Self-correction Evaluation in Scoliosis Patients

Instrumental Evaluation of Self-correction in Patients With Juvenile and Adolescent

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).

Study Overview

• Status: Recruiting
• Conditions: Scoliosis; Juvenile; Scoliosis; Adolescence

• Study Type: Observational
• Enrollment (Estimated): 185

Contacts and Locations

• Study Contact: Name: Stefano Negrini, MD; Phone Number: 02 8416 1700; Email: stefano.negrini@unimi.it

Study Locations

• Italy
  • Mi
    • Milan, Mi, Italy, 20141
      • Recruiting
      • ISICO
      • Contact: Stefano Negrini, MD; Phone Number: 0039 02 84161700; Email: stefano.negrini@isico.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with adolescent and juvenile idiopathic scoliosis.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Ultrasound assessment; Quantitative comparison between ultrasound images performed in active self-correction and in a spontaneous position
RX assessment; Quantitative comparison between radiological images performed in active self-correction and in a spontaneous position

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Istituto Scientifico Italiano Colonna Vertebrale

Study record dates

Study Major Dates

• Study Start (Actual): December 5, 2022
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: October 21, 2022
• First Submitted That Met QC Criteria: October 25, 2022
• First Posted (Actual): October 28, 2022

Study Record Updates

• Last Update Posted (Actual): May 10, 2024
• Last Update Submitted That Met QC Criteria: May 9, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spinal Curvatures; Scoliosis
• Other Study ID Numbers: Self-correction

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No