Observational study on The Tether™ device for scoliosis in the UK

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to gather data on the safety and potential benefits of The Tether™ device in patients with progressive idiopathic scoliosis, specifically those with Lenke Type 1 curves. Participants will undergo spine surgery involving the device and will be monitored for five years post-surgery through regular follow-up visits. The study will enroll patients over a 36-month period and will assess outcomes at various intervals to ensure comprehensive data collection.

Why it matters

Who can join: the full rules

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.

Where it's running

• Saint George's Hospital
  London, United Kingdom Recruiting
• Freeman Hospital
  Newcastle upon Tyne, United Kingdom Recruiting
• University Southampton Hospital
  Southampton, United Kingdom Recruiting

Study contacts

• Principal investigator: Jason Bernard, MD — Saint George's Hospital, London
• Study coordinator: Delphine Lebrasseur-Longuet
• Email: ClinicalEMEA@highridgemedical.com
• Phone: +33 626262240

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.