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Self-correction Evaluation in Scoliosis Patients

I

Istituto Scientifico Italiano Colonna Vertebrale

Status

Enrolling

Conditions

Scoliosis; Adolescence
Scoliosis; Juvenile

Study type

Observational

Funder types

Other

Identifiers

NCT05598021
Self-correction

Details and patient eligibility

About

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).

Enrollment

185 estimated patients

Sex

All

Ages

10+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

185 participants in 2 patient groups

Ultrasound assessment
Description:
Quantitative comparison between ultrasound images performed in active self-correction and in a spontaneous position
RX assessment
Description:
Quantitative comparison between radiological images performed in active self-correction and in a spontaneous position

Trial contacts and locations

1

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Central trial contact

Stefano Negrini, MD

Data sourced from clinicaltrials.gov

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