Resorbable Polymer Plates in Repair of Blowout Orbital Floor Fractures

Minia University

Status: Unknown

Conditions: Post-Traumatic Orbital Deformity

Treatments: Procedure: repair of orbital floor fractures using resorbable plates

Study type: Interventional

Funder types: Other

Identifiers

NCT03683615

16111985

Details and patient eligibility

About

It is a prospective study to evaluate the use of resorbable plates for the repair of blow out orbital floor fractures over a follow up period of one year at both cosmetic and functional levels.

Enrollment: 20 estimated patients

Sex: All

Ages: 10 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Class I, II blowout floor fracture.
• Presented within 2 weeks of trauma.
• Have muscle or soft tissue distortion with clinically significant diplopia, enophthalmos or restrictive strabismus.

Exclusion criteria

• Comminuted orbital fractures involving the rim.
• Associated globe injuries.
• Delayed presentation.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

patients with traumatic recent orbital blow out fractures

Other group

Treatment:

Procedure: repair of orbital floor fractures using resorbable plates