The Tether™ - Vertebral Body Tethering System Post-Market Clinical Follow-Up Study in UK

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Procedure
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Maximum Age: 30
Healthy Volunteers: f
View:

• 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;

• Failed bracing and/or be intolerant to brace wear;

• Lenke Type 1 curves (i.e., main thoracic);

• Signed Informed Consent Form by legal guardian or by the patient if ≥ 16 years old.

• The decision to treat patients with The Tether™ - VBT System was made by the patient's clinician outside of this research

Locations
Other Locations
United Kingdom
Saint George's Hospital
RECRUITING
London
Freeman Hospital
RECRUITING
Newcastle Upon Tyne
University Southampton Hospital
RECRUITING
Southampton
Contact Information
Primary
Delphine Lebrasseur-Longuet
ClinicalEMEA@highridgemedical.com
+33 626262240
Time Frame
Start Date: 2024-07-18
Estimated Completion Date: 2033-12
Participants
Target number of participants: 100
Related Therapeutic Areas
Sponsors
Leads: LDR Médical SAS

This content was sourced from clinicaltrials.gov