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

NCT05830825 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2025-03-21

No results posted yet for this study

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.

Conditions

  • Scoliosis Idiopathic

Interventions

PROCEDURE

Vertebral Body Tethering (VBT)

Vertebral Body Tethering surgery with the Tether™ in UK

Sponsors & Collaborators

  • LDR Médical SAS

    lead INDUSTRY

Principal Investigators

  • Jason Bernard, MD · Saint George's Hospital, London

Eligibility

Min Age
0 Years
Max Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-18
Primary Completion
2033-01-30
Completion
2033-12-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05830825 on ClinicalTrials.gov