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

Scoliosis Idiopathic

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 clinical trial is studying a procedure called Vertebral Body Tethering (VBT) for people with scoliosis idiopathic. The study is currently recruiting participants at 3 locations.

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

View Full Details on ClinicalTrials.gov

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NCT05830825

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