Active clinical trials for "Scoliosis"

The implementation of an mechanical in-exsufflator device (MI-E) requires specific expertise because it is a complex device that requires fine-tuning of the settings according to different clinical situations to optimize its effectiveness. Generally, it is performed by experienced physiotherapists in neuromuscular disease reference centers or directly at home via medical-technical home care providers. Treatment data is recorded by the machine at each MI-E session, which may be daily or less frequent, depending on the patient's dependency. All of this information can be accessed by manually downloading the data from the SD card that comes with each MI-E machine. Therefore, the retrieval of this information systematically requires the visit of staff to the patient's home. To date, compliance with these devices is not regularly measured since there is no means of telecommunication allowing remote monitoring of these therapies, whereas technological development in the field of remote monitoring has allowed remote monitoring of patients with sleep apnea syndrome treated with continuous positive airway pressure (CPAP) and, more recently, of some patients with chronic respiratory insufficiency treated with invasive ventilation (NIV). These developments are transforming on the one hand the follow-up of patients under NIV at home by the medical and paramedical teams and on the other hand the financial coverage by the health insurance organizations (ETAPES programs). Within the framework of NIV therapy, we think that remote monitoring of the quality of the sessions, i.e. measurement of peak expiratory flow, insufflated volumes, frequency and duration of the sessions, could facilitate and improve the follow-up of these patients for the medical-technical providers, the expert physiotherapists and the doctors of the reference centers. It is still too early to assume the extent to which data from remote monitoring of MI-E devices would improve patient follow-up. Nevertheless, given the increasing number of devices installed over the past several years, it is likely that the issue of telemonitoring will become a central issue. Thus, in this observational trial, we propose to evaluate the feasibility of a simple system of remote monitoring of MI-E devices in non-therapy-naive patients, with the objective of assessing the barriers and limitations of remote monitoring in this population. Primary aim is to evaluate the feasibility of remote monitoring of data from the MI-E device used in the patient's home in neuromuscular diseases. Patients will be identified by the investigators using the AGIR à dom software package (medical-technical follow-up file). If the patient accepts, the information and no-objection form will be sent to them electronically or by mail following this call, and at least 3 days before their scheduled appointment. During the patient's usual follow-up visit, if the patient does not object to participating in the study, AGIR staff in dom will install the device. This visit will take place in the patient's home. During this visit, a SanDisk (SD) Eye-Fi SDHC 4GB + WiFi Class4 memory card will be inserted into the port provided, in place of the memory card already present in the MI-E device. Then a Raspberry Pi 4 Model B will be placed in the room where the MI-E device is normally used by the patient, and connected to a power source (accessible electrical outlet in the room). The wifi SD card, which uses the device's power supply, will communicate with the Raspberry Pi via the wifi network and upload the recorded data each time the MI-E device is used. After 90 days, a routine recovery visit will be scheduled. AGIR à dom staff will replace the wifi SD card installed during the D0 visit with the standard SD card originally provided with the MI-E device. The data locally on the SD Wifi card will then be downloaded for analysis and comparison with the data being uploaded

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.

To examine the clinical efficacy of the Orthopaedic Manipulation Techniques of the Lin School of Lingnan Region in the treatment of Adolescent Idiopathic Scoliosis

This is a retrospective, observational multi-center study. The participants undergone lumbar spine surgery for degenerative lumbar scoliosis and followed up for at least 2 years are retrospectively enrolled from 8 centers. This study mainly focuses on the short-term and long-term outcomes of lumbar surgery in participants with degenerative lumbar scoliosis, and that how much the surgical outcomes are related with demographic, surgical, and radiographic features before and after surgery. The objective is to offer more detailed clinical evidence to guide the surgical strategy development for degenerative lumbar scoliosis.

This study has to purpose Yoga and Meditation before surgery for idiopathic scoliosis. Protocol's observance will tell the investigators if it is feasible and appropriate in a University hospital center.

Scoliosis is a three-dimensional torsional deformation of the spine and trunk. Chest deformity and pelvic asymmetry are often seen together with spinal deformity. Adolescent idiopathic scoliosis occurs from the onset of puberty until growth plate closure and is the most common of all scoliosis. One of the most common deformities among posture disorders is known as scoliosis. The change in load distribution resulting from this three-dimensional deformation causes postural changes in patients with idiopathic scoliosis. According to a study, it is thought that postural control and central information processing efficiency may decrease as the Cobb angle increases in people with scoliosis.

