Actively Recruiting
PMCF (Post-Market Clinical Follow-up) Study on The Tether™ in UK (United Kingdom)
Led by LDR Médical SAS · Updated on 2025-03-21
100
Participants Needed
3
Research Sites
489 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
PMCF (Post-Market Clinical Follow-up) Study on The Tether™ in UK (United Kingdom)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of progressive idiopathic scoliosis
- Skeletally immature based on Risser (<5) and Sanders (<8) assessments
- Major Cobb angle between 306 and 656
- Bone structure adequate for screw fixation as shown by imaging
- Failed bracing or unable to tolerate brace wear
- Lenke Type 1 (main thoracic) curves
- Signed Informed Consent by guardian or patient if 16 years or older
- Treatment decision with The Tether12 made by patient's clinician outside this study
You will not qualify if you...
- Any systemic, local infection, or skin problems at surgical site
- Prior spinal surgery at treated levels
- Poor bone quality (T-score -1.5 or less)
- Skeletal maturity
- Medical or surgical conditions preventing spine surgery benefit (e.g., bleeding disorders, allergies to implant materials)
- Unwillingness or inability to follow post-op care or attend follow-ups
- Living situations preventing follow-up visits (e.g., custody issues, homelessness, detention)
- Pregnant at enrollment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Saint George's Hospital
London, United Kingdom, SW17 0QT
Actively Recruiting
2
Freeman Hospital
Newcastle upon Tyne, United Kingdom
Actively Recruiting
3
University Southampton Hospital
Southampton, United Kingdom
Actively Recruiting
Research Team
D
Delphine Lebrasseur-Longuet
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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