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RECRUITING
NCT05830825

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

Sponsor: LDR Médical SAS

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

0 Years - 30 Years

Study Type

OBSERVATIONAL

Enrollment

100

Start Date

2024-07-18

Completion Date

2033-12

Last Updated

2025-03-21

Healthy Volunteers

No

Interventions

PROCEDURE

Vertebral 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