Measurements Of Lower Limbs And Spine Based On Biplanar Radiographs: Microdose Compared To Standard Dose Protocol

February 17, 2017 updated by: Balgrist University Hospital

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

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

Study Overview

Status

Completed

Conditions

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

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
    • ZH
      • Zurich, ZH, Switzerland, 8008
        • Radiology Department, Balgrist University Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult patients referred for assessment of spine or lower limb with biplanar x-ray-scanner

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Radiation: 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
Radiation: 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
Radiation: 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

This is where you will find people and organizations involved with this study.

Sponsor

Balgrist University Hospital

Investigators

  • Principal Investigator: Andrea Rosskopf, Balgrist University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2014

Primary Completion (Actual)

January 6, 2016

Study Completion (Actual)

January 6, 2016

Study Registration Dates

First Submitted

January 5, 2015

First Submitted That Met QC Criteria

January 5, 2015

First Posted (Estimate)

January 6, 2015

Study Record Updates

Last Update Posted (Actual)

February 20, 2017

Last Update Submitted That Met QC Criteria

February 17, 2017

Last Verified

February 1, 2017

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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