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Low-dose Digital Radiographs in the Idiopathic Scoliosis

Sponsor
Istituto Ortopedico Rizzoli (Other)
Overall Status
Unknown status
CT.gov ID
NCT03464318
Collaborator
(none)
50
Enrollment
1
Location
35.2
Anticipated Duration (Months)
1.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    50 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official Title:
    Repeatability and Reproducibility of Low-dose Digital Radiographs in the Idiopathic Scoliosis
    Actual Study Start Date :
    Jan 27, 2018
    Anticipated Primary Completion Date :
    Jan 1, 2021
    Anticipated Study Completion Date :
    Jan 1, 2021

    Outcome Measures

    Primary Outcome Measures

    1. Repeatability and reproducibility [baseline (day 0)]

      Repeatability and reproducibility of the Cobb angle measurement

    Secondary Outcome Measures

    1. Repeatability and reproducibility [baseline (day 0)]

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

    2. Radiation exposure [baseline (day 0)]

      collection of dosimetric data

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    9 Years to 20 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Rizzoli Orthopaedic Institute Bologna Italy 40136

    Sponsors and Collaborators

    • Istituto Ortopedico Rizzoli

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Milva Battaglia, Principal Investigator, Istituto Ortopedico Rizzoli
    ClinicalTrials.gov Identifier:
    NCT03464318
    Other Study ID Numbers:
    • RXbd17
    First Posted:
    Mar 14, 2018
    Last Update Posted:
    Jan 16, 2019
    Last Verified:
    Jan 1, 2019
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Milva Battaglia, Principal Investigator, Istituto Ortopedico Rizzoli
    idiopathic scoliosis
    radiographs
    low dose
    Additional relevant MeSH terms:
    Scoliosis

    Study Results

    No Results Posted as of Jan 16, 2019