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

Completed

• Conditions: Scoliosis

• Registration Number: NCT03483844
• Lead Sponsor: Istituto Ortopedico Rizzoli

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.

Study Timeline

• Study Start: 2018-01-16
• Study First Submitted: 2018-03-07
• Study First Submitted QC: 2018-03-29
• Study First Posted: 2018-03-30
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-22
• Last Update Posted: 2023-09-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Radiation exposure	Baseline (pre-surgery) and week 1 (post-surgery)	Collection of dosimetric data

Trial Locations

Locations (1)

Rizzoli Orthopaedic Institute; 🇮🇹 Bologna, Italy