PMCF (Post-Market Clinical Follow-up) Study on The Tether™ in UK (United Kingdom)
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
| Condition(s) | Scoliosis Idiopathic |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| 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. |
| Who can participate | 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 |
| Ages | 0 Years to 30 Years |
| Sex | All |
| Lead sponsor | LDR Médical SAS |
| Locations | London, United Kingdom; Newcastle upon Tyne, United Kingdom; Southampton, United Kingdom |
| Start date | 2024-07-18 |
| NCT ID | NCT05830825 |
| Official listing | https://clinicaltrials.gov/study/NCT05830825 |