Clinical Research Directory

Real-World Effectiveness of Conservative Treatment in Idiopathic Scoliosis

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.

Development of a Conservative Care and Bracing Registry (CCBR)

Idiopathic scoliosis (IS) is a common problem affecting approximately 3% of the population; its progression can lead to significant health problems. The BrAIST study proved brace effectiveness, which increased bracing interest and utilization globally. There is a lack of evidence-based guidelines for brace treatment. There is significant variability in the brace literature with little consistency in indications for brace treatment goals, brace types, use of monitors, timing of radiographs, and evaluation of skeletal maturity. This lack of evidence demonstrates a clear need for a multi-center brace registry. The first aim of this proposal is to develop a comprehensive retrospective brace registry. This project involves expert clinicians, researchers and an orthotist, each with broad clinical and research experience in the field of bracing for scoliosis. The retrospective registry will function as a pilot, providing strategies to optimize variables, streamline data collection and minimize missing data. The next step will be to develop and launch a multicenter, prospective brace registry and Quality Improvement registry.

Impact of Spinal Curves on Asymmetric Posture in Idiopathic Scoliosis

Asymmetric postures are often observed in patients with adolescent idiopathic scoliosis (AIS) and are partially associated with instability in sitting and standing positions, as well as with imbalances in gait kinematic parameters in cases of moderate or severe scoliosis. Based on the currently available data, no correlation has been identified between habitual postures in daily life and the presence of scoliosis. However, the asymmetry of preferred postures in relation to the morphological characteristics of the curves, and how this might contribute to the progression of the clinical condition due to prolonged uneven load distribution, has not yet been analyzed. Understanding any preferential direction in postures habitually adopted by patients with idiopathic scoliosis could provide valuable insights for the conservative management of the condition. The aim of this study is to analyze the influence of the morphological characteristics of scoliotic curves (type and laterality) in patients with juvenile and adolescent idiopathic scoliosis on the choice of preferentially maintained asymmetric postures in daily life, using a descriptive questionnaire completed by family members and caregivers, compared to a group of non-scoliotic subjects. Evaluate the effect of curve magnitude, age, sex, and Risser grade on the choice of usual asymmetric postures. Estimate the impact of prolonged maintenance of habitual asymmetric postures on the clinical progression in patients with juvenile and adolescent idiopathic scoliosis