A Comparison of Three Surgical Approaches to Zygomaticomaxillary Fractures

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Zygomatic Fractures

Intervention / Treatment
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* Procedure: subtarsal approach
* Procedure: conventional transconjunctival approach
* Procedure: transconjunctival approach with Y- modification


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: subtarsal approach<br> | Procedure: subtarsal approach<br>* surgical approach<br>|
| Active Comparator: conventional transconjunctival approach<br> | Procedure: conventional transconjunctival approach<br>* surgical approach<br>|
| Active Comparator: transconjunctival approach with Y- modification<br> | Procedure: transconjunctival approach with Y- modification<br>* surgical approach<br>|

What is the study measuring?
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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 |