Resorbable Polymer Plates in Repair of Blowout Orbital Floor Fractures

• Sponsor: Minia University (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03683615
• Collaborator: Cairo University (Other)
• Enrollment: 20
• Arm: 1
• Anticipated Duration (Months): 33

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Post-Traumatic Orbital Deformity	Procedure: repair of orbital floor fractures using resorbable plates	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Resorbable Polymer Plates in Repair of Blowout Orbital Floor Fractures
• Actual Study Start Date: Jul 1, 2016
• Anticipated Primary Completion Date: Jan 1, 2019
• Anticipated Study Completion Date: Apr 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Other: patients with traumatic recent orbital blow out fractures	Procedure: repair of orbital floor fractures using resorbable plates

Outcome Measures

Primary Outcome Measures

1. 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

1. improvement of symptoms [6 to 12 months]

   improvement of the patient complaints as diplopia and enophthalmos using questionnaire

Eligibility Criteria

Criteria

• Ages Eligible for Study: 10 Years to 50 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Minia University
• Cairo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Tamer Ismail Gawdat, clinical professor, Cairo University
• ClinicalTrials.gov Identifier: NCT03683615
• Other Study ID Numbers: 16111985
• First Posted: Sep 25, 2018
• Last Update Posted: Sep 25, 2018
• Last Verified: Sep 1, 2018

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Tamer Ismail Gawdat, clinical professor, Cairo University: Resorbable, blow out fractures
• Additional relevant MeSH terms: Congenital Abnormalities

Study Results

No Results Posted as of Sep 25, 2018