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NCT03483844 Clinical Trial

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

Scoliosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03483844
Other study ID # TCbd17
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 16, 2018
Est. completion date December 31, 2019

Study information
Verified date September 2023
Source Istituto Ortopedico Rizzoli
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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

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.

Recruitment information / eligibility
Status Completed
Enrollment 64
Est. completion date December 31, 2019
Est. primary completion date December 31, 2019
Accepts healthy volunteers No
Gender All
Age group 5 Years to 20 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• GE CT 750 HD
Low-dose dual-energy CT imaging

Locations
Country Name City State
Italy Rizzoli Orthopaedic Institute Bologna

Sponsors (1)
Lead Sponsor Collaborator
Istituto Ortopedico Rizzoli

Country where clinical trial is conducted

Italy, 

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