Orbital Floor Fracture Repair by Titanium Mesh Via Transantral Approach.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-01

Study Completion Date

2023-07-27

Brief Summary

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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.

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Detailed Description

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A CAD/CAM osteosynthesis mesh through a transantral approach should assumingly provide accurate reconstruction of the orbital volume and anatomy while eliminating the usual morbidity of lower eyelid approaches during orbital reconstruction.

Conditions

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Orbital Fractures

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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orbital floor fracture

Group Type EXPERIMENTAL

transantral orbital floor reconstruction by titanium mesh

Intervention Type PROCEDURE

reconstruction of orbital floor fracture by patient specific titanium mesh

Interventions

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transantral orbital floor reconstruction by titanium mesh

reconstruction of orbital floor fracture by patient specific titanium mesh

Intervention Type PROCEDURE

Other Intervention Names

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trans antral orbital floor reconstruction

Eligibility Criteria

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Inclusion Criteria

* 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.