Adolescence Idiopathic Scoliosis

Adolescent idiopathic scoliosis (AIS) is a three-dimensional spinal deformity, and a subset of patients undergo surgical correction during adolescence, most commonly posterior spinal fusion (PSF). Although surgical treatment improves deformity and quality of life in the short and mid-term, its long-term impact on functional status in adulthood remains insufficiently understood. This cross-sectional study aims to evaluate long-term outcomes in adults aged 25-40 years who underwent surgical treatment for AIS, compared with non-operated individuals with scoliosis and healthy controls. The study will assess limitations in daily functioning, musculoskeletal and respiratory function, pain, and compensatory mechanisms using standardized clinical measurements and questionnaires. The findings are expected to provide insight into long-term functional consequences of AIS and support the development of targeted physiotherapy and preventive strategies for adults treated for scoliosis during adolescence.

Background and Problem Overview Adolescent Idiopathic Scoliosis (AIS) is a progressive musculoskeletal disorder characterized by a three-dimensional deformation of the spine occurring during adolescence. Diagnosis is typically established with a Cobb angle exceeding 10° and the presence of axial rotation. While the exact etiology remains unknown, leading theories include tissue abnormalities (muscle fibers, bone volume), impaired spinal biomechanics (asymmetric bone growth), and neurological factors (asymmetric cortical thickness, cerebral lateralization, and body schema distortions). The progressive nature of AIS, particularly the high risk of advancement at the onset of puberty, complicates clinical decision-making. Treatment is traditionally divided into three stages: Observation and Exercise: For Cobb angles between 10°-25°. Exercise and Bracing: For Cobb angles between 25°-45°. Surgery: For Cobb angles exceeding 45°. Despite these guidelines, the unpredictable progression of the disease and difficulties in treatment adherence create significant dilemmas. Specifically, for cases on the borderline of surgical indication, clinicians face the challenge of choosing between immediate surgery or conservative monitoring. Currently, there is no definitive method to predict progression, and patients are typically monitored in 6-month intervals. During these intervals, a patient's condition may remain stable or deteriorate significantly. Furthermore, guidelines recommend wearing a brace for an average of 18 hours per day, often for several years. This requirement is physically and psychologically demanding for adolescents, leading to poor compliance due to aesthetic concerns, functional limitations, and skin irritation. The inability to predict progression often leads to overtreatment (unnecessary bracing) or undertreatment (delayed intervention), both of which pose risks to the patient's long-term health. Radiological Concerns Disease progression is monitored via direct radiography (X-rays). However, frequent imaging increases the lifetime risk of cancer due to cumulative ionizing radiation. Notably, the risk of breast cancer in girls with AIS is reported to be approximately seven times higher than in the healthy population. Conversely, extending follow-up intervals risks missing windows for early intervention. An artificial intelligence (AI) model capable of predicting curve progression could optimize imaging frequency, ensuring safety while maintaining clinical efficacy. Objective and Methodology of the Study The primary aim of this research is to develop a machine learning-based model to predict the Cobb angle following a 12-week exercise intervention. The model will utilize comprehensive baseline and post-treatment data, including: Demographic and Anthropometric Data (Age, height, weight, gender). Clinical Assessments (Cobb angle, Risser score, angle of trunk rotation). Functional and Physical Metrics (Trunk muscle strength, Maximal Inspiratory and Expiratory Pressure \[MIP/MEP\], Biodex balance measurements). Visual Assessments (Walter Reed Visual Deformity Scale \[WRVAS\]). Research Hypotheses Primary Hypothesis: A machine learning model trained on pre- and post-exercise assessment data can significantly predict the Cobb angle at the end of a 12-week period with both statistical and clinical accuracy. Secondary Hypothesis: By predicting the risk of progression (the probability of an increase in Cobb angle), this model will contribute to reducing unnecessary surgical interventions, overtreatment (bracing/surgery), and cumulative X-ray exposure.

