Clinical Research Directory

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.

The Effect of Peloidotherapy in Young Adults Undergoing Physical Therapy Scoliosis Specific Exercises (PSSE)

Scoliosis is a musculoskeletal disorder defined by a three-dimensional spinal deformity that can result in substantial clinical and functional limitations, particularly during adolescence and young adulthood. Affected individuals commonly experience postural asymmetry, muscular imbalance, pain, and diminished quality of life. In conservative management, Physiotherapeutic Scoliosis-Specific Exercises (PSSE) have gained recognition as a fundamental intervention. The primary objectives of PSSE include optimizing spinal alignment, facilitating rotational breathing, and restoring muscular symmetry to improve functional capacity. Evidence from systematic reviews suggests that PSSE, especially the Schroth method, are superior to general exercise programs in improving both radiographic parameters and health-related quality of life.Meta-analytic findings further support the effectiveness of PSSE in reducing curve magnitude and enhancing quality of life outcomes. Among the various PSSE approaches, the Schroth method is one of the most extensively investigated and widely applied in clinical settings. This method incorporates three-dimensional postural correction, targeted breathing techniques, and the development of postural awareness. Randomized controlled trials have demonstrated that Schroth exercises significantly improve SRS-22 quality of life scores and positively influence pain, body image, and overall well-being.Despite these established benefits, pain and muscle tension occurring during exercise sessions may negatively influence adherence to rehabilitation programs. In young adults, pain is a critical factor limiting treatment compliance and restricting engagement in daily activities. Accordingly, adjunctive interventions implemented prior to exercise may enhance exercise tolerance and optimize therapeutic outcomes.Peloidotherapy, which involves the therapeutic application of natural medicinal mud, is commonly used in musculoskeletal rehabilitation due to its analgesic, muscle-relaxant, and circulation-enhancing effects. By alleviating pain and reducing muscular tension, peloidotherapy may facilitate greater participation in exercise programs and support improved clinical outcomes.This study aims to investigate the effects of adjunctive peloidotherapy administered before Schroth-based PSSE in young adults with scoliosis, focusing on pain, exercise adherence, and quality of life, with particular emphasis on SRS-22 measures..

Study of an Intrathecal Port and Catheter System for Subjects With Spinal Muscular Atrophy

The primary objective of the clinical investigation is to demonstrate successful clinical use of the ThecaFlex DRx™ System in delivering nusinersen in subjects with spinal muscular atrophy (SMA). All enrolled subjects will undergo implantation of the investigational device (ThecaFlex DRx™ System) and will be followed for 12 months after receiving the implant. The 12-month data will be used to assess the primary endpoint support a Pre-Market Approval (PMA) application.

The Effect of Three-Dimensional Exercises ( Schroth Method ) on Trunk Muscle Endurance, Sleep Quality, and Quality of Life in Adolescents With Hyperkyphosis

Adolescence is a critical period for spinal growth, and progression of thoracic hyperkyphosis may lead to pain, weak trunk muscles, sleep disturbances, and reduced quality of life. This study aims to investigate the effects of three-dimensional exercise program based on the Schroth Method on trunk muscle endurance, thoracic kyphosis angle, pain, sleep quality and quality of life in adolescents aged 12-18 years with hyperkyphosis.

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.

ABM/P-15 Bone Graft vs Traditional Bone Graft in Adult Spinal Deformity Surgery

The purpose of this prospective trial is to investigate ABM/P-15 bone graft versus traditional bone graft in patients undergoing surgery for Adult Spinal Deformity (ASD) in order to provide better clinical results through faster bone healing, no additional surgeries, fewer complications and thereby increase health-related quality of life. Main hypotheses: 1. The use of ABM/P-15 bone graft is superior to traditional bone graft treatment regarding the incidence of additional surgeries following index surgery for ASD Secondary hypotheses: 2. The investigators expect non-inferiority in patient reported outcome measures in the ABM/P-15 bone graft group compared to the control group 3. The investigators expect non-inferiority in the postoperative fusion rates (bone healing) evaluated on CT scans in the ABM/P-15 bone graft group compared to the control group 4. The investigators expect non-inferiority in postoperative incidence of asymptomatic pseudarthrosis in the ABM/P-15 bone graft group compared to the control group 5. The investigators expect non-inferiority in perioperative complications in ABM/P-15 bone graft group compared to the control group 6. The investigators expect the use of ABM/P-15 bone graft to be cost-efficient compared to the traditional treatment in the control group

Perioperative Morbidity in Adult Scoliotic Surgery: Analysis of a Series From Brest (MOSCA-B)

Scoliosis surgery is an invasive procedure essential for alleviating significant pain and improving the physical, psychological, aesthetic, professional, and social well-being of patients. However, it carries a considerable risk of perioperative complications. This retrospective study, conducted at Brest University Hospital since 2017, aims to analyze these complications to provide a detailed assessment, particularly since the introduction of the OARM (intraoperative CT navigation), with the goal of optimizing the safety and effectiveness of surgical interventions. The complications studied include neurological, infectious, mechanical, and cardiopulmonary complications, along with an additional "other" category for rare complications. The period analyzed extends from the immediate postoperative phase to the most recent follow-up consultation with the referring surgeon, which varies depending on the duration of follow-up for each patient.

