Orbital Fractures Measurement: Intraoperative Versus Computed Tomography (CT) Scan

Not Applicable

• Conditions: Orbital Fractures
• Interventions: Procedure: operative fracture size vs CT fracture size; Procedure: orbital fracture intraoperative measurement

• Registration Number: NCT01464541
• Lead Sponsor: HaEmek Medical Center, Israel

Brief Summary

Purpose to compare the orbital fracture size measured by orbital CT scan and compare it to the actual orbital fracture size intraoperatively in patients who needed surgical intervention to correct the fracture.

Hypothesis: there is difference between the CT measure fracture size and the actual intraoperative size.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-10-18
• Study First Submitted QC: 2011-11-02
• Study First Posted: 2011-11-03
• Study Start: 2011-12
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-07
• Last Update Posted: 2016-09-08
• Primary Completion: 2017-08
• Study Completion: 2017-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• With orbital fracture (trauma) proved by CT scan and need operative repair.
• Agree to participate.

Exclusion Criteria

• Patients that refuse to be included in the study.
• Under the age of 18 years.
• CT not performed or not available.
• Not qualified to sign the consent form.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
orbital fractures size	orbital fracture intraoperative measurement	patients who undergo surgical repair of orbital fracture with measuring the fracture size intraoperatively and had available orbital Ct scan preoperatively.
orbital fractures size	operative fracture size vs CT fracture size	patients who undergo surgical repair of orbital fracture with measuring the fracture size intraoperatively and had available orbital Ct scan preoperatively.

Primary Outcome Measures

Name	Time	Method
Patients with orbital fractures that require surgical repair will have their fracture"s" size measured intraoperatively by a ruler and/or a caliper in millimeters and compare it to the size measured by the CT scan.	2 years	Patients with orbital fractures that need to be operated. Their intraoperative fracture size will be measured by the orbital surgeon by a ruler or/and a caliper in millimeters. Size on CT scan is determined by counting the number of slides that show the fracture (for anteropsterior fracture we measure the number of coronal sections that show the fracture multiply X1-each section is 1millimeter thickness, and so on for mediolateral fractures we measure saggital sections number and for superoinferior fractures the axial sections that show the fracture.

Trial Locations

Locations (2)

HaEme Medical center, Dept of Ophthalmology; 🇮🇱 Afula, Israel

HaEmek medical center; 🇮🇱 Afula, North, Israel