Clinical Research Directory

Brace Monitoring for Adolescent Idiopathic Scoliosis (AIS)

The overall aim of the study is to utilize a novel device and smartphone application in order to improve measurement of patient compliance with at-home bracing for scoliosis as well as create a more accurate assessment of brace fit via continuous and objective measures of tension. These ground-breaking metrics will provide analyzable data to more accurately reflect and predict actual patient compliance as well as allow for further exploration of how to increase compliance, and thus, efficacy of bracing; it will additionally allow both physicians and patients to have a more reliable measure for brace fit by providing them with continuous data of fit via tension, and provide built-in feedback mechanisms to the patient to ensure proper tightness of the brace. Additionally, the study will investigate whether providing the wearer's own brace-wear compliance information directly to the patient and their caregiver(s) via the mobile app will further improve rates of compliance as compared to those who do not receive the same feedback mechanism.

Diaphragm Mobilization in Adolescent Idiopathic Scoliosis

Adolescent idiopathic scoliosis (AIS) is a three-dimensional spinal deformity that can affect posture, trunk movement, and respiratory function. Changes in the shape of the rib cage may influence diaphragm function and breathing mechanics in individuals with scoliosis. The Schroth Best Practice (SBP) exercise program is commonly used in the conservative treatment of scoliosis and focuses on posture correction and scoliosis-specific exercises. However, the additional benefits of manual diaphragm mobilization combined with this exercise program are not well known. The aim of this randomized controlled trial is to investigate the effect of diaphragm mobilization added to the Schroth Best Practice program in adolescents with idiopathic scoliosis. Participants will be randomly assigned to two groups: one group will perform the SBP exercise program alone, and the other group will receive SBP exercises combined with diaphragm mobilization. The intervention will be performed three times per week for six weeks. Assessments will be conducted at baseline, at the end of the 6-week intervention, and at a 12-week follow-up. Outcomes will include respiratory function measured by spirometry, trunk rotation, thoracic mobility, trunk flexibility, quality of life, and body image. The results of this study may help determine whether adding diaphragm mobilization to scoliosis-specific exercise programs improves clinical outcomes in adolescents with idiopathic scoliosis.

Advanced SPinal Innovations With Robotics and Enabling Technology Registry

Creation of a pediatric robotic spine surgery registry will allow for data collection and analysis on the coupled use of robotics and navigation, as well as patient-specific rods in pediatric spine deformity surgery across participating study institutions. Eventually, an educational and informative framework for this technology will be established.

3D, Dynamic and Mechanically-informed Decision Making in AIS

Adolescent Idiopathic Scoliosis (AIS) is a growth defect of the spine that primarily occurs in prepubertal children between the age of 10 to 14 years, affecting approximately 3% of these otherwise normal children. AIS has been associated with problems related to posture, load-related back pain, as well as aesthetic problems, e.g. the induced asymmetry of the shoulder. Therefore, early diagnosis followed by the appropriate treatment is vital to prevent further curve progression of AIS and minimize the health-related complications of these patients. The current treatment recommendation to stop curve progression for an immature patient with a scoliosis curve between 25 and 40 degrees is to wear a brace. If the curve in the skeletally immature patient is not responding to the brace treatment, dynamic scoliosis correction by vertebral body tethering can be considered when there is still some growth potential left. State-of-the-art guidelines for the selection of fusion levels are currently mainly based on two-dimensional (2D) static radiographic parameters (such as, the Cobb angle and Shoulder balance) and a qualitative assessment of 2D bending or traction radiographs. Several classification systems and algorithms that are based on the 2D static radiographic (X-ray) parameters exist to assist surgeons in determining the appropriate levels to be instrumented. Despite this wide range of classification systems and detailed guidelines available in the literature, spinal fusion does not always yield satisfying 2D radiographic clinical outcome, with revision rates ranging from 3.9% to 22%. Overall, the surgeon is presently not provided with 3D dynamic and mechanical information regarding the deformity of the AIS to guide the decision-making. Obtaining this vital 3D dynamic information regarding the curvature and mechanical behavior of the spine will allow the surgeon to make an evidence-based and well-informed decisions in the treatment of the AIS patient. Consequently, realizing these objectives has the potential to improve patient satisfaction, reduce the postoperative complications and accordingly reduce socio-economic costs associated with AIS treatment. Recent advances in the use of subject specific musculoskeletal models will form the basis to realize this shift from 2D to 3D dynamic in AIS care.

