Post-market Clinical Follow-up Study of NEMOST V2

Post-market Clinical Follow-up Study of NEMOST V2 Growing Domino

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.

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.