PMCF (Post-Market Clinical Follow-up) Study on The Tether™ in UK (United Kingdom)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Vertebral Body Tethering (VBT).
- Who it may be relevant to
- Registry conditions: Scoliosis Idiopathic. Basic parameters: 0 years — 30 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
The Tether™ - Vertebral Body Tethering System Post-Market Clinical Follow-Up Study in UK
Overview
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.
Detailed description
This study is designed to be prospective. After the initial visit, followed by the surgery, the participant is expected to take part in the study for a time period of 5 years post-surgery.
Patients will be enrolled during a period of 36 months, and the study will last until complete collection of the 5-year follow-up data. Data will be collected at: first follow-up post discharge, 6, 12, 24, 36, 48 and 60 months.
Interventions
- Procedure Vertebral Body Tethering (VBT)
Vertebral Body Tethering surgery with the Tether™ in UK
Primary outcome measures
- Rate of serious adverse events, and device- and/or procedure-related adverse events [Time frame: 5 years]
- Percentage of patients with maintenance of the major Cobb angle ≤ 40 degrees [Time frame: 60 months post-surgery]
Secondary outcome measures (11)
- Rate of overall adverse events, relatedness, severity, time to event [Time frame: 5 years]
- Rate and types of reoperations [Time frame: 5 years]
- Progression of secondary curves [Time frame: Pre-operative, first follow-up, 6, 12, 24, 36, 48 and 60 months post-surgery]
- Development of new curves [Time frame: First follow-up, 6, 12, 24, 36, 48 and 60 months post-surgery]
- Device integrity failures [Time frame: First follow-up, 6, 12, 24, 36, 48 and 60 months post-surgery]
- Maintenance/change in Sagittal alignment, lumbar lordosis [Time frame: Pre-operative, first follow-up, 6, 12, 24, 36, 48 and 60 months post-surgery]
- Patient Reported Outcome Measures (PROMs): Scoliosis Research Society Health-Related Quality of Life Questionnaire (SRS-22r) and EuroQol 5 Dimensions Young (EQ-5D-Y) [Time frame: Pre-operative, first follow-up, 6, 12, 24, 36, 48 and 60 months post-surgery]
- Pulmonary function [Time frame: Pre-operative, 24 and 60 months post-surgery]
- Trunk shape [Time frame: Pre-operative, first follow-up, 6, 12, 24, 36, 48 and 60 months post-surgery]
- Trunk flexibility [Time frame: Pre-operative, first follow-up, 6, 12, 24, 36, 48 and 60 months post-surgery]
- Spine mobility [Time frame: Pre-operative, first follow-up, 6, 12, 24, 36, 48 and 60 months post-surgery]
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;
- 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
Exclusion criteria
- 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;
- Any other medical or surgical condition which would preclude the potential benefit of spinal surgery, such as coagulation disorders, allergies to the implant materials, and patients unwillingness or inability to cooperate with post-operative care instructions;
- Unwillingness, inability, or living situation (e.g., custody arrangements, homelessness, detention) that would preclude ability to return to the study site for follow-up visits as described in protocol and Informed Consent;
- Patients who are pregnant at the time of enrollment.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
United Kingdom · 3 centers
- Saint George's Hospital — London
- Freeman Hospital — Newcastle upon Tyne
- University Southampton Hospital — Southampton
Publications
- Cheung ZB, Selverian S, Cho BH, Ball CJ, Kang-Wook Cho S. Idiopathic Scoliosis in Children and Adolescents: Emerging Techniques in Surgical Treatment. World Neurosurg. 2019 Oct;130:e737-e742. doi: 10.1016/j.wneu.2019.06.207. Epub 2019 Jul 5. PMID 31284059
- El-Hawary R, Chukwunyerenwa C. Update on evaluation and treatment of scoliosis. Pediatr Clin North Am. 2014 Dec;61(6):1223-41. doi: 10.1016/j.pcl.2014.08.007. Epub 2014 Sep 12. PMID 25439021
- Kikanloo SR, Tarpada SP, Cho W. Etiology of Adolescent Idiopathic Scoliosis: A Literature Review. Asian Spine J. 2019 Jun;13(3):519-526. doi: 10.31616/asj.2018.0096. Epub 2019 Feb 13. PMID 30744305
Identifiers
NCT: NCT05830825 · SP-PMCF-EU-202301