Post-market follow-up of the NEMOST V2 spinal implant

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

This project will try the NEMOST V2 growing domino in children aged 5–17 with progressive scoliosis to track safety and device performance over five years.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 140 (estimated)
• Ages: 5 Years to 17 Years
• Sex: All
• Sponsor: Euros (Industry-sponsored)
• Locations: 5 sites (Nice, Provence-Alpes-Côte d'Azur Region and 4 other locations)
• Trial ID: NCT07403084 on ClinicalTrials.gov

What this trial studies

This multicenter, non-randomized post-market surveillance will collect retrospective and prospective clinical and radiological data on 140 children treated with the NEMOST V2 growing domino for progressive scoliosis. Participants aged 5–17 with idiopathic, congenital, neuromuscular, or syndromic scoliosis requiring primary surgical intervention will be enrolled at three French centers. The study is interventional but uncontrolled, and follows patients for five years after surgery to record complications (primary objective) and device performance (secondary objective). Clinical exams and imaging at scheduled postoperative intervals will be used to characterize safety events and the long-term behavior of the implant.

Who should consider this trial

Good fit: Children aged 5–17 with progressive idiopathic, congenital, neuromuscular, or syndromic scoliosis who require primary surgical intervention and whose parents or guardians consent.

Not a fit: Patients with local inflammation or active infection, pathological obesity, non-reducible scoliosis, allergy to implant materials, insufficient tissue coverage, or prior spinal instrumentation/fusion are unlikely to benefit from this implant.

Why it matters

Potential benefit: If successful, the study could confirm that NEMOST V2 controls spinal curvature while allowing growth and has an acceptable safety profile, potentially reducing the need for additional procedures.

How similar studies have performed: Other growth-friendly spinal devices (growing rods, VEPTR, magnetically controlled rods) have shown mixed success with known complication profiles, while NEMOST-specific long-term data remain limited beyond its market release.

Eligibility criteria

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.

Where this trial is running

Nice, Provence-Alpes-Côte d'Azur Region and 4 other locations

• Hopital Lenval Nice — Nice, Provence-Alpes-Côte d'Azur Region, France (Recruiting)
• CHU Pellegrin — Bordeaux, France (Recruiting)
• Hospices Civils de Lyon — Lyon, France (Not_yet_recruiting)
• Hopital Armand Trousseau — Paris, France (Not_yet_recruiting)
• Hopital Necker — Paris, France (Not_yet_recruiting)

Study contacts

• Principal investigator: Federico Solla, MD — Centre Hospitalier Universitaire de Nice
• Study coordinator: Célia Armanet, PHD

Conditions Scoliosis Neuromuscular; Scoliosis Idiopathic; Consent Forms