ClinicalTrials.gg
CompletedNCT03483844Updated Sep 26, 2023

Low-dose Dual-energy CT for the Pre-surgical Planning of Patients With Progression of Scoliosis

An observational study in Scoliosis, sponsored by Istituto Ortopedico Rizzoli. Completed at 1 site in Italy. Open to participants aged 5 Years to 20 Years. Per ClinicalTrials.gov, last updated 2023-09-26.

Sponsored by Istituto Ortopedico Rizzoli · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
64
Ages
5 Years to 20 Years
Sex
All
01

Study 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

Read the detailed description

CT imaging is the gold standard for assessing bone dysmorphism and vertebral morphometry during the pre-surgical planning of vertebral arthrodesis. It is necessary in the definition of the fixation points to avoid malposition of transpedicular screws and potential visceral, vascular or neurological damage.

It is known that multislice CT involves an increased radiation exposure for patients, while dual-energy CT uses a low-dose acquisition protocol and VEO reconstruction software.

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 who are candidated for vertebral arthrodesis.

02

Conditions studied

  • Scoliosis

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Keywords

  • scoliosis
  • low dose
  • arthrodesis
  • dual-energy CT
03

In context

Scoliosis

660 studies on the registry are indexed under Scoliosis; 186 are open to participants now.

This study's enrollment of 64 is below the median of 84 across 256 observational studies indexed under Scoliosis.

Browse Scoliosis studies →

Lead sponsor

Istituto Ortopedico Rizzoli is the lead sponsor of 304 studies on the registry; 103 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
5 Years to 20 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with progression of scoliosis selected at the Rizzoli Orthopaedic Institute

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
64 participants (actual)
Patient registry
No

Interventions

  • Diagnostic testGE CT 750 HD

    Low-dose dual-energy CT imaging

06

What researchers measure

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.

    Time frame: Week 1 (post-surgery)

Secondary outcomes

  1. Radiation exposure

    Collection of dosimetric data

    Time frame: Baseline (pre-surgery) and week 1 (post-surgery)

07

Study locations

1 site
  • Rizzoli Orthopaedic Institute
    Bologna, 40136, Italy
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jan 2018 to primary completion in Dec 2019, 23 months.

Of 94 non-industry observational studies under Scoliosis, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 99. This study's 23 months is below that.

Counting every sponsor, half of 106 studies reached it within 36 months; a quarter within 9 and three quarters within 92.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 7, 2018
First posted
Mar 30, 2018
StartActual
Jan 16, 2018
Primary completionActual
Dec 31, 2019
CompletionActual
Dec 31, 2019
Last update
Sep 26, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 26, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03483844
Responsible party
Sponsor
First posted
Mar 30, 2018
Start date
Jan 16, 2018
Primary completion
Dec 31, 2019
Completion
Dec 31, 2019
Last update
Sep 26, 2023

Study contacts

Milva Battaglia, MD
principal investigator · Rizzoli Orthopaedic Institute

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.

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