One Point Versus Two Point Fixation of Tripodal Zygomatic Fractures

The zygomatic bone defines the anterior and lateral projection of the face and articulates with the frontal, sphenoid,temporal, and maxillary bones. The zygomatic complex is responsible for the protection of the orbital contents and the mid-facial contour. Fracture of the zygomatic complex is one of the most common facial injuries in maxillofacial trauma and predominately appears in young adult males. The etiology of zygomatic complex fractures primarily includes road traffic accidents, violent assaults, falls and sports injuries. The main clinical features of zygomatic complex fractures include diplopia, enophthalmos, subconjunctival ecchymosis, extraocular muscle entrapment, cosmetic deformity with depression of the malar eminence, malocclusion and neurosensory disturbances of the infraorbital nerve. Diagnosis of zygomatic complex fractures is usually clinical with confirmation by computed tomography (CT) scan. Zygomatic complex fractures with no or minimal displacement are often treated without surgical intervention, whereas fractures with functional or esthetic impairments often necessitate surgical intervention. Various surgical approaches and treatment strategies have been proposed to obtain successful treatment outcome, including the Gilles temporal approach, eyebrow, upper eyelid, transconjunctival, infraciliary lower eyelid, and intraoral vestibular approaches. The surgical approach for adequate reduction of zygomatic complex fractures must ensure a good functional and cosmetic result. Surgical reduction of zygomatic fractures by an intraoral surgical approach was first described in1909 by Keen, and several studies have subsequently documented the treatment outcome after open reduction of zygomatic complex fractures by an intraoral surgical approach.

Study Overview

• Status: Completed
• Conditions: Assessment of Proper Union of Fractures
• Intervention / Treatment: Procedure: fixation of tripodal zygomatic fractures

Detailed Description

This study is a prospective clinical intervention study where the admitted patients do lab investigation as CBC, coagulation profile ,Kidney function test and Imaging as CT maxillofacial with axial and coronal cuts. Patients will be assigned randomly into either one of the two groups under the study using concealed envelope. Under general anaesthesia with oral or naso-tracheal intubation, open reduction and internal fixation of tripod zygomatic fractures will be done using miniplates and screws at one point (zygomaticomaxillary area) or at two points (zygomaticomaxillary and frontozygomatic areas).

• Study Type: Interventional
• Enrollment (Actual): 68
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Assiut, Egypt, 71111
    • AssiutU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• (a) Adult patients with maxillofacial fractures including tripodal zygomatic fractures as determined on clinical and radiological finding (b) Isolated tripodal fracture zygoma

Exclusion Criteria:

• patients with Le Fort I/II/III fractures

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: union of fractures; proper union of zygomatic fractures	Procedure: fixation of tripodal zygomatic fractures; One point versus two point fixation of tripodal zygomatic fractures

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
union of fractures	assessment of proper union of fractures	2 months

Collaborators and Investigators

• Sponsor: Mohamed Gamal Thabet
• Investigators: Principal Investigator: Mohamed Gamal, Assiut university

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2020
• Primary Completion (Actual): July 1, 2021
• Study Completion (Actual): August 4, 2021

Study Registration Dates

• First Submitted: December 28, 2019
• First Submitted That Met QC Criteria: December 28, 2019
• First Posted (Actual): January 2, 2020

Study Record Updates

• Last Update Posted (Actual): May 20, 2022
• Last Update Submitted That Met QC Criteria: May 14, 2022
• Last Verified: May 1, 2022

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: Mohamed Gamal Thabet

Plan for Individual participant data (IPD)

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

Study Data/Documents

1. Clinical Study Report
   Information comments: Birgfeld CB, Mundinger GS, Gruss JS. Evidence-based medicine: Evaluation and treatment of zygoma fractures. Plast Reconstr Surg 2017;139(1): 168e-80e.[http://dx.doi.org/10.1097/PRS.0000000000002852] [PMID: 28027253]

Drug and device information, study documents

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