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

Launched by LDR MÉDICAL SAS · Apr 13, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a device called The Tether™ to help treat children and adolescents with progressive idiopathic scoliosis, specifically those with Lenke Type 1 curves. The main aim of the study is to gather information on how safe the device is and what benefits it may provide to patients. Participants who receive The Tether™ during their spine surgery will need to attend follow-up visits, which are standard care after surgery, to monitor their progress.

To be eligible for this study, patients should be diagnosed with progressive idiopathic scoliosis, be still growing (skeletally immature), and have a significant curve in their spine (between 30° and 65°). They should not have had prior spinal surgery in the same area, and they must have tried and been unable to effectively use a back brace. Additionally, participants must be able to attend follow-up visits and provide consent for the study. Overall, this trial aims to ensure the ongoing safety of The Tether™ device and evaluate its potential benefits for young patients with scoliosis.

Gender

ALL

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, allergies to the implant materials, and patients unwillingness or inability to cooperate with post-operative care instructions;
• • Unwillingness, inability, or living situation (e.g., custody arrangements, homelessness, detention) that would preclude ability to return to the study site for follow-up visits as described in protocol and Informed Consent;
• • Patients who are pregnant at the time of enrollment.