VEPTR Implantation to Treat Children With Early Onset Scoliosis Without Rib Abnormalities (NCT00689533) | Clinical Trial Compass
UnknownNot Applicable
VEPTR Implantation to Treat Children With Early Onset Scoliosis Without Rib Abnormalities
United States250 participantsStarted 2008-01
Plain-language summary
Primary Objective: To evaluate the use of unilateral or bilateral VEPTR devices, with or without expansion thoracoplasty, for preventing further progression of the Cobb angle, allowing for spinal growth and improving pulmonary function in the treatment of children with progressive scoliosis without rib abnormalities.
Who can participate
Age range
18 Months – 10 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:
* Progressive scoliosis: idiopathic, congenital, syndromic, neuromuscular
* Progressive scoliosis with a Cobb angle that has advanced beyond 45˚
* 18 months to 10 years of age with open triradiate cartilages
Exclusion Criteria:
* Presence of fused ribs
* Presence of multiple absent ribs
* Thoracic dysplasia such as Jeune's syndrome or equivalent condition
* Prior spinal fusion or spinal instrumentation
* Patient is participating in another clinical trial using investigational devices/drugs
* Patient is unable or unwilling to sign a consent form
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
The patient's Cobb angle at the final surgery is less than or equal to the patient's pre-operative Cobb angle
Timeframe: Anticipate 6 years
2
The patient's trunk height or spinal length at final surgery is greater than or equal to the patient's immediate post-operative trunk height or spinal length