UnknownNot Applicable

Evaluation of a Modern System to Allow for Growth in Children With Scoliosis Versus a Conventional Treatment

Switzerland, United Kingdom18 participantsStarted 2015-06

Plain-language summary

The foremost challenge when managing early onset scoliosis (curve deformity before the age of 10) is to prevent curve progression while maintaining growth of the spine. Current treatment options require repetitive interventions as the spine and the child grow. This study will compare two techniques of growth modulation: Standard dual growing rods versus the new Luqué Trolley screws Hypothesis: Patients treated with the DePuy Synthes TROLLEY system will undergo fewer re-operations after 3 years of follow-up (FU) than patients included in the comparison group

Who can participate

Age range

5 Years – 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: * Age 5 - 10 years * Diagnosis of Early Onset Scoliosis with any of the following etiologies: Idiopathic Congenital Neuromuscular Syndromic Mesenchymal \- Significant growth potential defined by any of the following: pre peek growth velocity bone age \< 10; open triradiate cartilage * An expected significant spinal deformity of more than 80 degrees at skeletal maturity * Signed informed consent as legally required (patient, parents, etc.) * Willingness and ability of the patient to participate in the clinical investigation including imaging and FU procedures * Willingness and ability of the parents to support the patient in his/her study participation * Ability of the patient and parents to understand the content of the patient information / informed consent form and participate in the clinical investigation * Signed informed consent by patient / parent(s) Exclusion Criteria: * Curve magnitude and rigidity: Cobb greater than 100 degrees or bends less than 50 degrees * Prior spinal surgery * Skeletal maturity * Any not medically managed severe systemic disease * Participation in any other medical device or medicinal product study within the previous month that could influence the results of the present 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.

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

Number of re-operations

Timeframe: 3 years FU

Trial details

NCT IDNCT01672749

SponsorAO Innovation Translation Center

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2023-02

View on ClinicalTrials.gov More Early Onset Scoliosis trials