An observational study in Idiopathic Scoliosis, Adolescent Idiopathic Scoliosis (AIS) and Juvenile Idiopathic Scoliosis, sponsored by Istituto Scientifico Italiano Colonna Vertebrale. Active, not recruiting at 1 site in Italy. Open to participants aged Up to 18 Years. Per ClinicalTrials.gov, last updated 2026-10-14.
Sponsored by Istituto Scientifico Italiano Colonna Vertebrale · Observational
This retrospective observational study aims to assess the real-world effectiveness of conservative treatment (bracing and specific exercises) in patients with idiopathic scoliosis treated with an Evidence-Based Personalised Approach (EBPA). Clinical records of about 30,000 patients collected in the institutional database of ISICO (Italian Scientific Spine Institute, Milan, Italy) since 2003 will be analysed. For each patient, the expected natural history (risk of progression without treatment) will be estimated with two validated prognostic models, IS-GROWTH and BrAIST-Calc. The outcome observed at skeletal maturity will be compared with the predicted risk to measure treatment effectiveness in preventing the 30°, 45° and 50° Cobb thresholds. Secondary aims include subgroup analyses by age at onset (infantile, juvenile, adolescent), validation of the prognostic models in the Italian population, over- and under-treatment rates, drop-outs and compliance, quality of life of patients and parents, and comparison between treatment tools.
Background. Idiopathic scoliosis is a three-dimensional deformity of the spine affecting 2-3% of the paediatric population, mainly during adolescence (adolescent idiopathic scoliosis, AIS). If not adequately treated during pubertal growth, the curve may progress beyond critical thresholds: 30° Cobb, below which the risk of chronic back pain and progression in adulthood is very low, and 45-50° Cobb, the surgical threshold.
The current evidence on bracing in AIS is based on the BrAIST randomised controlled trial, which showed that bracing prevents surgery. However, RCTs have intrinsic limits of generalisability: (1) strict inclusion criteria, since BrAIST included only about 2% of the real clinical population; (2) a single standardised treatment, while in clinical practice treatment is personalised according to patient response and shared decision making (EBPA); (3) a focus on AIS, leaving infantile and juvenile forms poorly studied.
This study will use validated prognostic models (IS-GROWTH and BrAIST-Calc) to build an individualised control population based on each patient's predicted risk of progression without treatment. Comparing the outcome observed at skeletal maturity with the predicted risk allows the effectiveness of treatment to be measured in a real-world setting on an unprecedented scale.
Design. Retrospective, observational, non-pharmacological, non-profit study based on data collected during routine clinical practice in the ISICO institutional clinical database, active since 2003. The study is a pragmatic benchmarking of clinical practice.
Data collected. Parameters recorded every 4-6 months during treatment will be extracted: radiographic data (Cobb angle, Risser stage, sagittal parameters: kyphosis and lordosis); clinical data (angle of trunk rotation, ATR; Trunk Aesthetic Clinical Evaluation, TRACE; weight; height); quality-of-life questionnaires (SRS-22, ISYQOL, SCaRES); treatment data (brace type: Sibilla, Lapadula, Sforzesco, PASB; prescribed and actual brace wear time, self-reported or measured with thermal sensors; Scientific Exercises Approach to Scoliosis, SEAS).
Definition of success. (1) Stability or improvement of the Cobb angle (change \< 5° or reduction ≥ 5°); (2) prevention of surgery, i.e. not reaching 45° (BrAIST-Calc) and 50° Cobb (IS-GROWTH); (3) low-risk target, i.e. end of growth with a curve \< 30° Cobb.
Statistical analysis. Analyses will be performed mainly with R: descriptive statistics (mean and standard deviation, or median and percentiles; frequencies with 95% confidence intervals); standardised incidence ratio (SIR) of observed versus expected cases according to natural history models, with 95% confidence intervals and Poisson statistics; relative risk (RR) and number needed to treat (NNT); intention-to-treat analysis, with drop-outs considered treatment failures; per-protocol analysis. Sample size is not predetermined: the whole eligible population will be analysed to maximise statistical power in subgroup analyses.
Ethics and data protection. The study is conducted in accordance with the Declaration of Helsinki. As a retrospective analysis of routinely collected data, it involves no additional risk for participants. Given the objective impossibility of contacting all patients, a waiver of informed consent is requested from the Ethics Committee, in accordance with GDPR articles 6, 9(2)(j) and 89, article 110 of the Italian Privacy Code and the Italian Data Protection Authority provision of 9 March 2023. A Data Protection Impact Assessment (DPIA) will be performed. Data will be pseudonymised and analysed only in aggregate form.
660 studies on the registry are indexed under Scoliosis; 186 are open to participants now.
This study's planned enrollment of 30,000 is above the median of 84 across 256 observational studies indexed under Scoliosis.
