NCT04441411 Non Fusion Surgery in Adolescent Idiopathic Scoliosis Patients
| NCT ID | NCT04441411 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) |
| Condition | Adolescent Idiopathic Scoliosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 18 participants |
| Start Date | 2020-06-01 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 18 participants in total. It began in 2020-06-01 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The primary objective of the study is to monitor the effectiveness of a minimal invasive non-fusion double rod bipolar posterior spinal implant (Nemost growing domino) to correct the scoliotic curve in growing patients suffering from progressive adolescent idiopathic scoliosis (AIS) who have failed conservative treatment.
Eligibility Criteria
Inclusion Criteria: * Adolescent idiopathic scoliosis ; * Primary Cobb angle greater than 30°; * Failed non-operative treatment defined as progression of the curve greater than 5° per year at any time; * Skeletally immature (Risser grade\* ≤2 and Skeletal age of hand and wrist X-rays ≤14y); * In girl, either pre-menarchal or post-menarchal by no more than 1 year; * Age over 10 years; * Non rigid curve; * All Lenke type; * No previous spine surgery. Exclusion Criteria: * Non-idiopathic scoliosis: musculoskeletal or neurologic conditions responsible for cause of the spine curvature (i.e. neuromuscular, congenital or syndromic scoliosis); * History of previous spine surgery; * Risser sign \>2; * Disease or deformity likely to affect the stability of the device (i.e. inadequate anatomy of pedicles, trauma or tumor in fixation region, severe osteoporosis, bone destruction or poor bone quality); * Non-reductible scoliosis; * Known allergy or intolerance to one of the device material; * Acute or chronic infections, local or systemic; * Absence or insufficience of covering tissues; * Pathological obesity.
Contact & Investigator
BJ Van Royen, MD, PhD
PRINCIPAL INVESTIGATOR
AmsterdamUMC
Frequently Asked Questions
Who can join the NCT04441411 clinical trial?
This trial is open to participants of all sexes, aged 10 Years or older, up to 17 Years, studying Adolescent Idiopathic Scoliosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04441411 currently recruiting?
Yes, NCT04441411 is actively recruiting participants. Contact the research team at bj.vanroyen@amsterdamumc.nl for enrollment information.
Where is the NCT04441411 trial being conducted?
This trial is being conducted at Amsterdam, Netherlands.
Who is sponsoring the NCT04441411 clinical trial?
NCT04441411 is sponsored by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA). The principal investigator is BJ Van Royen, MD, PhD at AmsterdamUMC. The trial plans to enroll 18 participants.