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

Sponsor

HaEmek Medical Center, Israel (Other)

Overall Status

Unknown status

CT.gov ID

NCT01464541

Collaborator

(none)

Enrollment

Locations

Arm

Duration (Months)

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Orbital Fractures	Procedure: operative fracture size vs CT fracture size Procedure: orbital fracture intraoperative measurement	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Study Start Date :

Dec 1, 2011

Anticipated Primary Completion Date :

Aug 1, 2017

Anticipated Study Completion Date :

Aug 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: orbital fractures size patients who undergo surgical repair of orbital fracture with measuring the fracture size intraoperatively and had available orbital Ct scan preoperatively.	Procedure: operative fracture size vs CT fracture size comparing actual intraoperative fracture size to the CT fracture size Procedure: orbital fracture intraoperative measurement comparing intraoperative fracture size to the CT orbital fracture size

Arm

Intervention/Treatment

Experimental: orbital fractures size

patients who undergo surgical repair of orbital fracture with measuring the fracture size intraoperatively and had available orbital Ct scan preoperatively.

Procedure: operative fracture size vs CT fracture size

comparing actual intraoperative fracture size to the CT fracture size

Procedure: orbital fracture intraoperative measurement

comparing intraoperative fracture size to the CT orbital fracture size

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	HaEmek medical center	Afula	North	Israel	18101
2	HaEme Medical center, Dept of Ophthalmology	Afula		Israel	18101

Sponsors and Collaborators

HaEmek Medical Center, Israel

Investigators

Principal Investigator: Daniel Briscoe, MD, Chairperson, dept. of ophthalmology, haemek medical center, afula 18101, Israel
Study Director: Wasseem Hilo, MD, Resident, ophthalmology dept, Haemek Medical Center, Afula 18101, Israel