Evaluation of a Growth Guiding Construct vs. Standard Dual Growing Rods and VEPTR for the Treatment of Early Onset Scoliosis Patients: A Prospective Multi-center Cohort Study With a Matched Historical Control

Fecha de inicio: 1 de junio de 2015

Inclusion Criteria: Age 5 - 10 years Diagnosis of Early Onset Scoliosis with any of the following etiologies: Idiopathic Congenital Neuromuscular Syndromic Mesenchymal - Significant growth potential defined by any of the following: pre peek growth velocity bone age < 10; open triradiate cartilage An expected significant spinal deformity of more than 80 degrees at skeletal maturity Signed informed consent as legally required (patient, parents, etc.) Willingness and ability of the patient to participate in the clinical investigation including imaging and FU procedures Willingness and ability of the parents to support the patient in his/her study participation Ability of the patient and parents to understand the content of the patient information / informed consent form and participate in the clinical investigation Signed informed consent by patient / parent(s) Exclusion Criteria: Curve magnitude and rigidity: Cobb greater than 100 degrees or bends less than 50 degrees Prior spinal surgery Skeletal maturity Any not medically managed severe systemic disease Participation in any other medical device or medicinal product study within the previous month that could influence the results of the present study