Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03483844
Recruitment Status : Recruiting
First Posted : March 30, 2018
Last Update Posted : January 16, 2019
Sponsor:
Information provided by (Responsible Party):
Milva Battaglia, 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

Condition or disease Intervention/treatment
Scoliosis Diagnostic Test: GE CT 750 HD

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.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Diagnostic Accuracy of Low-dose Dual-energy CT for the Pre-surgical Planning of Patients With Progression of Scoliosis
Actual Study Start Date : January 16, 2018
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scoliosis


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


Primary Outcome Measures :
  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 Outcome Measures :
  1. Radiation exposure [ Time Frame: Baseline (pre-surgery) and week 1 (post-surgery) ]
    Collection of dosimetric data



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   5 Years to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with progression of scoliosis selected at the Rizzoli Orthopaedic Institute
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03483844


Contacts
Layout table for location contacts
Contact: Milva MD Battaglia, MD +390516366181 milva.battaglia@ior.it

Locations
Layout table for location information
Italy
Rizzoli Orthopaedic Institute Recruiting
Bologna, Italy, 40136
Contact: Tiziana Greggi, MD    +390516366430    tiziana.greggi@ior.it   
Sponsors and Collaborators
Istituto Ortopedico Rizzoli
Investigators
Layout table for investigator information
Principal Investigator: Milva Battaglia, MD Rizzoli Orthopaedic Institute

Layout table for additonal information
Responsible Party: Milva Battaglia, Principal Investigator, Istituto Ortopedico Rizzoli
ClinicalTrials.gov Identifier: NCT03483844    
Other Study ID Numbers: TCbd17
First Posted: March 30, 2018    Key Record Dates
Last Update Posted: January 16, 2019
Last Verified: January 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Milva Battaglia, Istituto Ortopedico Rizzoli:
scoliosis
low dose
arthrodesis
dual-energy CT
Additional relevant MeSH terms:
Layout table for MeSH terms
Scoliosis
Spinal Curvatures
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases