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

Orbital Fractures Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01464541
• Other study ID #: EMC-0046-11
• Status: Recruiting
• Phase: N/A
• First received: October 18, 2011
• Last updated: September 7, 2016
• Start date: December 2011
• Est. completion date: August 2017

Study information

• Verified date: September 2016
• Source: HaEmek Medical Center, Israel
• Contact: Daniel Briscoe, MD
• Phone: 972504439421
• Email: daniel_br[@]clalit.org.il
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: August 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Fractures, Bone
• Orbital Fractures

Intervention

Procedure:
• operative fracture size vs CT fracture size
comparing actual intraoperative fracture size to the CT fracture size
• orbital fracture intraoperative measurement
comparing intraoperative fracture size to the CT orbital fracture size

Locations

Country	Name	City	State
Israel	HaEme Medical center, Dept of Ophthalmology	Afula
Israel	HaEmek medical center	Afula	North

Sponsors (1)

Lead Sponsor	Collaborator
HaEmek Medical Center, Israel

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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.	2 years	Yes