Resorbable Polymer Plates in Repair of Blowout Orbital Floor Fractures

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03683615

Enrollment

Registered

2018-09-25

Start date

2016-07-31

Completion date

2019-04-30

Last updated

2018-09-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post-Traumatic Orbital Deformity

Keywords

Resorbable, blow out fractures

Brief summary

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.

Interventions

PROCEDURErepair of orbital floor fractures using resorbable plates

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

10 Years to 50 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
anatomical reduction of the fracture	one month	reduction of the fractured segment and restore the normal orbital volume and contents . assessment of reduction by measuring the changes in the orbital volume using computed tomography

Secondary

Measure	Time frame	Description
improvement of symptoms	6 to 12 months	improvement of the patient complaints as diplopia and enophthalmos using questionnaire

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026