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Recruiting NCT07403084

NCT07403084 Post-market Clinical Follow-up Study of NEMOST V2

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Clinical Trial Summary
NCT ID NCT07403084
Status Recruiting
Phase
Sponsor EUROS
Condition Scoliosis Neuromuscular
Study Type INTERVENTIONAL
Enrollment 140 participants
Start Date 2025-12-19
Primary Completion 2033-12-19

Eligibility & Interventions

Sex All sexes
Min Age 5 Years
Max Age 17 Years
Study Type INTERVENTIONAL
Interventions
NEMOST V2 growing domino

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 140 participants in total. It began in 2025-12-19 with a primary completion date of 2033-12-19.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

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.

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.

Contact & Investigator

Central Contact

Célia Armanet, PHD

✉ carmanet@euros.fr

📞 +330756848896

Principal Investigator

Federico Solla, MD

PRINCIPAL INVESTIGATOR

Centre Hospitalier Universitaire de Nice

Frequently Asked Questions

Who can join the NCT07403084 clinical trial?

This trial is open to participants of all sexes, aged 5 Years or older, up to 17 Years, studying Scoliosis Neuromuscular. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT07403084 currently recruiting?

Yes, NCT07403084 is actively recruiting participants. Contact the research team at carmanet@euros.fr for enrollment information.

Where is the NCT07403084 trial being conducted?

This trial is being conducted at Nice, France, Bordeaux, France, Lyon, France, Paris, France and 1 additional location.

Who is sponsoring the NCT07403084 clinical trial?

NCT07403084 is sponsored by EUROS. The principal investigator is Federico Solla, MD at Centre Hospitalier Universitaire de Nice. The trial plans to enroll 140 participants.

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