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Non Fusion Surgery in Adolescent Idiopathic Scoliosis Patients

RecruitingNAAges 10 Years - 17 YearsAllAcademisch Medisch Centrum - Universiteit van Amsโ€ฆ
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Adolescent idiopathic scoliosis ; * Primary Cobb angle greater than 30ยฐ; * Failed non-operative treatment defined as progression of the curve greater than 5ยฐ per year at any time; * Skeletally immature (Risser grade\* โ‰ค2 and Skeletal age of hand and wrist X-rays โ‰ค14y); * 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.
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What it tests

  • NEMOST system
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Where

1 site
AmsterdamUMC, location AMC
Amsterdam, Netherlands
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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