Low-dose Digital Radiographs in the Idiopathic Scoliosis

Repeatability and Reproducibility of Low-dose Digital Radiographs in the Idiopathic Scoliosis

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03464318

Enrollment

105

Registered

2018-03-14

Start date

2018-01-27

Completion date

2019-12-31

Last updated

2023-09-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Idiopathic Scoliosis

Keywords

idiopathic scoliosis, radiographs, low dose

Brief summary

The aim of the study is to evaluate the intraobserver repeatability and the interobserver reproducibility of low-dose radiographs with a HELIOS DRF (CAT) imaging system in patients with idiopathic scoliosis.

Detailed description

The 80% of scoliosis is idiopathic and begins mostly in adolescence (10-20 years). The young patients need to undergo several radiographic controls for a correct therapeutic balance. However, the repeated radiation exposures is associated with a greater risk of carcinogenesis even if reduced with a digital imaging technique. The aim of this study is to evaluate the intraobserver repeatability and the interobserver reproducibility of low-dose radiographs with a HELIOS DRF (CAT) imaging system in patients with idiopathic scoliosis.

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

9 Years to 20 Years

Healthy volunteers

Inclusion criteria

* patients with suspected or known idiopathic scoliosis * patients able to maintain orthostasis without medical devices * patients from 9 to 20 years old

Exclusion criteria

* patients with known congenital, syndromic, neurological scoliosis * patients not able to maintain orthostasis * obese patients * low back pain or known tumor pathology * patients with vertebral arthrodesis * patients younger than 9 years old, or older than 20 years old

Design outcomes

Primary

Measure	Time frame	Description
Repeatability and reproducibility	baseline (day 0)	Repeatability and reproducibility of the Cobb angle measurement

Secondary

Measure	Time frame	Description
Repeatability and reproducibility	baseline (day 0)	Repeatability and reproducibility of kyphosis angle, lordosis angle, lumbosacral angle, Nash-Moe rotation index and Risser index measurement
Radiation exposure	baseline (day 0)	collection of dosimetric data

Countries

Italy

Outcome results