NCT05830825 PMCF (Post-Market Clinical Follow-up) Study on The Tether™ in UK (United Kingdom)
| NCT ID | NCT05830825 |
| Status | Recruiting |
| Phase | — |
| Sponsor | LDR Médical SAS |
| Condition | Scoliosis Idiopathic |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2024-07-18 |
| Primary Completion | 2033-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2024-07-18 with a primary completion date of 2033-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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.
Contact & Investigator
Jason Bernard, MD
PRINCIPAL INVESTIGATOR
Saint George's Hospital, London
Frequently Asked Questions
Who can join the NCT05830825 clinical trial?
This trial is open to participants of all sexes, aged 0 Years or older, up to 30 Years, studying Scoliosis Idiopathic. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05830825 currently recruiting?
Yes, NCT05830825 is actively recruiting participants. Contact the research team at ClinicalEMEA@highridgemedical.com for enrollment information.
Where is the NCT05830825 trial being conducted?
This trial is being conducted at London, United Kingdom, Newcastle upon Tyne, United Kingdom, Southampton, United Kingdom.
Who is sponsoring the NCT05830825 clinical trial?
NCT05830825 is sponsored by LDR Médical SAS. The principal investigator is Jason Bernard, MD at Saint George's Hospital, London. The trial plans to enroll 100 participants.