Y Transconjunctival Approach in Open Reduction of Zygomatic Maxillary Complex Fracture

Zygomatic Fractures Clinical Trial

Official title:

Evaluation of Modification of the Transconjunctival Approach in Open Reduction of Zygomatic Maxillary Complex Fracture

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04719312
• Other study ID #: Y transconjunctival approach
• Status: Completed
• Phase: N/A
• Start date: March 3, 2019
• Est. completion date: October 7, 2020

Study information

• Verified date: January 2021
• Source: Alexandria University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: October 7, 2020
• Est. primary completion date: October 7, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fractures, Bone
• Zygomatic Fractures

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
Egypt	Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University, Egypt	Alexandria	Azarita

Sponsors (1)

Lead Sponsor	Collaborator
Hams Hamed Abdelrahman

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The exposure duration	The time taken between performing the incision till exposure of the field	at the surgery
Primary	postoperative edema	the postoperative edema was 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).	after 1 week
Primary	change in postoperative pain	assessed through a 10-point Visual Analogue Scale (VAS),(34) (0-1=none,2-4=mild,5-7=moderate,8-10=severe).	24 hours, 48 hours, 1 week