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

Recruiting Observational Study
Scoliosis Idiopathic
No Study Drug Researchers observe your health over time — no experimental treatment is given.
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At a Glance
Age
0 – 30
Sex
Any
Study type
Observational
Participants needed
100 (estimated)
Sponsor
LDR Médical SAS · Industry
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About This Trial

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.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Diagnosis of progressive idiopathic scoliosis; * Skeletally immature, based on both Risser (\<5) and Sanders (\<8) assessments; * Major Cobb angle ≥30° and ≤65°; * Osseous structure dimensionally adequate to accommodate screw fixation, as determined by radiographic imaging; * …
Contacts

Delphine Lebrasseur-Longuet

+33 626262240

ClinicalEMEA@highridgemedical.com

CONTACT