Spine Surgery for Lenke 1 Adolescent Idiopathic Scoliosis

Idiopathic scoliosis of developmental age (AIS) is the most vertebral deformity in the adolescent population, with a prevalence of 1-3%. The treatment of AIS depends on the morphology and extent of the curve and the growth potential residual, can range from simple clinical-radiological monitoring, to the use of braces to, in the most severe cases, correction surgical correction. The indication for surgical correction of AIS depends on the location, extent and flexibility of the scoliotic curve and not least on the patient's age or, better, the skeletal age. The primary goal of surgery is to correcting the deformity by preventing its progression, preserving as many motion segments as possible; secondarily, the surgery aims to restore the coronal and sagittal balance of the spine.

Low Dose Dexmedetomidine as a Postoperative Pain Adjunct

This randomized controlled trial examines whether the addition of a low-dose dexmedetomidine infusion to our current multimodal pain management plan decreases narcotic consumption and reduces side effects in adolescent patients undergoing posterior spinal fusion for idiopathic scoliosis.

Dysport ® as an Adjunctive Treatment to Bracing in the Management of Adolescent Idiopathic Scoliosis

This study evaluates the combined effect of botulinum toxin A (administered as Dysport® (Ipsen Pharmaceuticals)) and bracing in children with adolescent idiopathic scoliosis. Two thirds of patients will be treated with Dysport® and bracing, while the remaining patients will be treated with placebo and bracing.

Hypermobility, Foot Posture, and Scoliosis Severity

Adolescent Idiopathic Scoliosis is a three-dimensional spinal deformity that may also affect joint mobility, lower limb alignment, and overall posture. Joint hypermobility and foot posture abnormalities, including pronation or supination, are commonly observed in adolescents and may contribute to postural imbalance or altered biomechanical loading. However, the relationship between hypermobility, foot posture, and the severity of scoliosis remains unclear. The aim of this study is to examine whether generalized joint hypermobility and foot posture characteristics are associated with Cobb angle severity in adolescents diagnosed with Adolescent Idiopathic Scoliosis. Hypermobility will be assessed using the Beighton Score, and foot posture will be evaluated with the Foot Posture Index. Understanding these associations may help clinicians better evaluate biomechanical factors related to scoliosis and guide future preventive or therapeutic approaches.

Active Video Game-Based Exercise Training and Stability Training After AIS Surgery

The purpose of this clinical trial is to investigate the effects of "Active Video-Based Exercises (AVTE) on postural control and balance in comparison with stabilization exercises is (AIS) after Posterior Spinal Fusion (PSF) surgery. Fifty-one patients with AIS after PSF surgery will be randomly divided into groups as Group I-AVTE Group, Group II-Exercise Group, Group III-Control Group, and a 12-week program will be applied. Evaluations will be performed at baseline, 12 and 24 weeks. The primary evaluations will be postural stability and balance; secondary evaluations will be pain, trunk muscle strength, mobility, endurance, core stabilization, function, quality of life, and satisfaction.

Scapula and Upper Extremity Performance in Scoliosis

Adolescent Idiopathic Scoliosis s a three-dimensional spinal deformity that may alter shoulder girdle alignment, scapular orientation, and upper extremity biomechanics. Changes in scapular position can influence arm movement, muscle activation, and overall functional performance. Understanding these relationships is clinically important for developing effective exercise and rehabilitation strategies. The aim of this study is to examine the association between scapular position and upper extremity performance in adolescents diagnosed with Adolescent Idiopathic Scoliosis. Scapular dyskinesis, scapular lateral displacement, and upper limb functional performance will be evaluated and correlated with Cobb angle severity. Findings may help clinicians better understand functional impairments linked to scoliosis and support more targeted rehabilitation programs.

MRI-Guided Dynamic Support System for Scoliosis Correction

This prospective pilot study evaluates the feasibility and effectiveness of an MRI-guided dynamic support system (MRI-DSS) for rapid, quantitative correction of adolescent idiopathic scoliosis (AIS). The system uses MRI-compatible air padding supports and programmable pneumatic control to apply and adjust corrective forces in real time. AIS patients underwent MRI-guided bracing, with Cobb angles and biomechanical parameters measured at each pressure level.

