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

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.

Study Overview

• Status: Unknown
• Conditions: Orbital Fractures
• Intervention / Treatment: Procedure: operative fracture size vs CT fracture size; Procedure: orbital fracture intraoperative measurement

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Daniel Briscoe, MD; Phone Number: 972504439421; Email: daniel_br@clalit.org.il

Study Locations

• Israel
  • Afula, Israel, 18101
    • Recruiting
    • HaEme Medical center, Dept of Ophthalmology
    • Contact: Daniel Briscoe, MD; Phone Number: 972504439421; Email: daniel_br@clalit.org.il
    • Sub-Investigator: Haneen Jabaly-Habib, MD
    • Sub-Investigator: Olga Zurinam, MD
    • Sub-Investigator: Ilan Feldman, MD
    • Sub-Investigator: Shireen Hamed-Azzam, MD
  • North
    • Afula, North, Israel, 18101
      • Not yet recruiting
      • Haemek Medical Center
      • Contact: Daniel Briscoe, MD; Phone Number: 972504439421; Email: daniel_br@clalit.org.il
      • Contact: Wasseem Hilo, MD; Phone Number: 972544556428; Email: wasseem_h@clalit.org.il

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: 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

Study record dates

Study Major Dates

• Study Start: December 1, 2011
• Primary Completion (Anticipated): August 1, 2017
• Study Completion (Anticipated): August 1, 2017

Study Registration Dates

• First Submitted: October 18, 2011
• First Submitted That Met QC Criteria: November 2, 2011
• First Posted (Estimate): November 3, 2011

Study Record Updates

• Last Update Posted (Estimate): September 8, 2016
• Last Update Submitted That Met QC Criteria: September 7, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Keywords: CT; Fracture; measurement; intraoperative; Orbit
• Additional Relevant MeSH Terms: Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Maxillofacial Injuries; Facial Injuries; Skull Fractures; Fractures, Bone; Orbital Fractures
• Other Study ID Numbers: EMC-0046-11