SUMMARY Rationale: Delayed union is a problem in adolescent idiopathic scoliosis (AIS) surgery, especially at the distal end of the construct. Surgeons therefore use local autograft or bone graft substitutes to prevent loss of correction and/or anchor failure and additionally restrict patients' activities during the first year. The concept of this study was developed after the promising results of the MaxA study (METC 18-311), where we compared the efficacy of BCP\<μm ceramic granules (MagnetOs™ Granules) to autograft in posterolateral fusion (PLF). This randomized intra-patient-controlled trial indicated superior spinal fusion rates for the BCP\<μm condition. The current investigational product (MagnetOs™ Putty) is made of the same MagnetOs™ Granules embedded in a fast-resorbing polymeric binder to improve surgical handling. If MagnetOs™ Putty allows better and faster fusion in scoliosis patients, it is possible to mobilize them faster and even abandon post-operative activity restrictions. Objective: The primary objective is to demonstrate superiority and safety of MagnetOs™ Putty compared to autograft regarding the posterolateral spinal fusion rate, in instrumented PLF in AIS patients. The secondary objectives encompass comparisons of posterolateral spinal fusion rates on different levels at various points in time, monitoring the changes in trunk rotation, evaluating quality of life and patient's experiences as well as improving the reliability of Hounsfield unit measurements. Study design: Multicenter, randomized, controlled superiority trial with intra-patient comparisons over a 1-year follow-up. Study population: 140 patients between 12 to 30 years with AIS qualified for scoliosis surgery with lowest instrumented vertebrae T12-L4. Intervention: According to a randomization scheme, one side of the caudal PLF will be grafted with the MagnetOs™ Putty and the other side with local bone. The rest of the surgical procedure will be according to standard care. Main study parameters/endpoints: The fusion rate of MagnetOs™ Putty compared to standard fusion with local autograft, assessed locally and centrally through a three plane assessment tool at the caudal segment on CT scans at 3 or 6 months. The complication rate will be compared to the rate in control populations from literature. Nature and extent of the burden and risks associated with participation, benefit, and group relatedness: The study population includes AIS patients between 12 to 30 years with an indication for PLF. Patient burden and risks are expected to be minimal. The post-operative follow-up will be according to standard care. Additional study procedures include the completion of patient-reported outcome measures (PROM) at four time points and a limited CT scan. Based on pre-clinical investigations and the results of the MaxA study, we expect MagnetOs™ Putty to perform better than the current treatment. This may benefit the patient as currently about 5% experience problems of delayed union in our own series.

This prospective randomized controlled trial will evaluate whether adding resisted inspiratory muscle training (IMT) to Physiotherapeutic Scoliosis-Specific Exercises (PSSE)-Schroth exercises provides additional benefits on clinical outcomes in individuals with adolescent idiopathic scoliosis. Participants will be randomly assigned to either PSSE-Schroth plus IMT or PSSE-Schroth alone. Both groups will receive supervised exercise sessions three times per week for 8 weeks (24 sessions). Outcomes will be assessed before and after the intervention and will include clinical measures (e.g., Cobb angle, angle of trunk rotation, Posterior Trunk Symmetry Index, The Walter Reed Visual Assessment Scale), respiratory muscle performance (maximal inspiratory pressure/maximal expiratory pressure, six-minute walk test) and related physiological parameters, functional performance (balance, 3D kinematics, plantar pressure analysis, isokinetic strength), sleep quality, and health-related quality of life (Scoliosis Research Society- 22, Italian Spine Youth Quality of Life). The study is expected to enroll approximately 45 participants.

Adolescent idiopathic scoliosis (AIS) is a spinal condition that develops during adolescence and often requires long-term conservative treatment, including scoliosis-specific therapeutic exercises. The success of exercise-based treatment largely depends on adolescents' motivation to start and continue exercising. However, exercise motivation has not been adequately evaluated in adolescents with idiopathic scoliosis using validated tools specific to this population. The Behavioral Regulation in Exercise Questionnaire-2 (BREQ-2) is a widely used questionnaire based on Self-Determination Theory that assesses different types of motivation toward exercise. Although the Turkish version of the BREQ-2 exists, its validity and reliability have not yet been examined in adolescents with idiopathic scoliosis. The purpose of this study is to evaluate the validity and reliability of the Turkish version of the BREQ-2 in adolescents diagnosed with idiopathic scoliosis. Adolescents aged 10-19 years who have been participating in scoliosis-specific therapeutic exercise programs for at least two months will be invited to complete online questionnaires. The results of this study will help determine whether the BREQ-2 is an appropriate tool for assessing exercise motivation in this population and may support the development of individualized motivational strategies in scoliosis rehabilitation.

This study aims to compare the effectiveness of core stabilization exercises versus traditional rehabilitation exercises in adolescents with idiopathic scoliosis. Participants are assigned to one of two intervention groups: a core stabilization exercise program or a traditional rehabilitation program. The study evaluates the impact of both interventions on spinal stability, posture, and functional outcomes. The results of this study may help identify more effective rehabilitation approaches for managing adolescent idiopathic scoliosis.