Scoliosis Idiopathic Clinical Trial
Official title:
The Tether™ - Vertebral Body Tethering System Post-Market Clinical Follow-Up Study in UK
The goal of this observational study is to collect information about The Tether™ device in participants with progressive idiopathic scoliosis, Lenke Type 1 curves. The main purpose is to provide assessment of: - ongoing safety - probable benefits Participants who will receive The Tether™ during spine surgery will have to attend follow-up visits which are part of standard-of-care.
This study is designed to be prospective. After the initial visit, followed by the surgery, the participant is expected to take part in the study for a time period of 5 years post-surgery. Patients will be enrolled during a period of 36 months, and the study will last until complete collection of the 5-year follow-up data. Data will be collected at: first follow-up post discharge, 6, 12, 24, 36, 48 and 60 months. ;
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