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.
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
100
Vertebral Body Tethering surgery with the Tether™ in UK
Saint George's Hospital
London, United Kingdom
RECRUITINGFreeman Hospital
Newcastle upon Tyne, United Kingdom
RECRUITINGUniversity Southampton Hospital
Southampton, United Kingdom
RECRUITINGRate 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
Time frame: 5 years
Percentage of patients with maintenance of the major Cobb angle ≤ 40 degrees
Major Cobb angle will be measured by x-rays
Time frame: 60 months post-surgery
Rate of overall adverse events, relatedness, severity, time to event
Adverse events (including intra-operative) will be registered at any post-operative time point
Time frame: 5 years
Rate and types of reoperations
Reoperations will be registered at any post-operative time point
Time frame: 5 years
Progression of secondary curves
Secondary curves will be assessed by x-rays
Time frame: 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
Time frame: 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
Time frame: First follow-up, 6, 12, 24, 36, 48 and 60 months post-surgery
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Maintenance/change in Sagittal alignment, lumbar lordosis
Sagittal alignment and lumbar lordosis will be assessed by x-rays
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)
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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Pre-operative, first follow-up, 6, 12, 24, 36, 48 and 60 months post-surgery