Adolescent idiopathic scoliosis (AIS) is the most common three-dimensional deformity of the spine that is typically characterized by curvature in both the coronal and sagittal planes. Selective thoracolumbar fusion (STLF) surgery, is an established corrective surgical technique for spinal deformities with excellent outcomes over time1. The objective of AIS corrective surgery encompasses the rectification of coronal and spinal rotation deformities while concurrently restoring the sagittal profile. However, some scholars suggested that correcting the Cobb angle and rotation deformity of the main thoracic curve has been associated with a sacrifice of sagittal plane aligament. Some researchers observed that significant reduction of thoracic kyphosis (TK) after the coronal deformity was corrected in their study3-5. In addition, Li et al3 found that both lumbar lordosis(LL) and sacral slope (SS) decreased after STLF surgery in their study. The sagittal plane of the spine column should be considered a chain-like structure, one section's change, that leads to compensatory changes in other segments, enables the maintenance of balance6. In addition, some scoloars suggested that the decrease in thoracic kyphosis may caused by vertebral derotation in STLF surgery. Postoperative shoulder imbalance (PSI) is a common complication that arises following STLF surgery, significantly impacting the appearance and satisfaction of patients8. The incidence of PSI varies within a range of 25% to 57%. It is imperative to identify the independent risk factors of PSI which can help in comprehending this phenomenon better and further aiding in deduction of the incidence rate. Although the research on the risk factors for PSI in AIS patients have been conducted for several years , no conclusively determination has been reached. Recently, scholars have been studying the relationship between the rotation of the thoracic spinal column and postoperative shoulder balance. Yagi et al.'s study10 has identified the preoperative rotation of the main thoracic apical vertebrae as a risk factor for PSI. Additionally, Masayoshi et al has reported on the relationship between the rotation of the proximal thoracic apical vertebrae and postoperative shoulder height disatance. In summary, it can be hypothesized that the preoperative and changes of postoperative sagittal spinal parameters may impact the postoperative shoulder balance among AIS patients. However, there is a paucity of literature investigating the effect of sagittal spinal parameters on PSI after STLF surgery. Therefore, the purpose of this study is to examine the correlation between the preoperative and postoperative alterations of sagittal spinal parameters and PSI.

Effect of perineurial dexamethasone and dexmedetomidine on erector spinal plane block duration for pediatric, idiopathic scoliosis surgery.

Scoliosis is a three-dimensional deformity affecting the orientation and position of the spine. Locally, the shape of the vertebra is also affected. The most common form is adolescent idiopathic scoliosis (AIS) with a prevalence of 1-3% affecting primarily young adolescent females. AIS can either be treated using a brace and in some cases necessitate surgical correction to prevent progressive deformity. Risk factors for progression include female gender, curve magnitude and location, skeletal maturity and growth velocity. However, these risk factors have been shown to be inconsistent in predicting curve progression. Over the past 6 years, the investigators have developed a predictive model of the final Cobb angle in AIS based on 3D spinal parameters. This analysis was based on a prospective cohort of 195 patients that were enrolled upon their initial visit and followed until maturity. This predictive model has a determination coefficient of 0.702. The proposed new study aims at refining and testing the external validity of this model in a larger cohort. The next step towards using the new model in the clinical setting is to redesign the model and to externally validate the model by measuring the agreement between the new method and the traditional Cobb angle at maturity in a larger multicenter study. The objective of this study is to characterize the risk of scoliosis progression based on local three-dimensional vertebral and pelvic measurements present on initial evaluation. Three-dimensional reconstructions will be derived from stereo-radiographs acquired with a new biplanar low-dose radiographic system installed in all 8 clinical sites (EOS system, EOS-Imaging, Paris). These calibrated radiographs will then be used to reconstruct the vertebrae and intervertebral disks at each level as well as the geometry of the pelvis. A series of local and regional parameters will then be calculated from these 3D reconstructions. Correlation analysis will help determine if intervertebral disk wedging, vertebral wedging, transverse plane rotation or pelvic geometry can be used as early predictors of curve progression in AIS. Identifying a new 3D measure of scoliosis associated with rapid curve progression could help predict which curves need early treatment to prevent further progression. The ultimate goal of this research project will be to validate this new predictive model and finally transfer this new predictive tool in the hands of clinicians treating AIS.

The objective of the study will be to estimate the correction obtained with a metallic instrumentation, by mini-invasive technique with bipolar assembly and ilio-sacred EUROS ®) screw , without transplant at the adult as compared to that obtained with the surgery with complete exhibition of the rachis and bone graft.