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Completed

NCT Number: NCT03464318

Low-dose Digital Radiographs in the Idiopathic Scoliosis

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.

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Key information

Conditions

Idiopathic Scoliosis

Age range

9 year–20 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Rizzoli Orthopaedic Institute

Bologna, 40136, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Repeatability and reproducibility

    Time frame: baseline (day 0)

    Repeatability and reproducibility of the Cobb angle measurement

Secondary outcomes

  1. Repeatability and reproducibility

    Time frame: baseline (day 0)

    Repeatability and reproducibility of kyphosis angle, lordosis angle, lumbosacral angle, Nash-Moe rotation index and Risser index measurement

  2. Radiation exposure

    Time frame: baseline (day 0)

    collection of dosimetric data

Sponsors and collaborators

Lead sponsor

Istituto Ortopedico Rizzoli

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Mar 14, 2018
Registry last updated
Sep 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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