Assessment of Trunk Aesthetics: Development of a New Tool

NCT05912140 | Active Not Recruiting

• 1 other identifier: TRACE2
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Adolescent Idiopathic Scoliosis

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Trunk Aesthetic Clinical Evaluation

Other: TRACE 2

Interventions

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).

Trunk Aesthetic Clinical Evaluation

Eligibility Criteria

• Age: 10 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Adolescent with a diagnosis of scoliosis

You may qualify if:

• diagnosis of scoliosis
• age between 10 and 17 years old
• scoliosis \>10° Cobb
• humps \> 5° ATR

You may not qualify if:

• History of spinal surgery
• positive neurological assessment

Sponsors & Collaborators

• Istituto Scientifico Italiano Colonna Vertebrale: lead

Study Sites (1)

ISICO

Milan, Mi, 20141, Italy

Location

Study Officials

• Stefano Negrini, MD, Phd

  Istituto Scientifico Italiano Colonna Vertebrale

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2023
• First Posted: June 22, 2023
• Study Start: June 6, 2023
• Primary Completion: June 1, 2025
• Study Completion: September 1, 2025
• Last Updated: October 3, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share

Locations

IT (1)