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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03483844

Enrollment

Registered

2018-03-30

Start date

2018-01-16

Completion date

2019-12-31

Last updated

2023-09-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Scoliosis

Keywords

scoliosis, low dose, arthrodesis, dual-energy CT

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

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.

Interventions

DIAGNOSTIC_TESTGE CT 750 HD

Low-dose dual-energy CT imaging

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

5 Years to 20 Years

Healthy volunteers

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

* 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

Design outcomes

Primary

Measure	Time frame	Description
Diagnostic accuracy	Week 1 (post-surgery)	To evaluate the percentage of malpositioning of transpedicular screw. A percentage of malpositioning lower than 10% will be considered as acceptable.

Secondary

Measure	Time frame	Description
Radiation exposure	Baseline (pre-surgery) and week 1 (post-surgery)	Collection of dosimetric data

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026