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

Completed

• Conditions: Underdevelopment; Congenital Malformation, Lower Limb; Scoliosis
• Interventions: Radiation: Biplanar x-ray images

• Registration Number: NCT02332018
• Lead Sponsor: Balgrist University Hospital

Brief Summary

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

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 Timeline

• Study Start: 2014-07
• Study First Submitted: 2015-01-05
• Study First Submitted QC: 2015-01-05
• Study First Posted: 2015-01-06
• Primary Completion: 2016-01-06
• Study Completion: 2016-01-06
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-17
• Last Update Posted: 2017-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Limb Length and Axis	Biplanar x-ray images	adult patients, lower limb assessment prospectively limb length and limb axis biplanar x-ray images
Spine	Biplanar x-ray images	adult patients, spine assessment prospectively Cobb angles, plumbline biplanar x-ray images
Limb Torsion	Biplanar x-ray images	adult patients, lower limb assessment retrospectively limb length and limb axis, torsion biplanar x-ray images

Primary Outcome Measures

Name	Time	Method
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	12 month

Trial Locations

Locations (1)

Radiology Department, Balgrist University Clinic; 🇨🇭 Zurich, ZH, Switzerland