Clinical Research Directory

A Randomized Intra-Patient Controlled Trial of MagnetOs™ Putty vs Autograft in Instrumented Posterolateral Spinal Fusion in Idiopathic Scoliosis Patients

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.

Resisted Inspiratory Muscle Training Applied in Addition to PSSE-Schroth Exercises

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.

The Effects of Lumbopelvic Rhythm on Postural Control, Daily Activities, and Quality of Life in Individuals With AIS

Adolescent idiopathic scoliosis (AIS) leads to three-dimensional spinal deformity during adolescence, causing deviations in the frontal, sagittal, and axial planes, impairing physical function, balance, and lumbopelvic rhythm. Individuals with AIS exhibit decreased trunk movement, muscle overactivation, increased energy expenditure, balance/gait disturbances, and abnormalities in proprioceptive/vestibular input; pressure center deviations increase in postural control. These changes negatively impact daily life, pain, and quality of life. Although the literature has examined the relationships between AIS and muscle activation, range of motion, pelvic position, and gait/balance, the relationship between lumbopelvic rhythm changes and curve type/localization/severity, and its impact on postural control and quality of life, has not been investigated. This study aims to elucidate movement patterns by evaluating lumbopelvic rhythm in individuals with AIS and to guide clinical diagnosis/treatment.

Validity and Reliability of the Behavioral Regulation in Exercise Questionnaire-2 (BREQ-2) in Adolescents With Idiopathic Scoliosis

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.

Effect of Core Stabilization Exercises Versus Traditional Rehabilitation in Adolescent With Idiopathic Scoliosis

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.

Acute Training Effect Assessment in Adolescent Idiopathic Scoliosis

This study aims to assess the immediate effects of a self-corrective exercise on muscle activity and spinal alignment in adolescents with idiopathic scoliosis. Eligible participants will undergo clinical assessments of spine deviation and surface electromyography (EMG) before and after a single session of guided self-controled and self-corrective exercise. The findings may help inform rehabilitation strategies for adolescent idiopathic scoliosis.