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Low-dose Digital Radiographs in the Idiopathic Scoliosis

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ClinicalTrials.gov Identifier: NCT03464318
Recruitment Status : Recruiting
First Posted : March 14, 2018
Last Update Posted : March 15, 2018
Sponsor:
Information provided by (Responsible Party):
Milva Battaglia, Istituto Ortopedico Rizzoli

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
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.


Study Type : Observational
Estimated 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 : January 27, 2018
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scoliosis X-Rays




Primary Outcome Measures :
  1. Repeatability and reproducibility [ Time Frame: baseline (day 0) ]
    Repeatability and reproducibility of the Cobb angle measurement


Secondary Outcome Measures :
  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



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Ages Eligible for Study:   9 Years to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients with suspected or known idiopathic scoliosis selected at the Rizzoli Orthopaedic Institute
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03464318


Contacts
Contact: Milva Battaglia, MD +390516366181 milva.battaglia@ior.it

Locations
Italy
Rizzoli Orthopaedic Institute Recruiting
Bologna, Italy, 40136
Contact: Tiziana Greggi, MD    +390516366430    tiziana.greggi@ior.it   
Sponsors and Collaborators
Istituto Ortopedico Rizzoli
Investigators
Principal Investigator: Milva Battaglia, MD Rizzoli Orthopaedic Institute

Responsible Party: Milva Battaglia, Principal Investigator, Istituto Ortopedico Rizzoli
ClinicalTrials.gov Identifier: NCT03464318     History of Changes
Other Study ID Numbers: RXbd17
First Posted: March 14, 2018    Key Record Dates
Last Update Posted: March 15, 2018
Last Verified: March 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Milva Battaglia, Istituto Ortopedico Rizzoli:
idiopathic scoliosis
radiographs
low dose

Additional relevant MeSH terms:
Scoliosis
Spinal Curvatures
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases