NCT05673473

Brief Summary

Radiographical images in Adolescent idiopathic scoliosis (AIS) can have a potential radiation-induced oncogenic effect. In this study, the investigators aim to compare a fluoroscopic imaging technique (LFT) with traditional radiographs for scoliosis (ORT), to see if LFT is adequate for clinical evaluation of AIS and having a lower radiation dose. Method Image quality will evaluated for LTF and ORT of phantom images and images from 3D printed models of AIS. The investigators will measure primary physical characteristics of noise, contrast, spatial resolution, SNR, and CNR. Three independent raters will evaluate the images by observer-based methods of ICS and VGAS. Radiation doses will be evaluated by DAP measurements. Two raters will perform measurements of 6 radiographic parameters for the LFT images of AIS

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
342

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2016

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 20, 2020

Completed
2.5 years until next milestone

First Posted

Study publicly available on registry

January 6, 2023

Completed
Last Updated

January 19, 2023

Status Verified

January 1, 2023

Enrollment Period

3.9 years

First QC Date

June 20, 2020

Last Update Submit

January 18, 2023

Conditions

ScoliosisRadiation ExposureEvaluable

Keywords

Adolescent idiopathic scoliosisLow dose fluoroscopic imaging techniqueImage quality evaluationDose measurements.Cobb's angle

Outcome Measures

Primary Outcomes (2)

  • cobb's angle

    radiographic curve severity evaluation between 2 evaluators with evaluation of the radiographs

    from study initiation to risser 4 and up to 24 months fro all participants

  • cobbs angle 2

    radiographic curve severity evaluation between 3 measurements with different models

    with positioning and repositionning

Interventions

scoliosis radiographsRADIATION

Low dose fluoroscopic imaging technique for scoliosis x-rays

Eligibility Criteria

Age7 Years - 17 Years
Sexall
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

. One hundred thirty-six adolescent patients with AIS were included as participants

You may qualify if:

  • The LFT was our regular clinical routine radiographic method for AIS.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Scoliosis

Condition Hierarchy (Ancestors)

Spinal CurvaturesSpinal DiseasesBone DiseasesMusculoskeletal Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
principle investigator

Study Record Dates

First Submitted

June 20, 2020

First Posted

January 6, 2023

Study Start

January 1, 2016

Primary Completion

December 1, 2019

Study Completion

January 1, 2020

Last Updated

January 19, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Regular clinical followup