PMCF (Post-Market Clinical Follow-up) Study on The Tether™ in UK (United Kingdom)
Trial Parameters
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * Diagnosis of progressive idiopathic scoliosis; * Skeletally immature, based on both Risser (\<5) and Sanders (\<8) assessments; * Major Cobb angle ≥30° and ≤65°; * Osseous structure dimensionally adequate to accommodate screw fixation, as determined by radiographic imaging; * Failed bracing and/or be intolerant to brace wear; * Lenke Type 1 curves (i.e., main thoracic); * Signed Informed Consent Form by legal guardian or by the patient if ≥ 16 years old. * The decision to treat patients with The Tether™ - VBT System was made by the patient's clinician outside of this research Exclusion Criteria: * Presence of any systemic infection, local infection, or skin compromise at the surgical site; * Prior spinal surgery at the level(s) to be treated; * Known poor bone quality defined as a T-score -1.5 or less; * Skeletal maturity; * Any other medical or surgical condition which would preclude the potential benefit of spinal surgery, such as coagulation disorders, allergie