Post-approval Registry Study to Evaluate the Continued Safety and Probable Benefit of the MID-C System for 5 Years Post-Implantation in Adolescent Idiopathic Scoliosis (AIS)

The ApiFix MID-C System is a unidirectional expandable rod, designed to be connected unilaterally to the spine via 2 anchor points on the concave side of a scoliotic deformity above and below the apex of the major curvature to treat adolescent idiopathic scoliosis. The MID-C System is designed to act as an internal brace. Patients implanted with the device in the US within 2 years of FDA's approval of H17001 should be enrolled in the study. A minimum number of 200 patients will be enrolled in this study.

Interest of Adapted Physical Activity by Tele-rehabilitation in Chronic Pathology - Idiopathic Scoliosis in Adolescents

This study is a randomised controlled trial designed to compare two adapted physical activity treatments for adolescent idiopathic scoliosis (AIS). The main hypotheses it aims to address are as follows: * Treatment with a HIIT (High-Intensity Interval Training) type training program via tele-rehabilitation, supervised by an adapted physical activity teacher, is effective in AIS. * A 12-week physical activity program maintains this efficacy over the long term. To test this hypothesis, Two groups of adolescents will be evaluated: a first group made up of non-athletic adolescents suffering from Idiopathic Scoliosis who will benefit from a tele-rehabilitation (physical activity sessions at home supervised by a teacher in adapted physical activities by video). A second group, control, also made up of non-athletic adolescents suffering from Idiopathic Scoliosis who will benefit from a self-program at home consisting of exercises specific to their scoliosis.

Assessment of Respiratory Parameters, Aerobic Capacity and Sleep Quality in Thoracic AIS

This study aims to compare respiratory parameters -including pulmonary function and respiratory muscle strength-as well as aerobic capacity and sleep quality in individuals with thoracic adolescent idiopathic scoliosis. Participants will be categorized according to the ISST classification into T-type and TL-type curvature patterns. The study will evaluate differences between these groups using standardized clinical assessments.

Kids With Iron Deficiency and Scoliosis

This study is a randomized controlled trial of preoperative oral iron supplementation, to identify whether iron deficiency is a modifiable risk factor for adverse surgical outcomes such as red blood cell transfusion and diminished postoperative cognitive and physical capacity in adolescents undergoing scoliosis surgery. Research Question(s)/Hypothesis(es): Primary * Iron supplementation will reduce the incidence of perioperative RBC transfusion in iron deficient scoliosis patients undergoing spinal fusion. Secondary * Iron supplementation will reduce postoperative neurocognitive functional declines in iron deficient scoliosis patients undergoing spinal fusion. * Iron supplementation will improve patient-reported physical functioning in iron deficient scoliosis patients undergoing spinal fusion.

