Clincosm LogoSign in Get a demo

Adequacy of One Point Fixation of Displaced Zygomatic Complex Fracture

Sponsor
Cairo University (Other)
Overall Status
Unknown status
CT.gov ID
NCT03484676
Collaborator
(none)
18
Enrollment
1
Arm
7
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

Patients with unilateral non-comminuted zygomatic complex fracture undergo fixation of the complex by a customized plate at one point after 3D virtual simulation and reduction of the complex using Mimics software.

Condition or Disease Intervention/Treatment Phase
  • Device: Titinium
 N/A

Detailed Description

History data will be gathered including personal data, medical and surgical history, and family history.

Clinical examination and photographic records will be carried out to evaluate the magnitude and direction of the displaced zygoma, degree of facial asymmetry, neurosensory affection and functional disturbances.

Computed tomography (CT) scan:

Patients will receive a preoperative computed tomography (CT) scan of the facial bones [ Axial cuts, DICOM file, Gantry tilt zero and minimal thickness of 1 mm]. The radiographic data will be imported into a surgical simulation software to virtually reduce the fractured zygoma and custom design the plate for fixation.

General operative procedures:

  • All cases will undergo surgery under general anesthesia with nasotracheal intubation.

  • Intraoral maxillary vestibular approach will be used to gain access to the fractured zygomatic complex. Reduction of the fractured segment would be achieved using the appropriate techniques and instrumentation. One point ORIF would be accomplished using the customized plate.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
18 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Adequacy of One-Point Fixation of Displaced Zygomatic Complex Fractures Using a Customized Plate pre_post Study
Anticipated Study Start Date :
Mar 1, 2018
Anticipated Primary Completion Date :
Jul 1, 2018
Anticipated Study Completion Date :
Oct 1, 2018

Arms and Interventions

Arm Intervention/Treatment
Other: Unilateral Non comminuted zygomatic complex fracture

Patient undergo treatment no control group

Device: Titinium
custom made plate at one point after 3D virtual simulation and reduction of the complex using Mimics software.

Outcome Measures

Primary Outcome Measures

  1. Patient satisfaction. Measuring device visual analogue scale. Measuring unit 0-10 [One week]

    Esthetics and function of patient return post operative. Normal

Secondary Outcome Measures

  1. Adequacy of reduction compared to the preoperative virtual simulation measuring device mimics software Ware. Measuring unit millimeters [Immediately post operative]

    Reduction of fracture on mimics soft ware depending on 3d virtual simulation and mirror image of the same patient and after operation I will compare post operative reduction to preoperative reduction on mimics soft ware in millimeters measuring unit

Eligibility Criteria

Criteria

Ages Eligible for Study:
15 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Patients' age range from 15-65 years.

  • Patients with unilateral zygomatic complex fracture

  • Displaced fracture

  • Dentulous or edentulous patients.

  • Patients should be free from any systemic disease that may affect normal healing of bone and predictable outcome.

Exclusion Criteria. Patients with systemic diseases as history of radiation therapy or chemotherapy, hematological disorders, neuromotor disorders and autoimmune diseases (may affect normal healing).

  • Patients with comminuted fractures .

  • Delayed presentation 3 weeks or more after the date of trauma.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Cairo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ahmed Ashour Saad Borma, Internal resident at Maxillofacial department, Cairo University
ClinicalTrials.gov Identifier:
NCT03484676
Other Study ID Numbers:
  • CEBD-CU-2018-03-17
First Posted:
Apr 2, 2018
Last Update Posted:
Apr 2, 2018
Last Verified:
Mar 1, 2018
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Zygomatic Fractures
Fractures, Bone

Study Results

No Results Posted as of Apr 2, 2018