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

Primary Purpose

Zygomatic Fractures

Status

Completed

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

sideburns mini incision

coronal scalp incision

About this trial

This is an interventional treatment trial for Zygomatic Fractures focused on measuring Zygomatic Arch, Fracture Fixation

Eligibility Criteria

15 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Department of Oral and Maxillofacial Surgery, West China College of Stomatology, Sichuan University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

the sideburns mini incision group

the coronal scalp incision group

Arm Description

Forty patients (the sideburns mini incision group) were treated with sideburns mini incision.

Forty patients (the coronal scalp incision group) were treated with coronal scalp incision.

Outcomes

Primary Outcome Measures

Incision length

Incision length for open reduction and internal fixation of zygomatic arch fractures.

Operative duration

The length of time spent on operation.

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.

Postoperative stay

Days of postoperative hospital stay was calculated to evaluate patient recovery.

Postoperative adverse effects

Including bleeding, malocclusion, infection, nerve injury, etc.

Secondary Outcome Measures

Full Information

NCT ID

NCT05381337

First Posted

May 6, 2022

Last Updated

May 27, 2022

Sponsor

Wei Jing

1. Study Identification

Unique Protocol Identification Number

NCT05381337

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2022

Overall Recruitment Status

Completed

Study Start Date

January 1, 2021 (Actual)

Primary Completion Date

May 3, 2022 (Actual)

Study Completion Date

May 3, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Wei Jing

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Zygomatic Fractures

Keywords

Zygomatic Arch, Fracture Fixation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

80 (Actual)

8. Arms, Groups, and Interventions

Arm Title

the sideburns mini incision group

Arm Type

Experimental

Arm Description

Forty patients (the sideburns mini incision group) were treated with sideburns mini incision.

Arm Title

the coronal scalp incision group

Arm Type

Other

Arm Description

Forty patients (the coronal scalp incision group) were treated with coronal scalp incision.

Intervention Type

Procedure

Intervention Name(s)

sideburns mini incision

Intervention Description

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.

Intervention Type

Procedure

Intervention Name(s)

coronal scalp incision

Intervention Description

Coronal scalp incisions were used as control group.

Primary Outcome Measure Information:

Title

Incision length

Description

Incision length for open reduction and internal fixation of zygomatic arch fractures.

Time Frame

during the surgical procedure

Title

Operative duration

Description

The length of time spent on operation.

Time Frame

from the beginning to the end of surgery

Title

Postoperative pain

Description

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.

Time Frame

24 hours after surgery

Title

Postoperative stay

Description

Days of postoperative hospital stay was calculated to evaluate patient recovery.

Time Frame

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.

Title

Postoperative adverse effects

Description

Including bleeding, malocclusion, infection, nerve injury, etc.

Time Frame

from the end of surgery to 6 months after surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

15 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Wei Jing, Professor

Organizational Affiliation

Department of Oral and Maxillofacial Surgery, West China Hospital of Stomatology, Sichuan University

Official's Role

Study Chair

Facility Information:

Facility Name

Department of Oral and Maxillofacial Surgery, West China College of Stomatology, Sichuan University

City

Chengdu

State/Province

Sichuan

ZIP/Postal Code

610041

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

33038178

Citation

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Results Reference

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32606181

Citation

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Results Reference

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PubMed Identifier

32258152

Citation

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Results Reference

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PubMed Identifier

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Citation

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Results Reference

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Citation

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Results Reference

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Citation

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Citation

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Results Reference

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Citation

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Citation

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Citation

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Results Reference

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

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