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

NCT ID: NCT03483844

Last Updated: 2023-09-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

64 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-16

Study Completion Date

2019-12-31

Brief Summary

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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

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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.

Conditions

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Scoliosis

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Interventions

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GE CT 750 HD

Low-dose dual-energy CT imaging

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

5 Years

Maximum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Istituto Ortopedico Rizzoli

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Milva Battaglia, MD

Role: PRINCIPAL_INVESTIGATOR

Rizzoli Orthopaedic Institute

Locations

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Rizzoli Orthopaedic Institute

Bologna, , Italy

Site Status

Countries

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Italy

Other Identifiers

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TCbd17

Identifier Type: -

Identifier Source: org_study_id

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