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

This study is not yet open for participant recruitment.
Verified November 2011 by HaEmek Medical Center, Israel
Sponsor:
Information provided by (Responsible Party):
HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier:
NCT01464541
First received: October 18, 2011
Last updated: November 2, 2011
Last verified: November 2011
History of Changes
  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: Open Label

Resource links provided by NLM:

U.S. FDA Resources

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 ] [ Designated as safety issue: Yes ]
    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 Primary Completion Date: November 2013 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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 Not yet 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

No publications provided

Responsible Party: HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier: NCT01464541     History of Changes
Other Study ID Numbers: EMC-0046-11
Study First Received: October 18, 2011
Last Updated: November 2, 2011
Health Authority: Israel: Ethics Commission

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
Skull Fractures

ClinicalTrials.gov processed this record on June 17, 2013