Actively Recruiting
Post-market Clinical Follow-up Study of NEMOST V2 Growing Domino
Led by EUROS · Updated on 2026-02-11
140
Participants Needed
5
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the NEMOST spinal implant, a growth domino device designed for surgical treatment of progressive scoliosis in children. This study is a post-market surveillance clinical trial conducted by EUROS to collect both retrospective and prospective clinical and radiological data. The main goal is to monitor complications and performance of the NEMOST growth domino over a five-year postoperative period in children with progressive scoliosis. The study involves the use of the NEMOST V2 growing domino device during surgery to treat children aged 5 to 17 years with progressive scoliosis that requires surgical intervention. This is an interventional, non-randomized, and uncontrolled study enrolling approximately 140 patients. Participants will be followed for five years after surgery to assess safety and device performance. During the study, participants will be monitored through clinical evaluations and radiological assessments to track complication rates and scoliosis progression. Researchers will measure outcomes such as Cobb angle, pelvic obliquity, thoracic kyphosis, lumbar lordosis, spinal length, and respiratory function over five years. Patient-reported outcomes will be collected using the Early-Onset Scoliosis questionnaire. The total study participation involves regular follow-ups during the five-year postoperative period.
CONDITIONS
Brief Title
Post-market Clinical Follow-up Study of NEMOST V2
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children aged 5 to 17 years with idiopathic, congenital, neuromuscular, or syndromic progressive scoliosis
- Progressive spinal deformity not managed by orthopedic treatment and requiring primary surgical intervention
- Patient and their parents or legal guardians have been informed about participation in the study
You will not qualify if you...
- 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
- Spine previously instrumented or fused
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Single surgical procedure with immediate post-operative care
Participants undergo surgical implantation of the NEMOST V2 growing domino device to treat progressive scoliosis.
1 surgery and immediate recovery period
Duration - Up to 5 years
Participants are monitored after surgery to assess recovery and device performance over time.
Regular follow-up visits over 5 years
Trial Site Locations
Total: 5 locations
1
Hopital Lenval Nice
Nice, Provence-Alpes-Côte d'Azur Region, France, 06000
Actively Recruiting
2
CHU Pellegrin
Bordeaux, France
Actively Recruiting
3
Hospices Civils de Lyon
Lyon, France
Not Yet Recruiting
4
Hopital Armand Trousseau
Paris, France
Not Yet Recruiting
5
Hopital Necker
Paris, France
Not Yet Recruiting
Research Team
C
Célia Armanet, PHD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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