NCT03464318

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
105

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 27, 2018

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 7, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 14, 2018

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

September 26, 2023

Status Verified

September 1, 2023

Enrollment Period

1.9 years

First QC Date

March 7, 2018

Last Update Submit

September 22, 2023

Conditions

Idiopathic Scoliosis

Keywords

idiopathic scoliosisradiographslow dose

Outcome Measures

Primary Outcomes (1)

  • Repeatability and reproducibility

    Repeatability and reproducibility of the Cobb angle measurement

    baseline (day 0)

Secondary Outcomes (2)

  • Repeatability and reproducibility

    baseline (day 0)

  • Radiation exposure

    baseline (day 0)

Eligibility Criteria

Age9 Years - 20 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • patients with suspected or known idiopathic scoliosis
  • patients able to maintain orthostasis without medical devices
  • patients from 9 to 20 years old

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rizzoli Orthopaedic Institute

Bologna, 40136, Italy

Location

Study Officials

  • Milva Battaglia, MD

    Rizzoli Orthopaedic Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 7, 2018

First Posted

March 14, 2018

Study Start

January 27, 2018

Primary Completion

December 31, 2019

Study Completion

December 31, 2019

Last Updated

September 26, 2023

Record last verified: 2023-09

Locations

IT(1)