Low-dose Digital Radiographs in the Idiopathic Scoliosis

Idiopathic Scoliosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03464318
• Other study ID #: RXbd17
• Status: Completed
• Start date: January 27, 2018
• Est. completion date: December 31, 2019

Study information

• Verified date: September 2023
• Source: Istituto Ortopedico Rizzoli
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 9 Years to 20 Years

Eligibility

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

Related Conditions & MeSH terms

• Idiopathic Scoliosis
• Scoliosis

Locations

Country	Name	City	State
Italy	Rizzoli Orthopaedic Institute	Bologna

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Ortopedico Rizzoli

Country where clinical trial is conducted

Italy, 

Outcome

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