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Assessment of Trunk Aesthetics: Development of a New Tool

Study acronym: TRACE2
StatusActive, Not Recruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated October 3, 2024 (before its estimated June 2025 completion). Its status may not reflect the trial's current state.

Record History

  1. Primary completion date: Jun 2024 to Jun 2025
    • Study completion date: Sep 2024 to Sep 2025
    v2
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05912140
Lead Sponsor Istituto Scientifico Italiano Colonna Vertebrale
Conditions
(from sponsor)		 Adolescent Idiopathic Scoliosis
Enrollment 600 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov