A Comparison of Three Surgical Approaches to Zygomaticomaxillary Fractures

The Best Approach to Zygomaticomaxillary Fractures: A Comparison of Three Surgical Approaches

The study is a randomized controlled clinical trial, following the Consolidated Standards of Reporting Trials (CONSORT) guidelines. The study is intended to compare between the subtarsal approach, conventional transconjuctival approach and the Y- modification of the transconjuctival approach in the management of zygomatico-maxillay complex fracture.

Study Overview

• Status: Completed
• Conditions: Zygomatic Fractures
• Intervention / Treatment: Procedure: subtarsal approach; Procedure: conventional transconjunctival approach; Procedure: transconjunctival approach with Y- modification

Detailed Description

The study is a randomized controlled clinical trial. Twenty-four patients with age range of 20-50 years requiring open reduction and fixation of a fractured zygomatic complex were randomly divided into three equal groups according to the approach used:

Group A: subtarsal approach group. Group B: conventional transconjuctival approach group. Group C: Y- modification of the transconjuctival approach group.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Alexandria, Egypt, 21526
    • Faculty of Dentistry, Alexandria University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 50 years (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients with ZMC fractures requiring open reduction and internal fixation.
• Adult patients aged between 20 and 50 years with no gender predilection.

Exclusion Criteria:

• An existing laceration in the inferior and lateral periorbital site.
• Infection at the fracture line.
• Comminuted fracture with bone loss.
• Acute and chronic conjunctival diseases.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: subtarsal approach	Procedure: subtarsal approach; surgical approach
Active Comparator: conventional transconjunctival approach	Procedure: conventional transconjunctival approach; surgical approach
Active Comparator: transconjunctival approach with Y- modification	Procedure: transconjunctival approach with Y- modification; surgical approach

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
accessibility to the fracture site	Adequate exposure provided by the incision and accessiblity to proper fracture reduction and fixation was assigned as Yes or No	intraoperative
esthetic appearance and scarring	Postoperative scarring was recorded as noticeable or unnoticeable	6 weeks postoperative
radiographic verification of adequacy of fracture reduction	computed tomography was requested for adequacy of fracture reduction assessment and this outcome was assigned as Yes or No	immediate postoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The duration for exposure of the fracture site	The duration from performing the incision till the field exposure calculated in minutes	intraoperative
postoperative pain	Pain was evaluated at 24 hours and at 1 week according to a 10-point Visual Analogue Scale (VAS), (0-1=none,2-4=mild,5-7=moderate,8-10=severe).	at 24 hours and 1 week
sensory nerve function	Subjective assessment of the infraorbital nerve sensation by patient questioning about any alteration in sensation at 3 months postoperatively. Objective assessment by dental probe pressure to assess sensory changes along the distribution of the infraorbital nerve with contralateral side comparison	3 months postoperative

Collaborators and Investigators

• Sponsor: University of Alexandria

Study record dates

Study Major Dates

• Study Start (Actual): August 26, 2022
• Primary Completion (Actual): February 1, 2023
• Study Completion (Actual): February 5, 2023

Study Registration Dates

• First Submitted: January 11, 2023
• First Submitted That Met QC Criteria: January 13, 2023
• First Posted (Actual): January 25, 2023

Study Record Updates

• Last Update Posted (Actual): May 9, 2023
• Last Update Submitted That Met QC Criteria: May 8, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Maxillofacial Injuries; Facial Injuries; Skull Fractures; Fractures, Bone; Zygomatic Fractures
• Other Study ID Numbers: UAlexandriaMaxFacSurg

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No