The Accuracy of Reconstruction of Orbital Walls Fracture Using Prebent Mesh Versus Patient Specific Implant

Tanta University

Status: Completed

Conditions: Orbital Fractures

Treatments: Device: reconstruction of orbital walls

Study type: Interventional

Funder types: Other

Identifiers

NCT06294535

2024

Details and patient eligibility

About

under GA, incision to access to orbital walls. Then insertion of prebent titanium mesh or customized titanium implant and fixation with miniscrews, examination of ocular motility using forced duction test followed by closure of flap.

Full description

under GA, incision to access to orbital walls. complete reflection of orbital floor to be constructed then insertion of customized orbital implant of patient or insertion of titanium mrsh after adaption on the model and fixation with miniscrews, examination of ocular motility using forced duction test followed by closure of flap.

Enrollment: 20 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• patient had fractured orbital walls suffering from enophthalmous, hypoglobus, diplopia

Exclusion criteria

• systemic disease interfere with bone healing enophthamous less than 2 mm

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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20 participants in 2 patient groups

prebent titanium mesh

Experimental group

Description:

reconstruction of fractured orbital walls with perbent titanium mesh

Treatment:

Device: reconstruction of orbital walls

customized titanium implant (patient specific implant)

Experimental group

Description:

econstruction of fractured orbital walls with patient specific implant (customized titanium implant)

Treatment:

Device: reconstruction of orbital walls