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NCT05912140 Clinical Trial

Assessment of Trunk Aesthetics: Development of a New Tool

Adolescent Idiopathic Scoliosis Clinical Trial

— TRACE2  

Official title:
TRACE2: Development of a New Tool for the Evaluation of the Trunk Aesthetics in Patients With Scoliosis

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT05912140
Other study ID # TRACE2
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date June 6, 2023
Est. completion date September 2024

Study information
Verified date June 2023
Source Istituto Scientifico Italiano Colonna Vertebrale
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 600
Est. completion date September 2024
Est. primary completion date June 2024
Accepts healthy volunteers
Gender All
Age group 10 Years to 17 Years
Eligibility Inclusion Criteria: - diagnosis of scoliosis - age between 10 and 17 years old - scoliosis >10° Cobb - humps > 5° ATR Exclusion Criteria: - History of spinal surgery - positive neurological assessment

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• TRACE 2
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).

Locations
Country Name City State
Italy ISICO Milan Mi

Sponsors (1)
Lead Sponsor Collaborator
Istituto Scientifico Italiano Colonna Vertebrale

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary TRACE2 New version of the TRACE tool for the assessment of trunk aesthetics in patients with scoliosis through study completion, an average of 1 year
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