Self-correction Evaluation in Scoliosis Patients

NCT ID: NCT05598021

Last Updated: 2024-05-10

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 185 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-12-05
• Study Completion Date: 2025-12-31

Brief 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).

Conditions

Scoliosis; Juvenile; Scoliosis; Adolescence

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: RETROSPECTIVE

Study Groups

Ultrasound assessment

Quantitative comparison between ultrasound images performed in active self-correction and in a spontaneous position

No interventions assigned to this group

RX assessment

Quantitative comparison between radiological images performed in active self-correction and in a spontaneous position

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• 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

• Minimum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istituto Scientifico Italiano Colonna Vertebrale

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

ISICO

Milan, Mi, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Stefano Negrini, MD

Role: CONTACT

stefano.negrini@unimi.it

02 8416 1700

Facility Contacts

Stefano Negrini, MD

Role: primary

stefano.negrini@isico.it

0039 02 84161700

Other Identifiers

Self-correction

Identifier Type: -

Identifier Source: org_study_id