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

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

This study is testing the safety and benefits of The Tether™ device in patients with progressive idiopathic scoliosis to see how it helps them after spine surgery over five years.

Quick facts

• Study type: Observational
• Enrollment: 100 (estimated)
• Ages: 0 Years to 30 Years
• Sex: All
• Sponsor: Highridge Medical (Industry-sponsored)
• Locations: 3 sites (London and 2 other locations)
• Trial ID: NCT05830825 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates for this study are skeletally immature patients diagnosed with progressive idiopathic scoliosis who have not benefited from bracing.

Not a fit: Patients with prior spinal surgery at the treatment level or those who are skeletally mature will likely not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the long-term safety and effectiveness of The Tether™ device for treating scoliosis without fusion.

How similar studies have performed: While this approach is relatively novel, previous studies on vertebral body tethering have shown promising results in similar patient populations.

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.

Where this trial is running

London and 2 other locations

• 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

Conditions Scoliosis Idiopathic; Vertebral Body Tethering; Fusionless Spine Surgery