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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Scoliosis Idiopathic
• Intervention / Treatment: Procedure: Vertebral Body Tethering (VBT)

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.

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Delphine Lebrasseur-Longuet; Phone Number: +33 626262240; Email: ClinicalEMEA@highridgemedical.com

Study Locations

• United Kingdom
  • London, United Kingdom, SW17 0QT
    • Recruiting
    • Saint George's Hospital
    • Contact: Jason BERNARD, MD; Email: jason.bernard@stgeorges.nhs.uk
    • Contact: Jason BERNARD, MD
  • Newcastle Upon Tyne, United Kingdom
    • Recruiting
    • Freeman Hospital
    • Contact: Andrew BOWEY, MD; Email: andrew.bowey@nhs.net
    • Contact: Andrew BOWEY, MD
  • Southampton, United Kingdom
    • Recruiting
    • University Southampton Hospital
    • Contact: Andrew COTTAM, MD; Email: acottam@nhs.net
    • Contact: Andrew COTTAM, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Skeletally immature patients that require surgical treatment to obtain and maintain correction of progressive idiopathic scoliosis (Lenke Type 1 curves), with a major Cobb angle of 30 to 65 degrees whose osseous structure is dimensionally adequate to accommodate screw fixation, as determined by radiographic imaging. Patients should have failed bracing and/or be intolerant to brace wear.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of serious adverse events, and device- and/or procedure-related adverse events	Serious adverse events, and device- and/or procedure-related adverse events (including intra-operative) will be registered at any post-operative time point	5 years
Percentage of patients with maintenance of the major Cobb angle ≤ 40 degrees	Major Cobb angle will be measured by x-rays	60 months post-surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of overall adverse events, relatedness, severity, time to event	Adverse events (including intra-operative) will be registered at any post-operative time point	5 years
Rate and types of reoperations	Reoperations will be registered at any post-operative time point	5 years
Progression of secondary curves	Secondary curves will be assessed by x-rays	Pre-operative, first follow-up, 6, 12, 24, 36, 48 and 60 months post-surgery
Development of new curves	New curves development will be assessed by x-rays at each follow-up visit	First follow-up, 6, 12, 24, 36, 48 and 60 months post-surgery
Device integrity failures	Device integrity will be assessed by x-rays at each follow-up visit	First follow-up, 6, 12, 24, 36, 48 and 60 months post-surgery
Maintenance/change in Sagittal alignment, lumbar lordosis	Sagittal alignment and lumbar lordosis will be assessed by x-rays	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)	PROMs will be filled in by the participants at each visit. The SRS-22R measures quality of life in 5 domains: function, pain, self-image, mental health, and satisfaction/dissatisfaction. The minimum score in each domain is 1 and maximum is 5. Each item is scored from 1 (the worst) to 5 (the best). The EQ-5D-Y descriptive system will be used to assess the following five dimensions: mobility, looking after myself, doing usual activities, having pain or discomfort and feeling worried, sad or unhappy. Each dimension has 3 levels: no problems, some problems and a lot of problems. The associated Visual Analog Scale (from 0 - the worst health to 100 - the best health) can be used as a quantitative measure of health outcome that reflects the younger patient's own judgement.	Pre-operative, first follow-up, 6, 12, 24, 36, 48 and 60 months post-surgery
Pulmonary function	Pulmonary function test, using routine spirometry, will be performed at pre-operative, 24 and 60 months post-operative visits	Pre-operative, 24 and 60 months post-surgery
Trunk shape	Measurements of trunk shape will be collected at pre-operative and each follow-up visit with a standard scoliometer device	Pre-operative, first follow-up, 6, 12, 24, 36, 48 and 60 months post-surgery
Trunk flexibility	Trunk flexibility will be collected at pre-operative and each follow up visit. Clinical measurements will be done for both forward and lateral bending using the "fingertip- to- floor" method	Pre-operative, first follow-up, 6, 12, 24, 36, 48 and 60 months post-surgery
Spine mobility	Range of Motion will be evaluated by x-rays pre-operatively and at each follow-up visits	Pre-operative, first follow-up, 6, 12, 24, 36, 48 and 60 months post-surgery

Collaborators and Investigators

• Sponsor: LDR Médical SAS
• Investigators: Principal Investigator: Jason Bernard, MD, Saint George's Hospital, London

Publications and helpful links

General 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 18, 2024
• Primary Completion (Estimated): January 30, 2033
• Study Completion (Estimated): December 1, 2033

Study Registration Dates

• First Submitted: March 30, 2023
• First Submitted That Met QC Criteria: April 13, 2023
• First Posted (Actual): April 26, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 20, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Vertebral Body Tethering; Fusionless Spine Surgery
• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Spinal Diseases; Spinal Curvatures; Scoliosis
• Other Study ID Numbers: SP-PMCF-EU-202301

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No