Post-market Clinical Follow-up Study of NEMOST V2
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age5-17
SponsorEUROS
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
signs of local inflammation;
acute or chronic, local or systemic infections ;
non-reducible scoliosis ;
pathological obesity ;
Trial design
Treatments tested in this trial
- NEMOST V2 growing domino
Treatment groups
140 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov