NCT03484676

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2018

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2018

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

March 13, 2018

Completed
20 days until next milestone

First Posted

Study publicly available on registry

April 2, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2018

Completed
Last Updated

April 2, 2018

Status Verified

March 1, 2018

Enrollment Period

4 months

First QC Date

March 13, 2018

Last Update Submit

March 25, 2018

Conditions

Zygomatic Fractures

Outcome Measures

Primary Outcomes (1)

  • Patient satisfaction. Measuring device visual analogue scale. Measuring unit 0-10

    Esthetics and function of patient return post operative. Normal

    One week

Secondary Outcomes (1)

  • Adequacy of reduction compared to the preoperative virtual simulation measuring device mimics software Ware. Measuring unit millimeters

    Immediately post operative

Study Arms (1)

Unilateral Non comminuted zygomatic complex fracture

OTHER

Patient undergo treatment no control group

Device: Titinium

Interventions

TitiniumDEVICE

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

Unilateral Non comminuted zygomatic complex fracture

Eligibility Criteria

Age15 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Patients with comminuted fractures .
  • Delayed presentation 3 weeks or more after the date of trauma.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Zygomatic Fractures

Condition Hierarchy (Ancestors)

Maxillofacial InjuriesFacial InjuriesCraniocerebral TraumaTrauma, Nervous SystemNervous System DiseasesSkull FracturesFractures, BoneWounds and Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Internal resident at Maxillofacial department

Study Record Dates

First Submitted

March 13, 2018

First Posted

April 2, 2018

Study Start

March 1, 2018

Primary Completion

July 1, 2018

Study Completion

October 1, 2018

Last Updated

April 2, 2018

Record last verified: 2018-03