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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05598021
Other study ID # Self-correction
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date December 5, 2022
Est. completion date December 2025

Study information

Verified date May 2024
Source Istituto Scientifico Italiano Colonna Vertebrale
Contact Stefano Negrini, MD
Phone 02 8416 1700
Email stefano.negrini@unimi.it
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

To date, there is no objective assessment method for the quality of the self-correction performed by patients with scoliosis. The study consists of two parts, both retrospective, and distinct on the basis of the tools used to assess self-correction. Part 1: Retrospective assessment of the radiographic variations between spontaneous position and self-correction in subjects suffering from juvenile and adolescent idiopathic scoliosis. Both measurements were performed in a single session. Part 2: Retrospective assessment of the variations between spontaneous and self-correcting position in subjects with juvenile and adolescent idiopathic scoliosis using objective parameters deriving from non-invasive 3D ultrasound instrumentation (Scolioscan, Telefeld, Hong Kong).


Recruitment information / eligibility

Status Recruiting
Enrollment 185
Est. completion date December 2025
Est. primary completion date December 2025
Accepts healthy volunteers No
Gender All
Age group 10 Years and older
Eligibility Inclusion Criteria for both parts: - Diagnosis of juvenile or adolescent idiopathic scoliosis; - Age >= 10 years; - Single and double curves with amplitude >= 15 ° Cobb; - Performing exercises according to SEAS for at least 6 months Only for part 1 (radiographic) - Availability of radiographic investigation in upright position and in self-correction Only for part 2 (ultrasound) - Availability of ultrasound assessment in upright position and in self-correction - Complete radiograph of the spine in anteroposterior projection performed in the 45 days preceding or following the medical examination. - Risser between 0 and 2. Exclusion Criteria: For both parts: - Patients with more than 2 scoliotic curves - Patients with secondary scoliosis - Patients suffering from learning disabilities or clinical conditions impairing neuromotor control - Patients lacking the necessary measures to evaluate the outcome. Part 2 only (ultrasound) ? Patients undergoing brace treatment

Study Design


Related Conditions & MeSH terms


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 Self-correction measure The angular difference of the curves resulting from the detection with Scolioscan or Rx in the spontaneous position compared to what was obtained in the same condition but in the self-correcting position. through study completion, an average of 6 months
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