Low-dose Digital Radiographs in the Idiopathic Scoliosis | NCT03464318

Studies
Low-dose Digital Radiographs in the Idiopathic Scoliosis

NCT03464318

Sponsor

Istituto Ortopedico Rizzoli

Status

Completed

Last Update Posted

Sep 26, 2023Actual

Enrollment

105Actual

Phase

Not provided

Conditions

Idiopathic Scoliosis

Interventions

Not provided

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 27, 2018Actual

Primary Completion Date

Dec 31, 2019Actual

Completion Date

Dec 31, 2019Actual

First Submitted Date

Mar 7, 2018

First Submission Date that Met QC Criteria

Mar 7, 2018

First Posted Date

Mar 14, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 22, 2023

Last Update Posted Date

Sep 26, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

105Actual

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Repeatability and reproducibility	Repeatability and reproducibility of kyphosis angle, lordosis angle, lumbosacral angle, Nash-Moe rotation index and Risser index measurement	baseline (day 0)
Radiation exposure

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

9 Years

Maximum Age

20 Years

Standard Ages

ChildAdult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Milva Battaglia, MD	Rizzoli Orthopaedic Institute	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rizzoli Orthopaedic Institute		Bologna		40136	Italy