ScoliosisNCT03483844
Low-dose Dual-energy CT for the Pre-surgical Planning of Patients With Progression of Scoliosis
An observational study of Scoliosis, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
Trial 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 Read more about this study
- Who is it for?
- Ages 5 to 20 years
- Conditions the study is for
- Scoliosis
- What is being tested?
- GE CT 750 HD
- How many people
- 64 participants
- Where
- 1 siteItaly
- Study dates
- 16 Jan 2018to 31 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients with progression of scoliosis selected at the Rizzoli Orthopaedic Institute
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Diagnostic Accuracy of 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
Read the 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.
- Conditions
- Scoliosis
- Being tested
- GE CT 750 HD
- Keywords
- scoliosis, low dose, arthrodesis, dual-energy CT
- Medical subject headings
- Scoliosis, Ankylosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GE CT 750 HDDiagnostic test
Low-dose dual-energy CT imaging
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy
To evaluate the percentage of malpositioning of transpedicular screw. A percentage of malpositioning lower than 10% will be considered as acceptable.
Measured: Week 1 (post-surgery)
Secondary outcomes (1)
Radiation exposure
Collection of dosimetric data
Measured: Baseline (pre-surgery) and week 1 (post-surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2018
- Study start16 Jan 2018
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ScoliosisStudies of the same condition, open and under way.
- More trials run by Istituto Ortopedico RizzoliThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Ortopedico Rizzoli
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Milva Battaglia, MD, Principal investigator, Rizzoli Orthopaedic Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03483844
- Sponsor's protocol ID
- TCbd17
- Status last verified
- Sep 2023
- First submitted
- 7 Mar 2018
- Last updated
- 26 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Accuracy of Low-dose Dual-energy CT for the Pre-surgical Planning of Patients With Progression of Scoliosis
- ClinicalTrials.gov ID
- NCT03483844
- Acronym / sponsor ID
- TCbd17
- Conditions
- Scoliosis
- Keywords
- scoliosis, low dose, arthrodesis, dual-energy CT
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Istituto Ortopedico RizzoliUniversity, hospital or other
- Study start
- 16 Jan 2018 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 30 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 5 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients with progression of scoliosis selected at the Rizzoli Orthopaedic Institute
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- pregnancy
- vertebral arthrodesis
- patients unable to maintain immobility for the duration of the exam
- non-compliant patients
- obese patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GE CT 750 HDLow-dose dual-energy CT imaging | Diagnostic test | – |
Primary outcome
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.
1 secondary outcome
Radiation exposure
Time frame: Baseline (pre-surgery) and week 1 (post-surgery)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Milva Battaglia, MD principal investigator
Rizzoli Orthopaedic Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Scoliosis, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy (time frame: Week 1 (post-surgery)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2023.