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Active, not recruitingNCT06408896PREPAREUpdated May 10, 2024

Development and Internal Validation of Predicting Models of Idiopathic Scoliosis Natural History and Treatment Outcomes Through the Use of Artificial Intelligence in a Large Clinical Database

An observational study in Scoliosis Idiopathic, sponsored by Istituto Scientifico Italiano Colonna Vertebrale. Active, not recruiting at 1 site in Italy. Open to participants aged Up to 20 Years. Per ClinicalTrials.gov, last updated 2024-05-10.

Sponsored by Istituto Scientifico Italiano Colonna Vertebrale · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
9,651
Ages
Up to 20 Years
Sex
All
01

Study summary

Scoliosis is a three-dimensional deformity of the spine. In its most common form (about 70% of cases), the causes are unknown, therefore it is called idiopathic scoliosis. In most cases, it is discovered after 10 years of age, and is defined diagnostically as a curve of at least 10°, measured on a standing x-ray using the Cobb method.

If scoliosis exceeds the critical threshold of 30° Cobb at the end of growth, there is a progressively greater risk of health and social problems in adult life. For this reason, the main aim of the treatment is to complete the growth period with a curve less than 30° and good sagittal balance, or at least well below 50°, which represents the surgical threshold.

Growth is a factor favouring the evolution of deformities, therefore patients are followed until the end of growth. This is why therapy can last many years, from the discovery of the presence of a deformity until bone maturation is achieved.

The early identification of parameters predictive of the outcome of the therapy to direct the least possible aggressiveness towards the result necessary for the patient's future, integrated with the evaluation of its effectiveness (monitoring), is one of the most important objectives in this field to minimize the burden of treatment in a particular phase of growth such as adolescent development, as well as to identify the subjects most at risk of worsening in adulthood.

The systematic collection of clinical data during the therapeutic process offers the possibility, through advanced analysis models, applied retrospectively, to identify predisposing factors and protective factors. When the data available is sufficiently large, it is possible to obtain predictive equations that assist clinicians in therapeutic choices and help patients understand the risks and benefits of available therapies. New technologies such as artificial intelligence techniques offer new and interesting ways of estimating risks and calculating the benefits and safety of some therapeutic choices compared to others.

This study aims to develop and internally validate data-driven stratification and prediction models to predict multiple end-of-care outcome measures that include curve magnitude, measured in Cobb degrees, measures determining the sagittal balance, and measures of quality of life and function measured through self-completion questionnaires.

02

Conditions studied

  • Scoliosis Idiopathic

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03

In context

Scoliosis

594 studies on the registry are indexed under Scoliosis; 139 are open to participants now.

This study's planned enrollment of 9,651 is above the median of 89 across 233 observational studies indexed under Scoliosis.

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Lead sponsor

Istituto Scientifico Italiano Colonna Vertebrale is the lead sponsor of 12 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Up to 20 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Growing subjects, aged 20 years or younger, with scoliosis curves greater than 10 degrees measured according to the Cobb method, provided with radiographic and clinical data, who have accessed the facility specialized in the treatment of scoliosis since its foundation in March 2003 and who continued the treatment until reaching maturity of bone development (at least grade 3 of Risser's sign).

Inclusion criteria

  • diagnosis of idiopathic scoliosis
  • \< 20 year old

Exclusion criteria

Exclusion Criteria:

  • Secondary scoliosis
  • history of scoliosis corrective surgery
  • history of pathologies affecting the spine that can affect the result or spine trauma
  • Iatrogenic scoliosis
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
9,651 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. End growth below 30 degrees Cobb

    The primary outcome measures are binary and include thresholds correlated with risks in adult life: end growth below 30 degrees Cobb (indicating a healthy spine, not exposed to risks of evolution in adult life) and end growth above 50 degrees Cobb (or final surgical treatment decision).

    Time frame: through study completion, an average of 5 year

  2. growth above 50 degrees Cobb

    The primary outcome measures are binary and include thresholds correlated with risks in adult life: end growth below 30 degrees Cobb (indicating a healthy spine, not exposed to risks of evolution in adult life) and end growth above 50 degrees Cobb (or final surgical treatment decision).

    Time frame: through study completion, an average of 5 year

07

Study locations

1 site
  • ISICO
    Milan, Mi 20141, Italy
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 10, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06408896
Lead sponsor
Istituto Scientifico Italiano Colonna Vertebrale
Responsible party
Sponsor
First posted
May 10, 2024
Start date
Apr 24, 2024
Primary completion
Dec 2029 (estimated)
Completion
Dec 2029 (estimated)
Last update
May 10, 2024

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in May 2024. You cannot join it, but the record below documents what was studied.

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