Implementation of Momentum SpineTM: a New 3D Imaging Software for Idiopathic Scoliosis

Brief Summary The goal of this clinical trial is to evaluate the implementation of Momentum Spine™, a new 3D imaging software designed to improve the monitoring and management of idiopathic scoliosis in children aged 8-14 years. Idiopathic scoliosis affects 1-3% of the pediatric population and is currently monitored through hospital visits with radiographic imaging every 4-6 months, which exposes patients to cumulative radiation over time. This study explores whether Momentum Spine™ can provide a safer, more accessible alternative by enabling at-home monitoring using clinical photographs taken on smartphones. The primary questions this study seeks to answer are: Can Momentum Spine™ accurately predict scoliosis progression, including Cobb angle changes, compared to standard radiographic assessments? Can the use of Momentum Spine™ reduce the number of X-rays required and improve the timing of clinical follow-ups? Does the use of Momentum Spine™ affect patient satisfaction, healthcare utilization, and overall quality of life? This study is a prospective, two-arm randomized controlled trial conducted at CHU Sainte-Justine. Participants will be divided into two groups: the control group will receive standard care, which involves regular clinical visits and radiographic evaluations; the intervention group will use Momentum Spine™ at home, alongside standard care. Intervention Details Participants in the intervention group will: Use the Momentum Spine™ application to capture 3D images of their torso at home every two months. These images will be processed by Momentum Spine™ algorithms to assess curve progression. Participants will receive notifications and guidance on performing scans at home, supported by the study team to ensure accuracy. The primary outcomes include clinical measures such as changes in Cobb angle at 1 and 2 years, curve progression of more than 5 degrees, whether the main curve reaches 45 degrees, and the need for surgical referral. Secondary outcomes focus on the accuracy, sensitivity, and specificity of Momentum Spine™, as well as patient-reported measures such as health-related quality of life and satisfaction with care, users' acceptability of the software, healthcare services utilization and pathway costs. This study also aims to address key challenges in scoliosis care, including reducing radiation exposure, improving follow-up timing to align with growth spurts, and providing equitable access to care for families who may live far from specialty clinics. By validating the performance of Momentum Spine™, this trial has the potential to transform scoliosis management, ensuring safer and more effective care pathways.

Evaluating and Establishing the Relationship in the Five Critical X-ray Time Points in Spinal Deformity Realignment

To establish the relationship in the five critical X-ray time points during multilevel posterior column osteotomies (MPCO) spinal deformity realignment in patients with adult spinal deformity and to follow the participants longitudinally to examine any follow-up X-rays and clinical data to compare to the post-operative standing scan and pre-operative data.

Spine Deformity Patients With Optoelectronic Motion Capture

Aging-induced changes in the spine can lead to adult spinal deformity, causing a forward and/or lateral shift of the trunk. While mild cases may have compensatory mechanisms, severe deformities necessitate treatment. Surgery with instrumentation effectively corrects deformities, but complications are common. Precise pre-operative planning based on X-rays is essential. However, radiological imaging has limitations, including ionizing radiation exposure and static nature. Marker-based optoelectronic motion analysis systems offer potential benefits for dynamic spine assessment. This study aims to test the feasibility of using motion analysis systems to characterize spinal alignment and balance in patients with adult spine deformity. The primary objective is to assess the practical implementation, measurement capability, and resources required for motion analysis. Secondary objectives include investigating errors in absolute spinal curvature assessment and developing compensation strategies. The project will recruit 20 patients (non-operated and operated) seeking medical attention for adult spine deformities and 10 healthy controls. Participants will undergo biplanar imaging and motion analysis to capture static and dynamic spine alignment during common activities. The data will help build patient-specific musculoskeletal models, offering potential insights into improving surgical planning for adult spine deformities.

Evaluation of the IFuse Bedrock Technique in Association with Posterior Lumbosacral Fusion with Iliac Fixation.

The purpose of this study is to describe the impact of the iFuse Bedrock technique to decrease post-operative pains in patients who underwent multilevel posterior lumbosacral fusion.