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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Процедура Vertebral Body Tethering (VBT)
  Vertebral Body Tethering surgery with the Tether™ in UK

Первичные конечные точки

• Rate of serious adverse events, and device- and/or procedure-related adverse events [Срок оценки: 5 years]
• Percentage of patients with maintenance of the major Cobb angle ≤ 40 degrees [Срок оценки: 60 months post-surgery]

Вторичные конечные точки (11)

• Rate of overall adverse events, relatedness, severity, time to event [Срок оценки: 5 years]
• Rate and types of reoperations [Срок оценки: 5 years]
• Progression of secondary curves [Срок оценки: Pre-operative, first follow-up, 6, 12, 24, 36, 48 and 60 months post-surgery]
• Development of new curves [Срок оценки: First follow-up, 6, 12, 24, 36, 48 and 60 months post-surgery]
• Device integrity failures [Срок оценки: First follow-up, 6, 12, 24, 36, 48 and 60 months post-surgery]
• Maintenance/change in Sagittal alignment, lumbar lordosis [Срок оценки: 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) [Срок оценки: Pre-operative, first follow-up, 6, 12, 24, 36, 48 and 60 months post-surgery]
• Pulmonary function [Срок оценки: Pre-operative, 24 and 60 months post-surgery]
• Trunk shape [Срок оценки: Pre-operative, first follow-up, 6, 12, 24, 36, 48 and 60 months post-surgery]
• Trunk flexibility [Срок оценки: Pre-operative, first follow-up, 6, 12, 24, 36, 48 and 60 months post-surgery]
• Spine mobility [Срок оценки: Pre-operative, first follow-up, 6, 12, 24, 36, 48 and 60 months post-surgery]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Только случаи

Центры проведения

Великобритания · 3 центра

• Saint George's Hospital — London
• Freeman Hospital — Newcastle upon Tyne
• University Southampton Hospital — Southampton

Публикации

• 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

Идентификаторы

NCT: NCT05830825 · SP-PMCF-EU-202301

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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