Post-market Clinical Follow-up Study of NEMOST V2
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: NEMOST V2 growing domino.
- Who it may be relevant to
- Registry conditions: Scoliosis Neuromuscular, Scoliosis Idiopathic, Consent Forms. Basic parameters: 5 years — 17 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Post-market Clinical Follow-up Study of NEMOST V2 Growing Domino
Overview
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.
Interventions
- Device NEMOST V2 growing domino
The NEMOST spinal implant is a growth domino intended for the surgical treatment of progressive scoliosis in children.
Primary outcome measures
- Complication rate [Time frame: 5 years]
Secondary outcome measures (7)
- 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]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
France · 5 centers
- Hopital Lenval Nice — Nice
- CHU Pellegrin — Bordeaux
- Hospices Civils de Lyon — Lyon
- Hopital Armand Trousseau — Paris
- Hopital Necker — Paris
Identifiers
NCT: NCT07403084 · EC-304-02