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

NCT ID: NCT01464541

Last Updated: 2016-09-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

Study Completion Date

2017-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Orbital Fractures

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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orbital fractures size

patients who undergo surgical repair of orbital fracture with measuring the fracture size intraoperatively and had available orbital Ct scan preoperatively.

Group Type EXPERIMENTAL

operative fracture size vs CT fracture size

Intervention Type PROCEDURE

comparing actual intraoperative fracture size to the CT fracture size

orbital fracture intraoperative measurement

Intervention Type PROCEDURE

comparing intraoperative fracture size to the CT orbital fracture size

Interventions

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operative fracture size vs CT fracture size

comparing actual intraoperative fracture size to the CT fracture size

Intervention Type PROCEDURE

orbital fracture intraoperative measurement

comparing intraoperative fracture size to the CT orbital fracture size

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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HaEmek Medical Center, Israel

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Daniel Briscoe, MD

Role: PRINCIPAL_INVESTIGATOR

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

Wasseem Hilo, MD

Role: STUDY_DIRECTOR

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

Locations

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HaEmek medical center

Afula, North, Israel

Site Status NOT_YET_RECRUITING

HaEme Medical center, Dept of Ophthalmology

Afula, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Daniel Briscoe, MD

Role: CONTACT

972504439421

Facility Contacts

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Daniel Briscoe, MD

Role: primary

972504439421

Wasseem Hilo, MD

Role: backup

972544556428

Daniel Briscoe, MD

Role: primary

972504439421

Other Identifiers

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EMC-0046-11

Identifier Type: -

Identifier Source: org_study_id

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