NCT05830825

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: LDR Médical SAS · Industry
• Sex: All
• Age: 0 Years – 30 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study is designed to be prospective. After the initial visit, followed by the surgery, the participant is expected to take part in the study for a time period of 5 years post-surgery. Patients will be enrolled during a period of 36 months, and the study will last until complete collection of the 5-year follow-up data. Data will be collected at: first follow-up post discharge, 6, 12, 24, 36, 48 and 60 months.

Conditions

• Scoliosis Idiopathic

Interventions

Type	Name	Description
PROCEDURE	Vertebral Body Tethering (VBT)	Vertebral Body Tethering surgery with the Tether™ in UK

Timeline

• Start date: 2024-07-18
• Primary completion: 2033-01-30
• Completion: 2033-12-01
• First posted: 2023-04-26
• Last updated: 2025-03-21

Locations

3 sites across 1 country: United Kingdom