Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2025-12-26 @ 3:58 AM
Study NCT ID:
NCT03464318
Status:
COMPLETED
Last Update Posted:
2023-09-26
First Post:
2018-03-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Low-dose Digital Radiographs in the Idiopathic Scoliosis
Sponsor:
Istituto Ortopedico Rizzoli
Organization:
Study Overview
Official Title:
Repeatability and Reproducibility of Low-dose Digital Radiographs in the Idiopathic Scoliosis
Status:
COMPLETED
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: