Self-correction Evaluation in Scoliosis Patients

NCT05598021 | Recruiting

• 1 other identifier: Self-correction
• Study Type: observational
• Target: 185
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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

Eligibility Criteria

• Age: 10 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with adolescent and juvenile idiopathic scoliosis.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Istituto Scientifico Italiano Colonna Vertebrale: lead

Study Sites (1)

ISICO

Milan, Mi, 20141, Italy

RECRUITING

MeSH Terms

Conditions

Scoliosis

Condition Hierarchy (Ancestors)

Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Central Study Contacts

Stefano Negrini, MD

CONTACT

02 8416 1700; stefano.negrini@unimi.it

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2022
• First Posted: October 28, 2022
• Study Start: December 5, 2022
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: May 10, 2024

Record last verified: 2024-05

Locations

IT (1)