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The goal of this observational study is to collect information about The Tetherâ„¢ device in participants with progressive idiopathic scoliosis, Lenke Type 1 curves. The main purpose is to provide assessment of:
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vertebral Body Tethering (VBT) | Procedure | Vertebral Body Tethering surgery with the Tetherâ„¢ in UK |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Delphine Lebrasseur-Longuet | Contact | +33 626262240 | ClinicalEMEA@highridgemedical.com |
| Name | Affiliation | Role |
|---|---|---|
| Jason Bernard, MD | Saint George's Hospital, London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Saint George's Hospital | Recruiting | London | SW17 0QT | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31284059 | Background | 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. | |
| 25439021 | Background | 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. |
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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 |
| Freeman Hospital | Recruiting | Newcastle upon Tyne | United Kingdom |
|
| University Southampton Hospital | Recruiting | Southampton | United Kingdom |
|
| 30744305 | Background | 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. |