Browse Scoliosis studies →Istituto Scientifico Italiano Colonna Vertebrale is the lead sponsor of 13 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with infantile, juvenile or adolescent idiopathic scoliosis treated conservatively at ISICO (Italian Scientific Spine Institute) and recorded in the institutional clinical database between March 2003 and the date of data extraction (about 30,000 patients).
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Exclusion Criteria:
Patients with idiopathic scoliosis with onset at 0-3 years, treated conservatively
Device: Brace · Other: Specific exercises (SEAS)
Patients with idiopathic scoliosis with onset at 4-9 years, treated conservatively
Device: Brace · Other: Specific exercises (SEAS)
Patients with idiopathic scoliosis with onset at 10-18 years, treated conservatively
Device: Brace · Other: Specific exercises (SEAS)
Conservative treatment with a spinal brace (Sibilla, Lapadula, Sforzesco or PASB) prescribed during routine clinical practice, with personalised wear time. Prescribed and actual wear time (self-reported or measured with thermal sensors) are recorded. No intervention is assigned by the study.
Physiotherapeutic Scoliosis-Specific Exercises according to the Scientific Exercises Approach to Scoliosis (SEAS) protocol, prescribed during routine clinical practice. No intervention is assigned by the study.
Proportion of patients exceeding clinical severity thresholds (30°, 45° and 50° Cobb) at skeletal maturity, compared with predicted natural history
Observed proportion of patients reaching 30°, 45° and 50° Cobb at skeletal maturity, compared with the proportion expected from the IS-GROWTH (50°) and BrAIST-Calc (45°) prognostic models. Effectiveness is expressed as standardised incidence ratio (SIR) with 95% CI, relative risk (RR) and number needed to treat (NNT).
Time frame: From start of conservative treatment to skeletal maturity (Risser 4-5), assessed up to 18 years
Treatment effectiveness by age at onset
Percentage of patients reaching 30°, 45° and 50° Cobb at skeletal maturity, stratified by infantile (0-3 years), juvenile (4-9 years) and adolescent (10-18 years) idiopathic scoliosis.
Time frame: From start of conservative treatment to skeletal maturity (Risser 4-5), assessed up to 18 years
Predictive accuracy of IS-GROWTH and BrAIST-Calc
Discrimination of each prognostic model in the Italian population, expressed as area under the ROC curve (AUC) for predicting curve progression to 50° (IS-GROWTH) and 45° Cobb (BrAIST-Calc).
Time frame: From start of conservative treatment to skeletal maturity (Risser 4-5), assessed up to 18 years
Rate of over-treatment and under-treatment
Proportion of patients treated despite low predicted risk and of patients not adequately treated despite high predicted risk.
Time frame: From start of conservative treatment to skeletal maturity (Risser 4-5), assessed up to 18 years
Cobb angle stability or improvement
Proportion of patients with stable (change \< 5°) or improved (reduction ≥ 5°) Cobb angle at end of treatment compared with baseline.
Time frame: From start of conservative treatment to skeletal maturity (Risser 4-5), assessed up to 18 years
Drop-out rate and reasons
Percentage of patients abandoning treatment before skeletal maturity; reasons for drop-out are reported descriptively.
Time frame: From start of conservative treatment to skeletal maturity (Risser 4-5), assessed up to 18 years
Brace compliance
Actual brace wear time in hours per day (self-reported or measured with thermal sensors), compared with prescribed wear time.
Time frame: From start of conservative treatment to skeletal maturity (Risser 4-5), assessed up to 18 years
Determinants of treatment outcome
Odds ratios of baseline clinical and treatment variables associated with treatment success, estimated with multivariable predictive models.
Time frame: From start of conservative treatment to skeletal maturity (Risser 4-5), assessed up to 18 years
Patient quality of life
Change from baseline in Scoliosis Research Society-22 (SRS-22) total score. Score range 1-5; higher scores indicate better quality of life. Change from baseline in Italian Spine Youth Quality of Life (ISYQOL) score. Score range \[0-100\]; higher scores indicate better quality of life.
Time frame: From start of conservative treatment to skeletal maturity (Risser 4-5), assessed up to 18 years
Parent-reported quality of life
Change from baseline in Scoliosis Caregiver Response and Emotional Scale (SCaRES) score. Score range \[0-100\]; higher scores indicate \[better/worse\] outcome.
Time frame: From start of conservative treatment to skeletal maturity (Risser 4-5), assessed up to 18 years
Comparison between treatment tools
Outcome of comparable patient groups treated with different braces (Sibilla, Lapadula, Sforzesco, PASB) and exercises.
Time frame: From start of conservative treatment to skeletal maturity (Risser 4-5), assessed up to 18 years
Plan to share: No
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Istituto Scientifico Italiano Colonna Vertebrale