Orbital FracturesNCT01464541
Orbital Fractures Measurement: Intraoperative Versus Computed Tomography (CT) Scan
A study testing operative fracture size vs CT fracture size and orbital fracture intraoperative measurement in people with Orbital Fractures, run by HaEmek Medical Center, Israel at 2 sites in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Orbital Fractures
- What is being tested?
- operative fracture size vs CT fracture size and orbital fracture intraoperative measurement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesIsrael
- Study dates
- Dec 2011to Aug 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- With orbital fracture (trauma) proved by CT scan and need operative repair.
- Agree to participate.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Israel2 sites, 2 recruiting
- Not yet recruiting
HaEmek medical center
Afula, North, 18101
Daniel Briscoe, MD, 972504439421, daniel_br@clalit.org.il
Wasseem Hilo, MD, 972544556428, wasseem_h@clalit.org.il
- Recruiting
HaEme Medical center, Dept of Ophthalmology
Afula, 18101
Daniel Briscoe, MD, 972504439421, daniel_br@clalit.org.il
Haneen Jabaly-Habib, MD
About this study
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
- Being tested
- operative fracture size vs CT fracture size, orbital fracture intraoperative measurement
- Keywords
- Orbit, Fracture, measurement, CT, intraoperative
- Medical subject headings
- Orbital Fractures, Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
operative fracture size vs CT fracture sizeProcedure or surgery
comparing actual intraoperative fracture size to the CT fracture size
orbital fracture intraoperative measurementProcedure or surgery
comparing intraoperative fracture size to the CT orbital fracture size
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: operative fracture size vs CT fracture size; Procedure: orbital fracture intraoperative measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2011 (estimated)
- Study startDec 2011
- Primary completionAug 2017 (estimated)
- Study completionAug 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orbital FracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HaEmek Medical Center, Israel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel Briscoe, MD, Principal investigator, Chairperson, dept. of ophthalmology, haemek medical center, afula 18101, IsraelWasseem Hilo, MD, Study director, Resident, ophthalmology dept, Haemek Medical Center, Afula 18101, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01464541
- Sponsor's protocol ID
- EMC-0046-11
- Status last verified
- Sep 2016
- First submitted
- 18 Oct 2011
- Last updated
- 8 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Orbital Fractures Measurement: Intraoperative Versus Computed Tomography (CT) Scan
- ClinicalTrials.gov ID
- NCT01464541
- Acronym / sponsor ID
- EMC-0046-11
- Conditions
- Orbital Fractures
- Keywords
- Orbit, Fracture, measurement, CT, intraoperative
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- HaEmek Medical Center, IsraelUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Aug 2017 (estimated)
- Study completion
- Aug 2017 (estimated)
- First posted
- 3 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| orbital fractures size | Experimental | Procedure: operative fracture size vs CT fracture size, Procedure: orbital fracture intraoperative measurementpatients who undergo surgical repair of orbital fracture with measuring the fracture size intraoperatively and had available orbital Ct scan preoperatively. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- With orbital fracture (trauma) proved by CT scan and need operative repair.
- Agree to participate.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| operative fracture size vs CT fracture sizecomparing actual intraoperative fracture size to the CT fracture size | Procedure or surgery | orbital fractures size |
| orbital fracture intraoperative measurementcomparing intraoperative fracture size to the CT orbital fracture size | Procedure or surgery | orbital fractures size |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2016.
Related trials for Orbital Fractures
Recruiting
Comparing Pre-adaptation of In-stock Mesh Over In-house 3D Patient Specific Model to Reconstruct Unilateral Primary Orbital Fracture With and Without Intraoperative Navigation vs Conventional Intraoperative Free-hand Mesh Bending
Orbital Fractures, Unilateral
Not yet recruitingObservational study
Epidemiological and Statistical Study of Facial Traumatic Fractures at Assiut University Trauma Hospital
Facial Fractures, Maxillofacial Injuries
Not yet recruiting
A Trial to Evaluate Two Ectropion Preventive Measures Using the Subciliary Approach in Orbital Fracture Surgery.
Orbital Fractures, Orbital Floor Fractures
Recruiting
Clinical Outcomes of Transconjunctival Vs Transcutaneous Approaches in Orbital Fracture Repair
Orbital Fractures
Active, not recruitingObservational study
Orbital Fractures Registry
Orbital Fractures, Blow Out Fracture of Orbit
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Briscoe, MD principal investigator
Chairperson, dept. of ophthalmology, haemek medical center, afula 18101, Israel
Wasseem Hilo, MD study director
Resident, ophthalmology dept, Haemek Medical Center, Afula 18101, Israel
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing operative fracture size vs CT fracture size and orbital fracture intraoperative measurement in people with Orbital Fractures, run by HaEmek Medical Center, Israel at 2 sites in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Daniel Briscoe, MD (972504439421, daniel_br@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2016.