Low-dose Digital Radiographs in the Idiopathic Scoliosis

September 22, 2023 updated by: Istituto Ortopedico Rizzoli

Repeatability and Reproducibility of 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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

105

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Bologna, Italy, 40136
        • Rizzoli Orthopaedic Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

9 years to 20 years (Child, Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

patients with suspected or known idiopathic scoliosis selected at the Rizzoli Orthopaedic Institute

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Repeatability and reproducibility
Time Frame: baseline (day 0)
Repeatability and reproducibility of the Cobb angle measurement
baseline (day 0)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
baseline (day 0)
Radiation exposure
Time Frame: baseline (day 0)
collection of dosimetric data
baseline (day 0)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituto Ortopedico Rizzoli

Investigators

  • Principal Investigator: Milva Battaglia, MD, Rizzoli Orthopaedic Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 27, 2018

Primary Completion (Actual)

December 31, 2019

Study Completion (Actual)

December 31, 2019

Study Registration Dates

First Submitted

March 7, 2018

First Submitted That Met QC Criteria

March 7, 2018

First Posted (Actual)

March 14, 2018

Study Record Updates

Last Update Posted (Actual)

September 26, 2023

Last Update Submitted That Met QC Criteria

September 22, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RXbd17

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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