Idiopathic ScoliosisNCT03464318
Low-dose Digital Radiographs in the Idiopathic Scoliosis
An observational study of Idiopathic Scoliosis, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
Trial summary
The aim of the study is to evaluate the intraobserver repeatability and the interobserver reproducibility of low-dose radiographs with a HELIOS DRF (CAT) imaging system in patients with idiopathic scoliosis. Read more about this study
- Who is it for?
- Ages 9 to 20 years
- Conditions the study is for
- Idiopathic Scoliosis
- How many people
- 105 participants
- Where
- 1 siteItaly
- Study dates
- 27 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 9 to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: patients with suspected or known idiopathic scoliosis selected at the Rizzoli Orthopaedic Institute
Who may be able to join
- patients with suspected or known idiopathic scoliosis
- patients able to maintain orthostasis without medical devices
- patients from 9 to 20 years old
Who cannot join
- patients with known congenital, syndromic, neurological scoliosis
- patients not able to maintain orthostasis
- obese patients
- low back pain or known tumor pathology
- patients with vertebral arthrodesis
- patients younger than 9 years old, or older than 20 years old
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Repeatability and Reproducibility of Low-dose Digital Radiographs in the Idiopathic Scoliosis
The aim of the study is to evaluate the intraobserver repeatability and the interobserver reproducibility of low-dose radiographs with a HELIOS DRF (CAT) imaging system in patients with idiopathic scoliosis.
Read the detailed description
The 80% of scoliosis is idiopathic and begins mostly in adolescence (10-20 years).
The young patients need to undergo several radiographic controls for a correct therapeutic balance. However, the repeated radiation exposures is associated with a greater risk of carcinogenesis even if reduced with a digital imaging technique.
The aim of this study is to evaluate the intraobserver repeatability and the interobserver reproducibility of low-dose radiographs with a HELIOS DRF (CAT) imaging system in patients with idiopathic scoliosis.
- Conditions
- Idiopathic Scoliosis
- Keywords
- idiopathic scoliosis, radiographs, low dose
What is being measured
The primary outcome is the main question the study is designed to answer.
Repeatability and reproducibility
Repeatability and reproducibility of the Cobb angle measurement
Measured: baseline (day 0)
Secondary outcomes (2)
Repeatability and reproducibility
Repeatability and reproducibility of kyphosis angle, lordosis angle, lumbosacral angle, Nash-Moe rotation index and Risser index measurement
Measured: baseline (day 0)
Radiation exposure
collection of dosimetric data
Measured: baseline (day 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2018
- Study start27 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 Idiopathic 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
- 105 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
- NCT03464318
- Sponsor's protocol ID
- RXbd17
- 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
- Repeatability and Reproducibility of Low-dose Digital Radiographs in the Idiopathic Scoliosis
- ClinicalTrials.gov ID
- NCT03464318
- Acronym / sponsor ID
- RXbd17
- Conditions
- Idiopathic Scoliosis
- Keywords
- idiopathic scoliosis, radiographs, low dose
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Istituto Ortopedico RizzoliUniversity, hospital or other
- Study start
- 27 Jan 2018 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 14 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 intraobserver repeatability and the interobserver reproducibility of low-dose radiographs with a HELIOS DRF (CAT) imaging system in patients with idiopathic scoliosis.
Detailed description
The 80% of scoliosis is idiopathic and begins mostly in adolescence (10-20 years).
The young patients need to undergo several radiographic controls for a correct therapeutic balance. However, the repeated radiation exposures is associated with a greater risk of carcinogenesis even if reduced with a digital imaging technique.
The aim of this study is to evaluate the intraobserver repeatability and the interobserver reproducibility of low-dose radiographs with a HELIOS DRF (CAT) imaging system in patients with idiopathic scoliosis.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 9 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- patients with suspected or known idiopathic scoliosis selected at the Rizzoli Orthopaedic Institute
Key inclusion criteria (3 listed)
- patients with suspected or known idiopathic scoliosis
- patients able to maintain orthostasis without medical devices
- patients from 9 to 20 years old
Key exclusion criteria (6 listed)
- patients with known congenital, syndromic, neurological scoliosis
- patients not able to maintain orthostasis
- obese patients
- low back pain or known tumor pathology
- patients with vertebral arthrodesis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Repeatability and reproducibility
Time frame: baseline (day 0)
Repeatability and reproducibility of the Cobb angle measurement
2 secondary outcomes
Repeatability and reproducibility
Time frame: baseline (day 0)
Radiation exposure
Time frame: baseline (day 0)
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 Idiopathic 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?
Repeatability and reproducibility (time frame: baseline (day 0)). 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.