Safety and Efficacy Study of Spinal Tethering

Exclusion Criteria

• •Patients with vertebral body staples at any level of their spine
• •---Specifically, vertebral body staples that span an intervertebral disc space and are implanted for fusionless correction of scoliosis
• •Patients with any spine surgery prior to their VBT procedure
• •Patients with any deformity correction surgery, on their Lenke 1 curve, after their VBT procedure
• •With the exception of tether re-tensioning
• •Patients with any vertebral bodies that were instrumented outside of a thoracoscopic or minithoracotomy approach in conjunction with their VBT procedure
• •Patients that have an orthotic prescribed and used to correct their Lenke 1 curve any time after their VBT procedure but before the 2 year primary endpoint
• •Patients who are pregnant
• •Patients unwilling to return for prospective follow-up visit(s)
• •Patients with major psychiatric disorders (as defined in DSM-5)
• •Patients with a history of substance abuse (as defined in DSM-5)
• •Patients who are wards of the court
• •Patients who are in an active drug or device trial that is more than minimal risk and where their participation in the trial would confound the measurements of the present study
• •Patients who are in a device trial for efficacy of a musculoskeletal device and where their participation in the trial would confound the measurements of the present study
• •Patients who are less than 30 days out from completion from another clinical trial of more than minimal risk or for safety and efficacy
• •Patients for whom the investigator deems unwilling/incapable of participating