Assessment of Trunk Aesthetics: Development of a New Tool

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Adolescent Idiopathic Scoliosis

Age range

10 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

ISICO

Milan, Mi, 20141, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TRACE 2

Other

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).

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

Istituto Scientifico Italiano Colonna Vertebrale

Other

Registry information

Official study title

TRACE2: Development of a New Tool for the Evaluation of the Trunk Aesthetics in Patients with Scoliosis

Acronym: TRACE2

Important dates

Study start: 2023
Primary completion: 2025
Study completion: 2025
First posted: Jun 22, 2023
Registry last updated: Oct 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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