Resorbable Polymer Plates in Repair of Blowout Orbital Floor Fractures
Not Applicable
- Conditions
- Post-Traumatic Orbital Deformity
- Registration Number
- NCT03683615
- Lead Sponsor
- Minia University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 20
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method improvement of symptoms 6 to 12 months improvement of the patient complaints as diplopia and enophthalmos using questionnaire