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

NCT01464541 | Unknown

• 1 other identifier: EMC-0046-11
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

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.

Conditions

Orbital Fractures

Keywords

Orbit; Fracture; measurement; CT; intraoperative

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

orbital fractures size

EXPERIMENTAL

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; Procedure: orbital fracture intraoperative measurement

Interventions

operative fracture size vs CT fracture size PROCEDURE

comparing actual intraoperative fracture size to the CT fracture size

orbital fractures size

orbital fracture intraoperative measurement PROCEDURE

comparing intraoperative fracture size to the CT orbital fracture size

orbital fractures size

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• With orbital fracture (trauma) proved by CT scan and need operative repair.
• Agree to participate.

You may not qualify if:

• 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.

Sponsors & Collaborators

• HaEmek Medical Center, Israel: lead

Study Sites (2)

HaEmek medical center

Afula, North, 18101, Israel

NOT YET RECRUITING

HaEme Medical center, Dept of Ophthalmology

Afula, 18101, Israel

RECRUITING

MeSH Terms

Conditions

Orbital Fractures; Fractures, Bone

Condition Hierarchy (Ancestors)

Maxillofacial Injuries; Facial Injuries; Craniocerebral Trauma; Trauma, Nervous System; Nervous System Diseases; Skull Fractures; Wounds and Injuries

Study Officials

• Daniel Briscoe, MD

  Chairperson, dept. of ophthalmology, haemek medical center, afula 18101, Israel

  PRINCIPAL INVESTIGATOR

• Wasseem Hilo, MD

  Resident, ophthalmology dept, Haemek Medical Center, Afula 18101, Israel

  STUDY DIRECTOR

Central Study Contacts

Daniel Briscoe, MD

CONTACT

972504439421; daniel_br@clalit.org.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2011
• First Posted: November 3, 2011
• Study Start: December 1, 2011
• Primary Completion: August 1, 2017
• Study Completion: August 1, 2017
• Last Updated: September 8, 2016

Record last verified: 2016-09

Locations

IL (2)