Low-dose Digital Radiographs in the Idiopathic Scoliosis

NCT ID: NCT03464318

Last Updated: 2023-09-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

105 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-27

Study Completion Date

2019-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Idiopathic Scoliosis

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

9 Years

Maximum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Istituto Ortopedico Rizzoli

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Milva Battaglia, MD

Role: PRINCIPAL_INVESTIGATOR

Rizzoli Orthopaedic Institute

Locations

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Rizzoli Orthopaedic Institute

Bologna, , Italy

Site Status

Countries

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Italy

Other Identifiers

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RXbd17

Identifier Type: -

Identifier Source: org_study_id

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