- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02332018
Measurements Of Lower Limbs And Spine Based On Biplanar Radiographs: Microdose Compared To Standard Dose Protocol
Two-dimensional And Three-dimensional Measurements Of Torsion And Length Of Lower Limbs And Spine Based On Biplanar Radiographs: Microdose Imaging Protocol Compared To Standard Dose Imaging Protocol
Study Overview
Status
Intervention / Treatment
Detailed Description
Evaluation of accuracy and reliability of 2D and 3D measurements of the spine and lower limbs in adults based on biplanar radiographs with MicroDose protocol compared to a standard dose protocol
Part 1: retrospective evaluation of 50 patients: lower limb images with MicroDose protocol and lower limb images with standard dose protocol Part 2: prospective evaluation of 100 patients: lower limb images with MicroDose protocol and lower limb images with standard dose protocol Part 3: prospective evaluation of 150 patients: spine images with MicroDose protocol and spine limb images with standard dose protocol
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
ZH
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Zurich, ZH, Switzerland, 8008
- Radiology Department, Balgrist University Clinic
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Inclusion: All patients referred for biplanar radiographs of spine and lower limb (from 18 to 99 years of age)
Exclusion Criteria:
- Exclusion criteria: no informed consent
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Limb Torsion
adult patients, lower limb assessment retrospectively limb length and limb axis, torsion biplanar x-ray images
|
biplanar x-ray images with microdose and low-dose protocol
|
Limb Length and Axis
adult patients, lower limb assessment prospectively limb length and limb axis biplanar x-ray images
|
biplanar x-ray images with microdose and low-dose protocol
|
Spine
adult patients, spine assessment prospectively Cobb angles, plumbline biplanar x-ray images
|
biplanar x-ray images with microdose and low-dose protocol
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
2D- and 3D- measurements (torsion angles, scoliotic and kyphotic angles, length etc.) on biplanar radiographs with and without "MicroDose"-protocol and comparison of image quality parameters
Time Frame: 12 month
|
12 month
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Andrea Rosskopf, Balgrist University Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KEK-ZH-Nr.: 2014-0405
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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