PMCF Study on The Tether™ in UK
Research type
Research Study
Full title
The Tether™ - Vertebral Body Tethering System Post-Market Clinical Follow-Up Study in UK
IRAS ID
326641
Contact name
Jason Bernard
Contact email
Sponsor organisation
LDR Médical SAS
Clinicaltrials.gov Identifier
Duration of Study in the UK
8 years, 7 months, 1 days
Research summary
The study aims to provide additional data on the ongoing safety and probable benefit of The Tether™ - VBT System in treating skeletally immature patients with progressive idiopathic scoliosis (IS). Idiopathic means that the cause of the condition is unknown. This device is a non-fusion spinal device intended for the treatment of IS. The patient population will include patients whose clinicians made the decision to treat their condition with the device outside of this research study. The study is a multi-centre, single-arm, prospective, Post-Market Clinical Follow-up (PMCF) study. All the examinations and assessments performed during the study are standard-of-care. Study data will be collected from source documents only. Once enrolled, the participant is anticipated to partake in the study for a time period of 5 years post-surgery. Postoperative follow-up intervals are conducted at the first post-op visit, 6, 12, 24, 36, 48 and 60 months. As this observational study consists of standard-of-care follow-up only, without any additional visits or exams, and no study drug or intervention, data will continue to be collected until the participant completes the study. The following corresponding data will be collected: (a) physical examination, (b) medical history, (c) pre-operative, operative and immediate post-op/discharge data, (c) radiological examination (d) scoliometer examination (e) pulmonary tests (f) questionnaires (g) device- or procedure-related adverse event assessments, (h) trunk flexibility assessments.
REC name
West Midlands - South Birmingham Research Ethics Committee
REC reference
23/WM/0090
Date of REC Opinion
22 May 2023
REC opinion
Further Information Favourable Opinion