The Treatment of Progressive Early Onset Spinal Deformities: A Multi-Center Outcome Study (NCT02299362) | Clinical Trial Compass
CompletedNot Applicable
The Treatment of Progressive Early Onset Spinal Deformities: A Multi-Center Outcome Study
United States, Canada, Egypt2,602 participantsStarted 2008-10
Plain-language summary
The purpose of this study is to examine the treatment, both surgical and non-surgical, of patients with any form of early onset scoliosis. Such treatment may include the use of growth friendly devices that are surgically or magnetically lengthened; or the use of serial body casting or bracing, or observation. Outcomes examined will be what can be seen physically on the patient and on x-ray, as well as parent perception of how the treatment effects their child with the use of a health-related quality of life (HRQOL) questionnaire.
Who can participate
Age range
1 Day – 18 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:
* Patients of any age and any diagnosis who undergo a growth-friendly surgical procedure, including but not limited to growing rods, VEPTR, Shilla, hybrid constructs, spinal tethering and staples
* Patients of any age and any diagnosis who undergo casting
* Patients of any diagnosis 10 years of age and younger who undergo spinal fusion of the thoracic and/or lumbar spine
* Patients of any diagnosis under 6 years of age with scoliosis curves of the thoracic and/or lumbar spine measuring \> 25 degrees. Observed and braced patients included
Exclusion Criteria:
* Cervical spine anomalies alone will not be included
* Patient/family is unwilling to participate in the study
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.
1This study tracked clinical and radiographic outcomes for children with early onset scoliosis and related conditions — what were the key findings, and do the results change how you'd recommend treating my child's specific type of spinal deformity?
2Since this was a multi-center observational study rather than a trial testing a new treatment, does it tell us anything meaningful about the long-term risks or benefits of the approaches my child might undergo, like growing rods or other interventions for early onset scoliosis?
3My child has been diagnosed with a specific type — such as congenital or neuromuscular spinal deformity — and this study grouped several different diagnoses together; does the data from this registry apply equally to my child's condition, or are some groups better represented than others?
4Now that this study is completed, are there published results I can review with you, and do those results suggest any particular treatment path tends to work better for children at my child's stage of progression?
5Given that thoracic insufficiency syndrome is one of the conditions studied here, how do we weigh the risk of breathing problems against the timing and type of spinal intervention you're recommending for my child?
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.