PMCF (Post-Market Clinical Follow-up) Study on The Tether™ in UK (United Kingdom)
ConditionScoliosis Idiopathic
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age0-30
SponsorLDR Médical SAS
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.
Eligibility criteria
Qualifiers
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;
Disqualifiers
Presence of any systemic infection, local infection, or skin compromise at the surgical site;
Prior spinal surgery at the level(s) to be treated;
Known poor bone quality defined as a T-score -1.5 or less;
Skeletal maturity;
Trial design
Treatments tested in this trial
- Vertebral Body Tethering (VBT)
Treatment groups
No treatment groups listed
Sponsors and collaborators
Source ClinicalTrials.gov