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

This study is currently recruiting participants.
Verified September 2016 by HaEmek Medical Center, Israel
Sponsor:
ClinicalTrials.gov Identifier:
NCT01464541
First Posted: November 3, 2011
Last Update Posted: September 8, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
HaEmek Medical Center, Israel
  Purpose

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 Intervention
Orbital Fractures Procedure: operative fracture size vs CT fracture size Procedure: orbital fracture intraoperative measurement

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)

Resource links provided by NLM:


Further study details as provided by HaEmek Medical Center, Israel:

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. [ Time Frame: 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.


Estimated Enrollment: 20
Study Start Date: December 2011
Estimated Study Completion Date: August 2017
Estimated Primary Completion Date: August 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01464541


Contacts
Contact: Daniel Briscoe, MD 972504439421 daniel_br@clalit.org.il

Locations
Israel
HaEmek medical center Not yet recruiting
Afula, North, Israel, 18101
Contact: Daniel Briscoe, MD    972504439421    daniel_br@clalit.org.il   
Contact: Wasseem Hilo, MD    972544556428    wasseem_h@clalit.org.il   
HaEme Medical center, Dept of Ophthalmology Recruiting
Afula, Israel, 18101
Contact: Daniel Briscoe, MD    972504439421    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         
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
  More Information

Responsible Party: HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier: NCT01464541     History of Changes
Other Study ID Numbers: EMC-0046-11
First Submitted: October 18, 2011
First Posted: November 3, 2011
Last Update Posted: September 8, 2016
Last Verified: September 2016

Keywords provided by HaEmek Medical Center, Israel:
Orbit
Fracture
measurement
CT
intraoperative

Additional relevant MeSH terms:
Fractures, Bone
Orbital Fractures
Wounds and Injuries
Maxillofacial Injuries
Facial Injuries
Craniocerebral Trauma
Trauma, Nervous System
Nervous System Diseases
Skull Fractures


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