NCT03483844

Brief Summary

The aim of the study is to evaluate the diagnostic accuracy of low-dose dual energy CT in the pre-surgical planning of patients with progression of scoliosis

Trial Health

87
On Track

Trial Health Score

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

Enrollment
64

participants targeted

Target at P25-P50 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 16, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 7, 2018

Completed
23 days until next milestone

First Posted

Study publicly available on registry

March 30, 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

2 years

First QC Date

March 7, 2018

Last Update Submit

September 22, 2023

Conditions

Scoliosis

Keywords

scoliosislow dosearthrodesisdual-energy CT

Outcome Measures

Primary Outcomes (1)

  • Diagnostic accuracy

    To evaluate the percentage of malpositioning of transpedicular screw. A percentage of malpositioning lower than 10% will be considered as acceptable.

    Week 1 (post-surgery)

Secondary Outcomes (1)

  • Radiation exposure

    Baseline (pre-surgery) and week 1 (post-surgery)

Interventions

GE CT 750 HDDIAGNOSTIC_TEST

Low-dose dual-energy CT imaging

Eligibility Criteria

Age5 Years - 20 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients with progression of scoliosis selected at the Rizzoli Orthopaedic Institute

You may qualify if:

  • patients with progression of scoliosis without vertebral arthrodesis
  • patients able to maintain immobility for the duration of the exam
  • patients from 5 to 20 years old

You may not qualify if:

  • pregnancy
  • vertebral arthrodesis
  • patients unable to maintain immobility for the duration of the exam
  • non-compliant patients
  • obese patients
  • patients younger than 5 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

MeSH Terms

Conditions

ScoliosisAnkylosis

Condition Hierarchy (Ancestors)

Spinal CurvaturesSpinal DiseasesBone DiseasesMusculoskeletal DiseasesJoint Diseases

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 30, 2018

Study Start

January 16, 2018

Primary Completion

December 31, 2019

Study Completion

December 31, 2019

Last Updated

September 26, 2023

Record last verified: 2023-09

Locations

IT(1)