Post-market Clinical Follow-up Study of NEMOST V2
Recruiting now · Not applicable
Conditions studied: Scoliosis Neuromuscular, Scoliosis Idiopathic, Consent Forms
In brief
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.
Key facts
- Study ID
- NCT07403084
- Run by
- EUROS
- People needed
- 140
- Starts
- 2025-12-19
- Expected to finish
- 2033-12-19
- Last updated by the study team
- 2026-02-11
Who can join
Age: 5 and older, up to 17. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- Hopital Lenval Nice — Nice, Provence-Alpes-Côte d'Azur Region, France (enrolling)
- CHU Pellegrin — Bordeaux, France (enrolling)
- Hospices Civils de Lyon — Lyon, France
- Hopital Armand Trousseau — Paris, France
- Hopital Necker — Paris, France
Full record on ClinicalTrials.gov
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