Schroth and Pilates Exercises in Idiopathic Adolescent Scoliosis

Adolescent idiopathic scoliosis (AIS) is a common anomaly that is frequently seen in prepubertal growth and is characterized by deviation and rotation of the spine, causing high level of disability. Pubertal development and asymmetrical load distribution increase the progression of the deformity. Affecting the spinal structure and its movement can affect the structures and cause problems in many areas such as pain, balance, respiration, mental health and quality of life. AIS can cause functional disability by causing deterioration in chest wall mechanics, weakness in respiratory muscles and limitation of functional capacity. As the disease progresses, prolonged hypoinflation and atelectasis lead to irreversible atrophy of the lungs and further reduction in lung volume. Displacement and/or compression of the heart due to thoracic deformity may not allow for the required increase in stroke volume during exercise. In severe cases, patients are at risk of developing pulmonary hypertension due to chronic respiratory failure and chronic atelectasis, chronic hypoxemia, chronic hypercapnia. In addition, muscle atrophy and muscle weakness in AIS are thought to cause muscle imbalances and loss of balance. Exercise is the most appropriate treatment for low and moderate AIS cases due to its low cost and low risk of complications. Exercises prevent the development of many problems by controlling the severity of curvature and preventing the progression of curvature. It is thought that scoliosis exercises can delay or even prevent surgery and reduce the duration or degree of brace, especially in patients with low-to-moderate curvature during growth. One of these exercise approaches, the Schroth technique, is primarily based on isometric muscle contraction exercises that aim to rotate, lengthen and stabilize the spine. The core component of the Schroth method is autocorrection, defined as the patient's ability to reduce spinal deformity through active postural realignment of the spine in three dimensions. Another frequently used exercise method, Pilates exercise training improves flexibility and overall physical health by emphasizing the coordination of movements associated with strength, posture, and breathing. However, the effects of these exercises in reducing curvature and related problems are controversial in the literature. Therefore, in this study, we aimed to investigate the effects of Schroth and pilates exercises on respiratory functions, functional capacity, balance, spine structure and quality of life in adolescents with idiopathic scoliosis. Thirty patients aged 10 to 18 years, with a Cobb angle between 10 and 25 degrees, will be included in the study. The subjects will be randomly divided into two groups; Schroth exercises will be applied to one group and pilates exercises will be applied to another group. All participants will participate in exercise sessions of 60 minutes a day, 3 days a week, for 8 weeks. Each participant will receive a total of 24 sessions of exercise therapy under the supervision of a physiotherapist. In this study, exercises that activate the muscle groups responsible for maintaining the correct posture and correcting the curvature will be selected for practice. Within the study, axial trunk rotation with a scoliometer, respiratory functions and respiratory muscle strength measurement with spirometry, functional capacity with the 6-minute walking test, balance with the Tecnobody balance measuring device, quality of life with Scoliosis will be assessed by the Research Society-22 Quality of Life Questionnaire. The results obtained from the study are of great importance as they will help to determine the effects of Schroth and pilates exercises on spinal deformity and the treatment of related problems in patients with AIS and to establish appropriate programs for the prevention and treatment of these problems.

Minimally Invasive Surgery vs Standard Posterior Approach in the Treatment of Developmental Idiopathic Scoliosis

This is a randomized trial with 1:1 allocation. The aim of the study is to evaluate clinical and radiographic outcomes in patients with developmental age idiopathic scoliosis treated with mini invasive scoliosis surgery (MIS) technique versus posterior spinal fusion (PSF) technique through clinical and radiographic evaluations.

Preoperative Carbohydrate Drink in Adolescent Idiopathic Scoliosis Surgery: the Impact on Safety and Enhanced Recovery

The goal of this interventional study is to learn if carbohydrates loading improves overall outcome in adolescent patient undergoing scoliosis curgery The main questions of the study are as follows: 1. Does carbohydrates loading improves gastrointestinal related problems such as improvement in return of bowel function measured by first passage of flatus, reduce constipation by patient's time to first bowel opening and reduce incidence of post post operative nausea and vommiting 2. Does carbohydrates loading reduces length of hospital stay and patient's overall condition in term of anxiety, thirst and hunger 3. Does carbohydrates loading affects gastric residual volume by measuring residual gastric volume with ultrasound

3D Body Surface Modeling for Scoliosis Monitoring

This is a single center, prospective, non-randomized reproducibility study of the NSite device in patients undergoing evaluation for scoliosis. The NSite device is a pre-market, investigational device. The study will enroll 13 eligible patients, who will be scanned using the NSite device by 3 separate users in order to assess if the device generates similar results across users. This data will be used to support 510(k) submission.

Postoperative Steroid Use in Adolescent Idiopathic Scoliosis and Neuromuscular Scoliosis Patients

The goal of this randomized clinical trial is to compare the immediate use of steroids after surgery for accelerated discharge in adolescent idiopathic scoliosis and neuromuscular scoliosis after a posterior spinal fusion. The main question it aims to answer are: * What are the effects of using steroids immediately after surgery in decreasing opioid use and helping early mobilization(movement)? * Does post-operative steroid use affect the incidence of wound complications and are there any long-term impacts on scar formation? Participants will: * Fill out a Patient-Reported Outcomes Measurement Information System (PROMIS) survey specifically for pain interference and physical activity observing health related quality of life at enrollment, 3 months, 1 year, and 2 years * Have clinical photos of their incision at 3 months, 1 year, and 2 years * Their photos will be assessed using the stony book scar evaluation scale * For treatment of their scoliosis, patients will undergo a posterior spinal fusion (PSF) per standard of care, however whether the participant receives or does not receive steroids is what the investigators are trying to understand. * Researchers will compare no immediate postoperative steroid (NS) to the group with immediate postoperative steroid (WS) group to see if there are changes in opioid use, wound complications, scar formation, and facilitation in early mobilization.

