abdelrahman

Assistant lecturer of DPH and Clinical statistician

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University, Egypt

Alexandria, Azarita, Egypt

Countries

Egypt

Other Identifiers

Y transconjunctival approach

Identifier Type: -

Identifier Source: org_study_id