A Method of Calculating the Shortest Incision for Internal Fixation of Zygomatic Arch Fracture

Study Overview
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Brief Summary
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In this study, a new method was proposed to calculate the length of sideburns mini incision for zygomatic arch fracture. The purpose of this study was to compare the sideburns mini incision calculated by this method with the coronal scalp incision, so as to determine the therapeutic effect and advantages of sideburns mini incision calculated by this method.

Detailed Description
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Eighty patients with zygomatic arch fracture were treated with surgical intervention. Forty patients were treated with sideburns mini incision, and the other forty patients were treated with coronal scalp incision. Data such as incision length, operation time and postoperative complications were recorded. The follow-up periods were 6 months.

Official Title
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A Method of Calculating the Shortest Incision for Internal Fixation of Zygomatic Arch Fracture: Sideburns Mini Incision

Conditions
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Zygomatic Fractures

Intervention / Treatment
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* Procedure: sideburns mini incision
* Procedure: coronal scalp incision


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical and imaging diagnosis of zygomatic arch fracture or zygomatic maxillary complex fracture. Fracture fragments are obviously displaced, which affects the appearance and function of the patient. Simple prying is instable and requires open reduction and internal fixation. No previous surgical treatment. Exclusion Criteria: Accompanied by multiple fractures of mandible, nasal bone and so on. There are traumatic scars in the operation area, which can be accessed through the original wound. History of bone disease and / or wound healing disorders. Mental and intellectual disorders.

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 65 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 |
| --- | --- |
| Experimental: the sideburns mini incision group<br>Forty patients (the sideburns mini incision group) were treated with sideburns mini incision. | Procedure: sideburns mini incision<br>* The investigators present a new method to calculate the shortest incision for zygomatic fracture, and use this method to calculate the sideburns mini incision for the surgical treatment of zygomatic arch fracture.<br>|
| Other: the coronal scalp incision group<br>Forty patients (the coronal scalp incision group) were treated with coronal scalp incision. | Procedure: coronal scalp incision<br>* Coronal scalp incisions were used as control group.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incision length | Incision length for open reduction and internal fixation of zygomatic arch fractures. | during the surgical procedure | 
| Operative duration | The length of time spent on operation. | from the beginning to the end of surgery | 
| Postoperative pain | Visual Analogue Scale was used to evaluate the burden of postoperative pain. The maximum score is 10, and the minimum score is 0. Higher scores represent more intense pain. | 24 hours after surgery | 
| Postoperative stay | Days of postoperative hospital stay was calculated to evaluate patient recovery. | From the end of surgery until discharge, up to 15 days. After evaluation by the same chief knife physician, the patient recovered well postoperatively and could be discharged. | 
| Postoperative adverse effects | Including bleeding, malocclusion, infection, nerve injury, etc. | from the end of surgery to 6 months after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Zygomatic Arch, Fracture Fixation