- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03483844
Low-dose Dual-energy CT for the Pre-surgical Planning of Patients With Progression of Scoliosis
Diagnostic Accuracy of Low-dose Dual-energy CT for the Pre-surgical Planning of Patients With Progression of Scoliosis
Study Overview
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 Type
Enrollment (Actual)
Contacts and Locations
Study Contact
- Name: Milva MD Battaglia, MD
- Phone Number: +390516366181
- Email: milva.battaglia@ior.it
Study Locations
-
-
-
Bologna, Italy, 40136
- Rizzoli Orthopaedic Institute
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Week 1 (post-surgery)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Radiation exposure
Time Frame: Baseline (pre-surgery) and week 1 (post-surgery)
|
Collection of dosimetric data
|
Baseline (pre-surgery) and week 1 (post-surgery)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Milva Battaglia, MD, Rizzoli Orthopaedic Institute
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- TCbd17
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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