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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03464318
Other study ID # RXbd17
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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)
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