RecruitingNCT05830825

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

The Tether™ - Vertebral Body Tethering System Post-Market Clinical Follow-Up Study in UK


Sponsor

LDR Médical SAS

Enrollment

100 participants

Start Date

Jul 18, 2024

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 0 YearsMax Age: 30 Years

Plain Language Summary

Simplified for easier understanding

This study is following young patients in the United Kingdom who have been treated with The Tether — a vertebral body tethering (VBT) system — for progressive idiopathic scoliosis. Scoliosis is an abnormal sideways curvature of the spine, and in growing children, it can worsen rapidly. Unlike traditional spinal fusion surgery, which permanently locks vertebrae together and limits flexibility, VBT uses a flexible cord attached to screws along the spine to guide the curve to correct gradually as the child grows — preserving motion and spinal flexibility. Skeletally immature patients (still growing, based on Risser and Sanders scores) with a main thoracic curve (Lenke Type 1) between 30 and 65 degrees who have already failed bracing are eligible. The treatment decision must already have been made by the patient's clinical team — this is a follow-up study, not a trial of whether to use the device. Patients with spinal infections, prior spinal surgery at the treated levels, known poor bone quality, or pregnancy at enrollment are excluded. Participants are tracked over time to assess curve correction, complications, and quality of life. This post-market study is important because VBT is a relatively new approach and long-term real-world data — particularly from UK populations — are still being gathered. Understanding its durability and outcomes will help surgeons and families make better-informed decisions about this growth-guided alternative to fusion.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREVertebral Body Tethering (VBT)

Vertebral Body Tethering surgery with the Tether™ in UK


Locations(3)

Saint George's Hospital

London, United Kingdom

Freeman Hospital

Newcastle upon Tyne, United Kingdom

University Southampton Hospital

Southampton, United Kingdom

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NCT05830825


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