Low-dose Digital Radiographs in the Idiopathic Scoliosis

Completed

• Conditions: Idiopathic Scoliosis

• Registration Number: NCT03464318
• Lead Sponsor: Istituto Ortopedico Rizzoli

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.

Study Timeline

• Study Start: 2018-01-27
• Study First Submitted: 2018-03-07
• Study First Submitted QC: 2018-03-07
• Study First Posted: 2018-03-14
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-22
• Last Update Posted: 2023-09-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 105

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Repeatability and reproducibility	baseline (day 0)	Repeatability and reproducibility of the Cobb angle measurement

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Rizzoli Orthopaedic Institute; 🇮🇹 Bologna, Italy