Observational Study of The Tether4 Vertebral Body Tethering System for Progressive Idiopathic Scoliosis in Patients Up to 30 Years in the UK

What this Trial Is About

Researchers are collecting information on The Tether11, a device used in spine surgery for patients with progressive idiopathic scoliosis having Lenke Type 1 curves. This observational study aims to assess the ongoing safety and possible benefits of The Tether11 in such patients. The study is conducted by LDR Me9dical SAS and will enroll patients up to age 30 who are skeletally immature and have failed bracing or cannot tolerate it. Participants will receive Vertebral Body Tethering VBT surgery with The Tether11 device as part of their standard care. The study follows patients for five years after surgery to monitor safety and scoliosis progression. Data will be collected at the first follow-up after discharge, then at 6, 12, 24, 36, 48, and 60 months post-surgery. During the study, participants attend follow-up visits as part of their routine care where researchers collect data on adverse events, spine curvature maintenance, reoperations, device integrity, trunk shape and flexibility, pulmonary function, spine mobility, and patient-reported quality of life. The main outcomes include serious adverse events and the percentage of patients maintaining a major Cobb angle of 40 degrees or less at five years. Participants are observed for up to five years after surgery to gather long-term information.

PMCF (Post-Market Clinical Follow-up) Study on The Tether™ in UK (United Kingdom)