Post-market Clinical Follow-up Study of NEMOST V2 (NEMOST V2)

February 4, 2026 updated by: EUROS

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

140

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Bordeaux, France
        • Recruiting
        • CHU Pellegrin
        • Contact:
        • Principal Investigator:
          • Louis Boissière
        • Sub-Investigator:
          • Yan Lefèvre
      • Lyon, France
        • Not yet recruiting
        • Hospices Civils de Lyon
        • Contact:
        • Principal Investigator:
          • Vincent Cunin
      • Paris, France
        • Not yet recruiting
        • Hopital Necker
        • Contact:
        • Principal Investigator:
          • Lotfi Miladi
      • Paris, France
        • Not yet recruiting
        • Hôpital Armand Trousseau
        • Contact:
        • Principal Investigator:
          • Raphael Vialle
        • Sub-Investigator:
          • Mathilde Gaumé
    • Provence-Alpes-Côte d'Azur Region
      • Nice, Provence-Alpes-Côte d'Azur Region, France, 06000
        • Recruiting
        • Hopital Lenval Nice
        • Contact:
        • Principal Investigator:
          • Federico Solla

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: NEMOST V2
Device: NEMOST V2 growing domino
The NEMOST spinal implant is a growth domino intended for the surgical treatment of progressive scoliosis in children.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complication rate
Time Frame: 5 years
The safety of the device will be studied by monitoring all complications, reinterventions and revisions.
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cobb angle (°)
Time Frame: 5 years

Comparison between preoperative measures, immediate postoperative measures and each visit measures.

Measured on seated or standing anteroposterior and lateral X-ray images by identifying the most tilted vertebrae at the top and bottom of the spinal curve, drawing lines along their endplates, and calculating the angle formed by the intersection of perpendiculars to these lines. Normal value for Cobb angle is <10° for no or benign scoliosis, medium scoliosis is defined between 15 and 35°, important scoliosis is defined as between 35 and 60° and very important scoliosis corresponds to angle > 65°. The Cobb angle correction, used to compare pre and postoperative angle is defined as 100*(preoperative value - postoperative value) / postoperative value.
5 years
Early-Onset Scoliosis questionnaire 24 items (EOSQ-24)
Time Frame: 5 years

Considering clinical evaluation, the EOSQ-24 auto questionnaire addressed to patients' parents was selected. The 24-Item Early-onset Scoliosis Questionnaire (EOSQ-24) is a locally validated measurement tool to evaluate the overall impact of early onset scoliosis on patients' physical, psychological, and socio-economic well-being. Clinical results are assessed thanks to the EOSQ-24 quality of life questionnaire. It is divided in 11 themes, for which a score is calculated over 100. Each item is composed of 1 to 5 questions rated from 1 to 5, 5 being the best score. These scores will be between 0 to 100.

Comparison between preoperative measures, immediate postoperative measures and each visit measures.
5 years
Pelvic obliquity (°)
Time Frame: 5 years

Measured on seated or standing anteroposterior and lateral X-ray images by drawing a line between the iliac crests (or the inferior aspects of the sacroiliac joints) and calculating the angle between this line and a horizontal reference line. Normal value is 0°.

Comparison between preoperative measures, immediate postoperative measures and each visit measures.
5 years
Thoracic kyphosis (°)
Time Frame: 5 years

Measured on seated or standing anteroposterior and lateral X-ray images by calculating the Cobb angle between the superior endplate of the upper thoracic vertebra and the inferior endplate of the lower thoracic vertebra defining the kyphotic curve (commonly T4-T12).

Comparison between preoperative measures, immediate postoperative measures and each visit measures.
5 years
Lumbar lordosis (°)
Time Frame: 5 years

Measured on seated or standing anteroposterior and lateral X-ray images by calculating the Cobb angle between the superior endplate of the upper lumbar vertebra and the superior endplate of the sacrum (commonly L1-S1).

Comparison between preoperative measures, immediate postoperative measures and each visit measures.

Normal value ranges from 20 to 60°.
5 years
T1-T12 and T1-S1 length (mm)
Time Frame: 5 years

T1-T12 length is measured on a standing or seated anteroposterior spinal radiograph as the linear distance between the midpoint of the superior endplate of T1 and the midpoint of the inferior endplate of T12.

T1-S1 length is measured on a standing or seated anteroposterior spinal radiograph as the linear distance between the midpoint of the superior endplate of T1 and the midpoint of the superior endplate of S1.

Comparison between preoperative measures, immediate postoperative measures and each visit measures.
5 years
Respiratory functional exploration
Time Frame: 5 years

Pulmonary function testing is performed in a seated or supine position by measuring Total Lung Capacity (TLC, mL) and Vital Capacity (VC, mL) using standardized pulmonary function tests.

Comparison between preoperative measures and each visit measures.
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

EUROS

Investigators

  • Principal Investigator: Federico Solla, MD, CHU Nice

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 19, 2025

Primary Completion (Estimated)

December 19, 2033

Study Completion (Estimated)

December 19, 2033

Study Registration Dates

First Submitted

January 28, 2026

First Submitted That Met QC Criteria

February 4, 2026

First Posted (Actual)

February 11, 2026

Study Record Updates

Last Update Posted (Actual)

February 11, 2026

Last Update Submitted That Met QC Criteria

February 4, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • EC-304-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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