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
|Condition or disease||Intervention/treatment|
|Scoliosis||Diagnostic Test: GE CT 750 HD|
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 :||Observational|
|Estimated Enrollment :||30 participants|
|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|
- Diagnostic Test: GE CT 750 HD
Low-dose dual-energy CT imaging
- 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.
- Radiation exposure [ Time Frame: Baseline (pre-surgery) and week 1 (post-surgery) ]Collection of dosimetric data
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
|Contact: Milva MD Battaglia, MDfirstname.lastname@example.org|
|Rizzoli Orthopaedic Institute||Recruiting|
|Bologna, Italy, 40136|
|Contact: Tiziana Greggi, MD +390516366430 email@example.com|
|Principal Investigator:||Milva Battaglia, MD||Rizzoli Orthopaedic Institute|