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NCT Number: NCT03483844

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

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

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Key information

Conditions

Scoliosis Ankylosis Bone Diseases Joint Diseases Musculoskeletal Diseases Spinal Curvatures Spinal Diseases

Age range

5 year–20 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Rizzoli Orthopaedic Institute

Bologna, 40136, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GE CT 750 HD

Diagnostic Test

Low-dose dual-energy CT imaging

Primary outcomes

  1. Diagnostic accuracy

    Time frame: 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 outcomes

  1. Radiation exposure

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

    Collection of dosimetric data

Sponsors and collaborators

Lead sponsor

Istituto Ortopedico Rizzoli

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Mar 30, 2018
Registry last updated
Sep 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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