The Tether™ - Vertebral Body Tethering System Post Approval Study

Launched by ZIMVIE · Aug 5, 2020

Keywords

ClinConnect Summary

The Tether™ - Vertebral Body Tethering System Post Approval Study is a clinical trial designed to gather important information about the safety and effectiveness of a treatment for idiopathic scoliosis, a condition where the spine curves abnormally. This study will focus on patients who have had a specific type of surgery called anterior vertebral body tethering (AVBT) using The Tether system. By collecting long-term data from these patients, researchers hope to confirm that this treatment is safe and beneficial for managing scoliosis.

To participate in this study, potential candidates must have progressive idiopathic scoliosis and be skeletally immature, meaning their bones are still growing. Specifically, they should have a curve in their spine that measures between 30° and 65° and have not found relief with bracing. Participants will need to attend follow-up visits to monitor their progress after surgery and must be willing to sign consent forms to join the study. This trial is currently recruiting participants of all ages and genders, and it aims to provide valuable insights for those affected by scoliosis.

Gender

ALL

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 or intolerant to bracing
• 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
• • Documented poor bone quality, defined as a T-score -1.5 or less
• • 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 patient's 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
• • Unwillingness to sign Informed Consent Form and participate in study procedures