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

NCT05381337 | Completed

• 1 other identifier: WCHSIRB-D-2021-264
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Zygomatic Fractures

Keywords

Zygomatic Arch; Fracture Fixation

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (2)

the sideburns mini incision group

EXPERIMENTAL

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

Procedure: sideburns mini incision

the coronal scalp incision group

OTHER

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

Procedure: coronal scalp incision

Interventions

sideburns mini incision PROCEDURE

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.

the sideburns mini incision group

coronal scalp incision PROCEDURE

Coronal scalp incisions were used as control group.

the coronal scalp incision group

Eligibility Criteria

• Age: 15 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wei Jing: lead

Study Sites (1)

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

Chengdu, Sichuan, 610041, China

Location

Related Publications (12)

• Huang L, Jiang C, Lin Y, Wen Y, Huang X, Huang J, Lin L. Analysis of Maxillofacial Fractures Based on the Etiology in Southeast China: A 10-Year, Multi-Center Study. J Craniofac Surg. 2021 Jun 1;32(4):1432-1435. doi: 10.1097/SCS.0000000000007183.

  PMID: 33038178 RESULT

• Tent PA, Juncar RI, Juncar M. Epidemiological Analysis of Zygomatic Bone Fractures in North-Western Romanian Population: A 10-Year Retrospective Study. In Vivo. 2020 Jul-Aug;34(4):2049-2055. doi: 10.21873/invivo.12006.

  PMID: 32606181 RESULT

• Kim JH, Kim YS, Oh DY, Jun YJ, Rhie JW, Moon SH. Efficacy of Altered Two-Point Fixation in Zygomaticomaxillary Complex Fracture. Biomed Res Int. 2020 Mar 18;2020:8537345. doi: 10.1155/2020/8537345. eCollection 2020.

  PMID: 32258152 RESULT

• Panneerselvam E, Balasubramanian S, Kempraj J, Babu VR, Raja VBKK. Management of Zygomatic Arch Fractures by Intraoral Open Reduction and Transbuccal Fixation: A Technical Note. Craniomaxillofac Trauma Reconstr. 2020 Jun;13(2):130-132. doi: 10.1177/1943387520911866. Epub 2020 Mar 17.

  PMID: 32642044 RESULT

• Cheon JS, Seo BN, Yang JY, Son KM. Clinical Follow-up on Sagittal Fracture at the Temporal Root of the Zygomatic Arch: Does It Need Open Reduction? Arch Plast Surg. 2013 Sep;40(5):546-52. doi: 10.5999/aps.2013.40.5.546. Epub 2013 Sep 13.

  PMID: 24086808 RESULT

• Birgfeld CB, Mundinger GS, Gruss JS. Evidence-Based Medicine: Evaluation and Treatment of Zygoma Fractures. Plast Reconstr Surg. 2017 Jan;139(1):168e-180e. doi: 10.1097/PRS.0000000000002852.

  PMID: 28027253 RESULT

• Strong EB, Gary C. Management of Zygomaticomaxillary Complex Fractures. Facial Plast Surg Clin North Am. 2017 Nov;25(4):547-562. doi: 10.1016/j.fsc.2017.06.006.

  PMID: 28941507 RESULT

• Ling XF, Yew CC, Mohd Nazri SB, Tew MM. Unilateral Zygomatic Complex Fracture - A Comparison Between Nonsurgical Treatment and Surgical Treatment. J Craniofac Surg. 2021 Oct 1;32(7):e627-e630. doi: 10.1097/SCS.0000000000007603.

  PMID: 33654041 RESULT

• Sanada Y, Yabuuchi T, Yoshioka H, Kubota H, Kato A. Zigzag skin incision effectively camouflages the scar and alopecia for moyamoya disease: technical note. Neurol Med Chir (Tokyo). 2015;55(3):210-3. doi: 10.2176/nmc.tn.2014-0193. Epub 2015 Feb 20.

  PMID: 25739436 RESULT

• Ji SY, Kim SS, Kim MH, Yang WS. Surgical Methods of Zygomaticomaxillary Complex Fracture. Arch Craniofac Surg. 2016 Dec;17(4):206-210. doi: 10.7181/acfs.2016.17.4.206. Epub 2016 Dec 23.

  PMID: 28913285 RESULT

• Verpaele A, Tonnard P, Gaia S, Guerao FP, Pirayesh A. The third suture in MACS-lifting: making midface-lifting simple and safe. J Plast Reconstr Aesthet Surg. 2007;60(12):1287-95. doi: 10.1016/j.bjps.2006.12.012. Epub 2007 Jun 29.

  PMID: 17604708 RESULT

• Chopan M, Buchanan PJ, Mast BA. The Minimal Access Cranial Suspension Lift. Clin Plast Surg. 2019 Oct;46(4):547-557. doi: 10.1016/j.cps.2019.06.005. Epub 2019 Aug 2.

  PMID: 31514807 RESULT

MeSH Terms

Conditions

Zygomatic Fractures

Condition Hierarchy (Ancestors)

Maxillofacial Injuries; Facial Injuries; Craniocerebral Trauma; Trauma, Nervous System; Nervous System Diseases; Skull Fractures; Fractures, Bone; Wounds and Injuries

Study Officials

• Wei Jing, Professor

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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 6, 2022
• First Posted: May 19, 2022
• Study Start: January 1, 2021
• Primary Completion: May 3, 2022
• Study Completion: May 3, 2022
• Last Updated: June 1, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)