Low-dose Dual-energy CT for the Pre-surgical Planning of... | NCT03483844

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

NCT03483844

Sponsor

Istituto Ortopedico Rizzoli

Status

Completed

Last Update Posted

Sep 26, 2023Actual

Enrollment

64Actual

Phase

Not provided

Conditions

Scoliosis

Interventions

GE CT 750 HD

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 16, 2018Actual

Primary Completion Date

Dec 31, 2019Actual

Completion Date

Dec 31, 2019Actual

First Submitted Date

Mar 7, 2018

First Submission Date that Met QC Criteria

Mar 29, 2018

First Posted Date

Mar 30, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 22, 2023

Last Update Posted Date

Sep 26, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

64Actual

Name	Type	Description	Arm Group Labels	Other Names
GE CT 750 HD	Diagnostic Test	Low-dose dual-energy CT imaging

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Diagnostic accuracy	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 Outcomes

Measure	Description	Time Frame
Radiation exposure	Collection of dosimetric data	Baseline (pre-surgery) and week 1 (post-surgery)

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

5 Years

Maximum Age

20 Years

Standard Ages

ChildAdult

Study Population

Patients with progression of scoliosis selected at the Rizzoli Orthopaedic Institute

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Milva Battaglia, MD	Rizzoli Orthopaedic Institute	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rizzoli Orthopaedic Institute		Bologna		40136	Italy

Condition Browse Module

MeSH Terms

ID	Term
D012600	Scoliosis
D000844	Ankylosis

Ancestor Terms

ID	Term
D013121	Spinal Curvatures
D013122	Spinal Diseases
D001847	Bone Diseases
D009140	Musculoskeletal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided