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

NCT ID: NCT02332018

Last Updated: 2017-02-20

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

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-07-31

Study Completion Date

2016-01-06

Brief Summary

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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

Detailed Description

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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

Conditions

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Underdevelopment; Congenital Malformation, Lower Limb Scoliosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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Limb Torsion

adult patients, lower limb assessment retrospectively limb length and limb axis, torsion biplanar x-ray images

Biplanar x-ray images

Intervention Type RADIATION

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

Intervention Type RADIATION

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

Intervention Type RADIATION

biplanar x-ray images with microdose and low-dose protocol

Interventions

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Biplanar x-ray images

biplanar x-ray images with microdose and low-dose protocol

Intervention Type RADIATION

Eligibility Criteria

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Inclusion Criteria

* Inclusion: All patients referred for biplanar radiographs of spine and lower limb (from 18 to 99 years of age)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Balgrist University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Andrea Rosskopf

Role: PRINCIPAL_INVESTIGATOR

Balgrist University Hospital

Locations

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Radiology Department, Balgrist University Clinic

Zurich, Canton of Zurich, Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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KEK-ZH-Nr.: 2014-0405

Identifier Type: -

Identifier Source: org_study_id

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