Detecting and Monitoring Scoliosis Without Radiography: Standard Radiographic Monitoring Program Versus Self-Screening with Momentum SpineTM

The goal of this clinical trial is for the Momentum SpineTM application to accurately detect scoliosis progression, including accuracy, margin of error, sensitivity, specificity, AUC, and overall agreement with radiographs in 8-18 year olds with adolescent idiopathic scoliosis. The main question it aims to answer \[is/are\]: * Based on previous data it is hypothesize that Momentum SpineTM imaging software will be able to accurately detect scoliosis progression (\>= 7 degrees), including accuracy, margin of error, sensitivity, specificity, AUC, and overall agreement with radiographs. * Based on the above hypothesis that Momentum SpineTM is able to accurately detect scoliosis and curve progression (\>= 7 degrees). * It is hypothesized there will be indications for accelerated clinical visits based on at home detection of progression, and that these visits will be accurate and necessary. * It is hypothesized that there will be a proportion of standard care visits that are deemed unnecessary, and that the application is able to accurately predict these visits. Participants will: * Use Momentum SpineTM assessment from home to perform body scans at 1-month intervals on personal device and during the clinical visit. * Received monthly scans that will be evaluated by the provider using the application. * Receive additional scans as warranted. * Complete net promoter score (NPS) within the application following completion of a body scan. * Complete a patient satisfaction survey following 6 months of application usage.

Identification of Circulating microRNAs in Adolescent Idiopathic Scoliosis

The aim of the present study is to evaluate the expression of a large panel of microRNAs, already known and validated in other ortopedic pathologies and bone metabolism, in the plasma of Adolescent Idiopathic Scoliosis (AIS) patients. The deregulated microRNAs identified will be then validated and computational analyzes will determine their potential involvement in the metabolism of bone and/or cartilage tissue in order to correlate the results obtained with the clinical data of the AIS patients. The investigators aimed to develop a microRNAs panel to further validate in a larger population of AIS patients in order to produce a device for the diagnosis and prognosis of Molecular-based AIS.

Central Motor Mechanisms in AIS Via HD-sEMG, EEG and Neuromuscular Coupling Analysis

1. Verifying the Motor Control Effects of Spinal Manipulation on AIS Using outpatient and inpatient AIS patients from our department as the study subjects, standardized spinal manipulation treatment is applied. The efficacy is evaluated through a combination of clinical outcome measures, HD-EMG for paraspinal muscle function assessment, and Pro-Kin balance system for trunk stability analysis. This establishes an AIS efficacy platform to further clarify the effectiveness of spinal manipulation in motor control regulation of AIS. 2. Investigating the Central Motor Network's Response to Spinal Manipulation in AIS Utilizing high-density sEMG-EEG technology, synchronized brain and muscle electrical signals are collected before and after treatment. By employing a neuromuscular synchronization and coupling analysis approach that integrates linear and nonlinear methods, the characteristic indices of information interaction between the central system and muscles are identified. This further explores the motor control and response characteristics of the muscle-cortex network to spinal manipulation in AIS.

Effect of a Postural Re-education Intervention Compared to Standard Care on Scoliosis Progression in Adolescent

The aim of this project is to verify the effect of the global postural reeducation (GPR) intervention used in physiotherapy on scoliosis progression (scoliosis angle), back pain, quality of life, respiratory function, trunk posture and trunk muscle functioning and walking endurance. To do so, we will recruit 144 participants at three scoliosis specialized Centers. Participants will be randomly allocated to the standard of care (SC) group (observation or brace plus home video of exercises for 12 months) or to the GPR group (SC plus individual sessions once a week for 6 months and individual sessions alternating with telerehabilitation sessions once per two weeks between 6 and 12 months). At initial, 6, 12- and 24-months evaluation, participants will have x-ray, complete self-report questionnaires to document back pain and quality of life. Thereafter, measurement of trunk posture, electromyography activity of the back muscles, excursion of the diaphragm muscle using echography and respiratory function as well as distance covered using the 6-minute walk test for walking endurance will be done. We believe that GPR intervention may prevent scoliosis progression and improve physical health and quality of life in adolescence.