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Post-market Clinical Follow-up Study of NEMOST V2

RecruitingNAAges 5 Years - 17 YearsAllEUROS
NCT07403084 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The NEMOST spinal implant is a growth domino intended for the surgical treatment of progressive scoliosis in children. As part of post-market surveillance, EUROS is conducting a retrospective and prospective study to collect clinical and radiological data on the NEMOST growth domino. Retrospective and prospective multicenter post-market surveillance clinical study. This study is interventional, non-randomized, and uncontrolled. The primary objective of this clinical study is to monitor complications related to the NEMOST growth domino during a 5-year postoperative follow-up in patients treated for progressive scoliosis in children. The secondary objective of this clinical study is to monitor the performance of the NEMOST growth domino during a 5-year postoperative follow-up in patients treated for progressive scoliosis in children. The study will include 140 patients.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Idiopathic, congenital, neuromuscular, or syndromic scoliosis : Progressive spinal deformity not managed by orthopedic treatment, and requiring primary surgical intervention. * The patient, as well as their parents or legal guardians, are informed of the participation in the study. * Patients aged from 5 to 17 yeas old, excepted the one who still have a potential for growth Exclusion Criteria: * signs of local inflammation; * acute or chronic, local or systemic infections ; * non-reducible scoliosis ; * pathological obesity ; * allergy or intolerance to implanted materials; * insufficiency or absence of tissue coverage. The NEMOST implant should not be used in a spine that has already been instrumented or fused.
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What it tests

  • NEMOST V2 growing domino
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Where

5 sites
Hopital Lenval Nice
Nice, France
CHU Pellegrin
Bordeaux, France
Hospices Civils de Lyon
Lyon, France
Hopital Armand Trousseau
Paris, France
Hopital Necker
Paris, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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