NCT05439512

Brief Summary

The aim of the study is to evaluate the feasibility of CAD/CAM osteosynthesis mesh through a transantral surgical approach in the Repair of orbital floor fractures by means of clinical and radiographic findings.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
7

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

August 1, 2021

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

June 26, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 30, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 5, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 27, 2023

Completed
Last Updated

February 7, 2024

Status Verified

February 1, 2024

Enrollment Period

1.8 years

First QC Date

June 26, 2022

Last Update Submit

February 5, 2024

Conditions

Orbital Fractures

Outcome Measures

Primary Outcomes (1)

  • enophthamus

    will calculate the amount of alteration and quantity of Enophthalmos by mean of a Post-Op Soft window CT scan in mm

    6 months

Study Arms (1)

orbital floor fracture

EXPERIMENTAL

orbital floor fracture

Procedure: transantral orbital floor reconstruction by titanium mesh

Interventions

transantral orbital floor reconstruction by titanium meshPROCEDURE

reconstruction of orbital floor fracture by patient specific titanium mesh

Also known as: trans antral orbital floor reconstruction
orbital floor fracture

Eligibility Criteria

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

You may qualify if:

  • Patients with recent unilateral orbital floor fracture indicated for internal reconstruction -
  • (isolated or in combination with other facial fractures)
  • with existing or estimated enophthalmos based on radiographs and a contra-lateral healthy non-operated orbit.

You may not qualify if:

  • Delayed cases (more than 2 weeks)
  • previously operated cases
  • bilateral orbital floor fracture.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry,Cairo University

Cairo, Egypt

Location

MeSH Terms

Conditions

Orbital 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
principal investigator

Study Record Dates

First Submitted

June 26, 2022

First Posted

June 30, 2022

Study Start

August 1, 2021

Primary Completion

June 5, 2023

Study Completion

July 27, 2023

Last Updated

February 7, 2024

Record last verified: 2024-02

Locations

EG(1)