Scoliosis NeuromuscularNEMOST V2NCT07403084
Post-market Clinical Follow-up Study of NEMOST V2
A study testing NEMOST V2 growing domino in people with Scoliosis Neuromuscular and Scoliosis Idiopathic, run by EUROS at 5 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 17 years
- Conditions the study is for
- Scoliosis Neuromuscular, Scoliosis Idiopathic, Consent Forms
- What is being tested?
- NEMOST V2 growing domino
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 5 sitesFrance
- Study dates
- 19 Dec 2025to 19 Dec 2033
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
France5 sites, 5 recruiting
- Recruiting
CHU Pellegrin
Bordeaux
Louis Boissière, 0535544142, louis.boissiere@chu-bordeaux.fr
Louis Boissière
- Not yet recruiting
Hospices Civils de Lyon
Lyon
Vincent Cunin, 04 27 85 57 95, vincent.cunin@chu-lyon.fr
Vincent Cunin
- Recruiting
Hopital Lenval Nice
Nice, Provence-Alpes-Côte d'Azur Region, 06000
Federico Solla, 0492030491, federico.solla@hpu.lenval.com
Federico Solla
- Not yet recruiting
Hopital Armand Trousseau
Paris
Raphael Vialle, 0144736125, raphael.vialle@aphp.fr
Raphael Vialle
- Not yet recruiting
Hopital Necker
Paris
Lotfi Miladi, +33171196282, l.miladi@aphp.fr
Lotfi Miladi
About this study
Official title: 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.
Read more
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
- Being tested
- NEMOST V2 growing domino
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NEMOST V2 growing dominoDevice
The NEMOST spinal implant is a growth domino intended for the surgical treatment of progressive scoliosis in children.
| Study group | Role | What they receive |
|---|---|---|
| NEMOST V2 | Experimental | Not described Receives: Device: NEMOST V2 growing domino |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complication rate
The safety of the device will be studied by monitoring all complications, reinterventions and revisions.
Measured: 5 years
Secondary outcomes (7)
Cobb angle (°)
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.
Measured: 5 years
Early-Onset Scoliosis questionnaire 24 items (EOSQ-24)
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.
Measured: 5 years
Pelvic obliquity (°)
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.
Measured: 5 years
Thoracic kyphosis (°)
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.
Measured: 5 years
Lumbar lordosis (°)
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°.
Measured: 5 years
T1-T12 and T1-S1 length (mm)
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.
Measured: 5 years
Respiratory functional exploration
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.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2026
- Study start19 Dec 2025
- Primary completion19 Dec 2033 (estimated)
- Study completion19 Dec 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Scoliosis NeuromuscularStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- EUROS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Federico Solla, MD, Principal investigator, Centre Hospitalier Universitaire de Nice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07403084
- Sponsor's protocol ID
- EC-304-02
- Acronym
- NEMOST V2
- Status last verified
- Feb 2026
- First submitted
- 28 Jan 2026
- Last updated
- 11 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-market Clinical Follow-up Study of NEMOST V2 Growing Domino
- ClinicalTrials.gov ID
- NCT07403084
- Acronym / sponsor ID
- NEMOST V2 / EC-304-02
- Conditions
- Scoliosis Neuromuscular, Scoliosis Idiopathic, Consent Forms
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- EUROSIndustry (pharma, biotech, devices)
- Study start
- 19 Dec 2025 (actual)
- Primary completion
- 19 Dec 2033 (estimated)
- Study completion
- 19 Dec 2033 (estimated)
- First posted
- 11 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NEMOST V2 | Experimental | Device: NEMOST V2 growing domino |
Who may qualify
- Ages
- 5 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- signs of local inflammation;
- acute or chronic, local or systemic infections ;
- non-reducible scoliosis ;
- pathological obesity ;
- allergy or intolerance to implanted materials;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NEMOST V2 growing dominoThe NEMOST spinal implant is a growth domino intended for the surgical treatment of progressive scoliosis in children. | Device | NEMOST V2 |
Primary outcome
Complication rate
Time frame: 5 years
The safety of the device will be studied by monitoring all complications, reinterventions and revisions.
7 secondary outcomes
Cobb angle (°)
Time frame: 5 years
Early-Onset Scoliosis questionnaire 24 items (EOSQ-24)
Time frame: 5 years
Pelvic obliquity (°)
Time frame: 5 years
Thoracic kyphosis (°)
Time frame: 5 years
Lumbar lordosis (°)
Time frame: 5 years
T1-T12 and T1-S1 length (mm)
Time frame: 5 years
Respiratory functional exploration
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Federico Solla, MD principal investigator
Centre Hospitalier Universitaire de Nice
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NEMOST V2 growing domino in people with Scoliosis Neuromuscular and Scoliosis Idiopathic, run by EUROS at 5 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Célia Armanet, PHD (+330756848896, carmanet@euros.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complication rate (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2026.