Adolescent Idiopathic ScoliosisTRACE2NCT05912140
Assessment of Trunk Aesthetics: Development of a New Tool
An observational study of Adolescent Idiopathic Scoliosis, run by Istituto Scientifico Italiano Colonna Vertebrale at 1 site in Italy.
Trial summary
Scoliosis is a three-dimensional deformity of the spine and the trunk. TRACE (Trunk Aesthetic Clinical Evaluation) is an aesthetics assessment tool for patients with scoliosis. It has been validated with Rasch analysis is easily usable in daily clinical practice. Read more about this study
- Who is it for?
- Ages 10 to 17 years
- Conditions the study is for
- Adolescent Idiopathic Scoliosis
- What is being tested?
- TRACE 2
- How many people
- 600 participants
- Where
- 1 siteItaly
- Study dates
- 6 Jun 2023to Sep 2025
- 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 10 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Adolescent with a diagnosis of scoliosis
Who may be able to join
- diagnosis of scoliosis
- age between 10 and 17 years old
- scoliosis >10° Cobb
- humps > 5° ATR
Who cannot join
- History of spinal surgery
- positive neurological assessment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: TRACE2: Development of a New Tool for the Evaluation of the Trunk Aesthetics in Patients with Scoliosis
Scoliosis is a three-dimensional deformity of the spine and the trunk. TRACE (Trunk Aesthetic Clinical Evaluation) is an aesthetics assessment tool for patients with scoliosis. It has been validated with Rasch analysis is easily usable in daily clinical practice. Despite this tool being more sensitive in detecting changes in aesthetics during treatment compared to other existing ones, its reliability is still low, probably due to the small number of elements that make up the rating scale.
This study aims to develop a new version of the TRACE tool by adding new items. The development of TRACE2 in a Rasch environment will ensure greater sensitivity and specificity of the scale assessment.
- Conditions
- Adolescent Idiopathic Scoliosis
- Being tested
- TRACE 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TRACE 2Other
The first version of TRACE2 will be retrospectively verified through its application by experts on 150 photos of scoliosis patients who agreed to use the material produced for clinical use for retrospective research. Both intra-operator and inter-operator repeatability will be evaluated and a first Rasch analysis will be performed.
The new version of TRACE2 (TRACE2.2) obtained following the retrospective validation on the photos will be verified prospectively through its application by the experts on 150 patients in specialist medical examination. Both intra-operator and inter-operator repeatability will be evaluated and further Rasch analysis will follow. On the basis of the results obtained from the analysis, the new TRACE2 scale (TRACE2.3) will then be applied to a further 150 patients, its intra- and inter-operator repeatability will be calculated and a final Rasch analysis will be performed to arrive at the final version of the scale (TRACE2.4).
| Study group | Role | What they receive |
|---|---|---|
| Trunk Aesthetic Clinical Evaluation | Not described Receives: Other: TRACE 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
TRACE2
New version of the TRACE tool for the assessment of trunk aesthetics in patients with scoliosis
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2023
- Study start6 Jun 2023
- Primary completionJun 2025 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adolescent Idiopathic ScoliosisStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Scientifico Italiano Colonna Vertebrale
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stefano Negrini, MD, Phd, Principal investigator, Istituto Scientifico Italiano Colonna Vertebrale
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05912140
- Sponsor's protocol ID
- TRACE2
- Acronym
- TRACE2
- Status last verified
- Oct 2024
- First submitted
- 12 Jun 2023
- Last updated
- 3 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymous data will be deposited on an online repository
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TRACE2: Development of a New Tool for the Evaluation of the Trunk Aesthetics in Patients with Scoliosis
- ClinicalTrials.gov ID
- NCT05912140
- Acronym / sponsor ID
- TRACE2 / TRACE2
- Conditions
- Adolescent Idiopathic Scoliosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Istituto Scientifico Italiano Colonna VertebraleUniversity, hospital or other
- Study start
- 6 Jun 2023 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 22 Jun 2023 (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.
Scoliosis is a three-dimensional deformity of the spine and the trunk. TRACE (Trunk Aesthetic Clinical Evaluation) is an aesthetics assessment tool for patients with scoliosis. It has been validated with Rasch analysis is easily usable in daily clinical practice. Despite this tool being more sensitive in detecting changes in aesthetics during treatment compared to other existing ones, its reliability is still low, probably due to the small number of elements that make up the rating scale.
This study aims to develop a new version of the TRACE tool by adding new items. The development of TRACE2 in a Rasch environment will ensure greater sensitivity and specificity of the scale assessment.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Trunk Aesthetic Clinical Evaluation | – | Other: TRACE 2 |
Who may qualify
- Ages
- 10 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Adolescent with a diagnosis of scoliosis
Key inclusion criteria (4 listed)
- diagnosis of scoliosis
- age between 10 and 17 years old
- scoliosis >10° Cobb
- humps > 5° ATR
Key exclusion criteria (2 listed)
- History of spinal surgery
- positive neurological assessment
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 |
|---|---|---|
| TRACE 2The first version of TRACE2 will be retrospectively verified through its application by experts on 150 photos of scoliosis patients who agreed to use the material produced for clinical use for retrospective research. Both intra-operator and inter-operator repeatability will be evaluated and a first Rasch analysis will be performed. The new version of TRACE2 (TRACE2.2) obtained following the retrospective validation on the photos will be verified prospectively through its application by the experts on 150 patients in specialist medical examination. Both intra-operator and inter-operator repeatability will be evaluated and further Rasch analysis will follow. On the basis of the results obtained from the analysis, the new TRACE2 scale (TRACE2.3) will then be applied to a further 150 patients, its intra- and inter-operator repeatability will be calculated and a final Rasch analysis will be performed to arrive at the final version of the scale (TRACE2.4). | Other | Trunk Aesthetic Clinical Evaluation |
Primary outcome
TRACE2
Time frame: through study completion, an average of 1 year
New version of the TRACE tool for the assessment of trunk aesthetics in patients with scoliosis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2024.
- Individual participant dataSharing planned: Yes. Anonymous data will be deposited on an online repository
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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.
Stefano Negrini, MD, Phd principal investigator
Istituto Scientifico Italiano Colonna Vertebrale
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 Adolescent Idiopathic Scoliosis, run by Istituto Scientifico Italiano Colonna Vertebrale 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 4 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 3 Oct 2024. 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?
Results are not available in the source record.
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?
TRACE2 (time frame: through study completion, an average of 1 year). 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 3 Oct 2024.