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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Scoliosis Idiopathic

Intervention / Treatment
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* Procedure: Vertebral Body Tethering (VBT)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 0 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Vertebral Body Tethering (VBT)|Vertebral Body Tethering surgery with the Tether™ in UK|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vertebral Body Tethering, Fusionless Spine Surgery