Vertebral Body Tethering Treatment for Idiopathic Scoliosis (NCT03802656) | Clinical Trial Compass
TerminatedNot Applicable
Vertebral Body Tethering Treatment for Idiopathic Scoliosis
Stopped: Device is no longer investigational. It has been approved by the FDA as an HUD under HDE H190005.
United States2 participantsStarted 2019-06-24
Plain-language summary
This study will determine whether vertebral body tethering is a safe and feasible method of treatment for pediatric idiopathic scoliosis.
Who can participate
Age range
8 Years – 16 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Males or females age 8 to 16 years old at time of enrollment (inclusive)
. Diagnosis of idiopathic scoliosis
. Sanders bone age of less than or equal to 4
. Thoracic or thoracolumbar/lumbar curves of greater than or equal to 35 degrees and less than or equal to 60 degrees from levels T4 through L3
. Lenke classification of 1, 2, 3, 5, or 6
. Patient has already been identified for and recommended to have surgical intervention
. Spina bifida occulta is permitted
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Safety: Incidence of Treatment-Emergent Adverse Events
Timeframe: 2 years after last subject's device implantation
. Spondylolysis or Spondylolisthesis is permitted, as long as it is non-operative, the patient has not had any previous surgery for this, and no surgery is planned in the future
Exclusion criteria
. Pregnancy (current)
. Prior spinal or chest surgery
. MRI abnormalities (including syrinx greater than 4mm, Chiari malformation, or tethered cord)
. Neuromuscular, thoracogenic, cardiogenic scoliosis, or any other non-idiopathic scoliosis
. Associated syndrome, including Marfan Disease or Neurofibromatosis
. Sanders bone age greater than 4
. Thoracic or thoracolumbar/lumbar curves less than 35 degrees or greater than 60 degrees
. Compensatory curve greater than 35 degrees without intent to treat surgically