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PMCF (Post-Market Clinical Follow-up) Study on The Tether™ in UK (United Kingdom)
Sponsor: LDR Médical SAS
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
Conditions
Interventions
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