View clinical trials related to Adolescent Idiopathic Scoliosis.
Filter by:Observational case-control study to see if the Margin of Stability and Dynamic Postural Stability (measured using a motion capture gait laboratory and wearable device, respectively) are different in children with Adolescent Idiopathic Scoliosis and matched controls. Participants will walk across level ground and on a treadmill once for data collection and no follow-up is required.
Background- Adolescent idiopathic scoliosis is the most common indication for major surgery in adolescents. The current standard of care for adolescent idiopathic scoliosis (AIS) with a curve magnitude of over 40-50˚ in skeletally immature patients, is posterior spinal fusion with pedicle screws. Vertebral body tethering using screws connected by a tether in the anterior vertebral body, has the potential to initially correct the still flexible deformity, but most importantly modulate growth and ultimately result in scoliosis correction with a mobile spine. A high-quality comparative prospective study is missing to demonstrate the effectiveness and safety of vertebral body tethering compared to posterior spinal fusion. Study Design- An international, randomized clinical trial on posterior spinal fusion with pedicle screws vs. Anterior vertebral body tethering in Adolescent Idiopathic Scoliosis (AIS) Aims- To demonstrate non-inferiority of VBT compared to posterior fusion in terms of main curve correction of AIS at the 2 year follow up, to demonstrate comparable outcomes for SRS-22/24 at the 2 year follow up. Aim is also to compare complication and revision rates and to compare spinal mobility including flexion and side bending between the study groups. Inclusion criteria- Lenke type I A,B or C, age 10-16 years, skeletally immature, Cobb angle 40-60˚, 50% flexibility on supine bending films, selective thoracic fusion feasible Exclusion criteria- Any other than idiopathic scoliosis, less than 50% curve flexibility, skeletal maturity, patients who have evidence of neurological disorders, patients who have undergone intrathoracic surgery Outcome parametres- Cobb angle correction of instrumented curve at 2 year follow up, total score of SRS questionnaire at 2 year follow up; secondary outcomes: Complication and revision rates, pulmonary function at 2-year follow-up, spinal mobility at 2-year follow-up Ethical aspects- Each institution in each country is responsible for obtaining either institutional review board approval or approval from a national ethics committee as appropriate. An informed consent will be obtained from all children and their parents.