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One Point Versus Two Point Fixation of Tripodal Zygomatic Fractures

Primary Purpose

Assessment of Proper Union of Fractures

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
fixation of tripodal zygomatic fractures
Sponsored by
Mohamed Gamal Thabet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Assessment of Proper Union of Fractures

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • AssiutU

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

union of fractures

Arm Description

proper union of zygomatic fractures

Outcomes

Primary Outcome Measures

union of fractures
assessment of proper union of fractures

Secondary Outcome Measures

Full Information

First Posted
December 28, 2019
Last Updated
May 14, 2022
Sponsor
Mohamed Gamal Thabet
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1. Study Identification

Unique Protocol Identification Number
NCT04214405
Brief Title
One Point Versus Two Point Fixation of Tripodal Zygomatic Fractures
Official Title
One Point Versus Two Point Fixation of Tripodal Zygomatic Fractures
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
February 1, 2020 (Actual)
Primary Completion Date
July 1, 2021 (Actual)
Study Completion Date
August 4, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Mohamed Gamal Thabet

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Assessment of Proper Union of Fractures

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
68 (Actual)

8. Arms, Groups, and Interventions

Arm Title
union of fractures
Arm Type
Experimental
Arm Description
proper union of zygomatic fractures
Intervention Type
Procedure
Intervention Name(s)
fixation of tripodal zygomatic fractures
Intervention Description
One point versus two point fixation of tripodal zygomatic fractures
Primary Outcome Measure Information:
Title
union of fractures
Description
assessment of proper union of fractures
Time Frame
2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamed Gamal
Organizational Affiliation
Assiut University
Official's Role
Principal Investigator
Facility Information:
Facility Name
AssiutU
City
Assiut
ZIP/Postal Code
71111
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No
Available IPD and Supporting Information:
Available IPD/Information Type
Clinical Study Report
Available IPD/Information URL
https://www.ncbi.nlm.nih.gov
Available IPD/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]

Learn more about this trial

One Point Versus Two Point Fixation of Tripodal Zygomatic Fractures

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