Limited-efficacy Testing of SDS and NEMOST for Early Onset Neuromuscular Scoliosis (NCT04021784) | Clinical Trial Compass
CompletedNot Applicable
Limited-efficacy Testing of SDS and NEMOST for Early Onset Neuromuscular Scoliosis
Netherlands28 participantsStarted 2019-05-06
Plain-language summary
The primary aim of this study is to investigate and describe the limited efficacy of the Spring Distraction System (SDS) and Bilateral One Way Rod (NEMOST) in maintaining curve reduction without repeat lengthening procedures and complications.
Secondary aims are to describe growth of the instrumented spine, health-related quality of life, and to compare both devices.
Who can participate
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:
* Non ambulant
* Neuromuscular or syndromal scoliosis
* Progressive scoliosis indicated for bipolar fixation extending to the pelvis
* Diagnosis of scoliosis before age 10
* Patient under 12 and open triradiate cartilage (usually closes around 12 years for girls and 14 years for boys)
* Main curve proximal end vertebra below Th 3
* Non rigid curve
* Patients who have an indication for a primary surgery
Exclusion Criteria:
* Ambulant
* Patients with closed triradiate cartilage
* Patients with a skeletal dysplasia that effects growth (Achondroplasia, SED)
* Patients with a systemic disease which severely influences bone quality e.g. osteogenesis imperfecta, metabolic diseases
* Patients with soft tissue weakness (Ehler Danlos, Marfan, Neurofibromatosis, Prader Willi)
* Patients that have a congenital anomaly of the spine of more than 5 vertebrae
* Patients with an active systemic disease such as JIA, HIV, oncologic treatment
* Patients with a previous surgical fusion of the spine
* Patients that are expected to be lost to FU due to e.g. likely to immigrate within 1 year.
* Patients that have had a previous spine surgery.
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
Limited-efficacy of SDS and NEMOST in terms of curve correction maintenance
Timeframe: Until 1 year post-operatively
2
Incidence of possible Treatment-Emergent Serious Adverse Events of SDS and NEMOST