Study of the NEMOST V2 Growing Domino Device for Surgical Treatment of Progressive Scoliosis in Children Ages 5 to 17

What this Trial Is About

Researchers are evaluating the NEMOST spinal implant, a growth domino device designed for surgical treatment of progressive scoliosis in children. This study is a post-market surveillance clinical trial conducted by EUROS to collect both retrospective and prospective clinical and radiological data. The main goal is to monitor complications and performance of the NEMOST growth domino over a five-year postoperative period in children with progressive scoliosis. The study involves the use of the NEMOST V2 growing domino device during surgery to treat children aged 5 to 17 years with progressive scoliosis that requires surgical intervention. This is an interventional, non-randomized, and uncontrolled study enrolling approximately 140 patients. Participants will be followed for five years after surgery to assess safety and device performance. During the study, participants will be monitored through clinical evaluations and radiological assessments to track complication rates and scoliosis progression. Researchers will measure outcomes such as Cobb angle, pelvic obliquity, thoracic kyphosis, lumbar lordosis, spinal length, and respiratory function over five years. Patient-reported outcomes will be collected using the Early-Onset Scoliosis questionnaire. The total study participation involves regular follow-ups during the five-year postoperative period.

Post-market Clinical Follow-up Study of NEMOST V2