Post-market Clinical Follow-up Study of NEMOST V2

NCT07403084 | Recruiting

• 1 other identifier: EC-304-02
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Scoliosis Neuromuscular; Scoliosis Idiopathic; Consent Forms

Outcome Measures

Primary Outcomes (1)

• Complication rate

  The safety of the device will be studied by monitoring all complications, reinterventions and revisions.

  5 years

Secondary Outcomes (7)

• Cobb angle (°)

  5 years

• Early-Onset Scoliosis questionnaire 24 items (EOSQ-24)

  5 years

• Pelvic obliquity (°)

  5 years

• Thoracic kyphosis (°)

  5 years

• Lumbar lordosis (°)

  5 years

Study Arms (1)

NEMOST V2

EXPERIMENTAL

Device: NEMOST V2 growing domino

Interventions

NEMOST V2 growing domino DEVICE

The NEMOST spinal implant is a growth domino intended for the surgical treatment of progressive scoliosis in children.

NEMOST V2

Eligibility Criteria

• Age: 5 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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.

Sponsors & Collaborators

• EUROS: lead

Study Sites (5)

Hopital Lenval Nice

Nice, Provence-Alpes-Côte d'Azur Region, 06000, 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 Officials

• Federico Solla, MD

  CHU NICE

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Célia Armanet, PHD

CONTACT

+330756848896; carmanet@euros.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2026
• First Posted: February 11, 2026
• Study Start: December 19, 2025
• Primary Completion (Estimated): December 19, 2033
• Study Completion (Estimated): December 19, 2033
• Last Updated: February 11, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (5)