View clinical trials related to Adolescent Idiopathic Scoliosis.
Filter by:The Green Sun Medical Dynamic Brace (GSM) brace was developed as an alternative to rigid thoracolumbosacral orthoses (TLSOs, braces) commonly used to prevent continued curve progression in patients with adolescent idiopathic scoliosis (AIS). The brace applies corrective forces to the muscular and bony structures of the spine while preserving range of motion (ROM). The innovative design of this brace should provide an equivalent degree of correction of the scoliotic curvature as a rigid TLSO, with increased acceptability to the patient via improved comfort and spinal/chest wall mobility. Increased acceptability promotes increased adherence to treatment. This is a pilot study to collect preliminary short-term data concerning the safety and performance of the GSM brace in a sample of subjects with AIS who are currently being treated with a TLSO. The study will use clinical exams, x-rays, monitoring equipment, and questionnaires to primarily assess safety and performance. Secondary endpoints include spinal ROM and lung vital capacity assessment, as well as data validation. The study involves 3 visits, a performance check phone call, and 4 follow up calls over a four month span. This is a pilot study and no formal hypothesis testing will be done. Descriptive statistics of selected variables will be calculated.
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. A total of 10 patients, who are planned to undrego the MID-C System implantation procedure will be enrolled for the study. A 5 years follow-up post surgery will be performed for these patients in order to evaluate the long term safety and efficacy of the MID-C System.
Evaluation of the efficacy of the K2M MESA Rail™ Deformity System at improving coronal and sagittal correction of the adolescent idiopathic spine deformity in comparison to the side loading DePuy Synthes USS II pedicle screw system.
The purpose of this pilot study is to determine the presence, frequency, and severity of mental health disorders amongst adolescents undergoing spinal surgery for scoliosis.