Post-market follow-up of the NEMOST V2 spinal implant

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, non-randomized post-market surveillance will collect retrospective and prospective clinical and radiological data on 140 children treated with the NEMOST V2 growing domino for progressive scoliosis. Participants aged 5–17 with idiopathic, congenital, neuromuscular, or syndromic scoliosis requiring primary surgical intervention will be enrolled at three French centers. The study is interventional but uncontrolled, and follows patients for five years after surgery to record complications (primary objective) and device performance (secondary objective). Clinical exams and imaging at scheduled postoperative intervals will be used to characterize safety events and the long-term behavior of the implant.

Why it matters

Who can join: the full rules

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.

Where it's running

• Hopital Lenval Nice
  Nice, Provence-Alpes-Côte d'Azur Region, 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 contacts

• Principal investigator: Federico Solla, MD — Centre Hospitalier Universitaire de Nice
• Study coordinator: Célia Armanet, PHD
• Email: carmanet@euros.fr
• Phone: +330756848896

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• High-resolution MRI of paravertebral (back) muscles in children with idiopathic or neuromuscular scoliosis

  We will use a short, extra high-resolution MRI to see if differences in the deep back muscles are linked to scoliosis in children aged 10–17 with idiopathic or neuromuscular forms.

  Recruiting Assistance Publique - Hôpitaux de Paris · Garches · NCT07135765

• TXA in kids undergoing scoliosis surgery

  This trial tests whether tranexamic acid can reduce blood loss and the need for transfusions in children aged 10–18 having surgery for idiopathic scoliosis.

  Recruiting Poznan University of Medical Sciences · Poznan · NCT07581457

• Diffusion in the growing spine: ADC of the intervertebral disc in children

  This study tests whether MRI diffusion measurements in the intervertebral disc can help understand differences between scoliotic and healthy children.

  Recruiting University Hospital, Limoges · Limoges and 1 other locations · NCT07331298

• Preoperative IV iron for teens having spinal fusion to correct scoliosis

  This trial will try giving a single IV iron infusion before spinal fusion to see if it helps 10–19-year-olds with scoliosis and low iron by reducing blood transfusions and improving recovery.

  Recruiting Phase 2/3 Columbia University · New York, New York · NCT07217873

• Breathing muscle training for children and teens with idiopathic scoliosis during Schroth therapy

  This project will see if adding inspiratory muscle training to Schroth therapy helps 11–16-year-olds with idiopathic scoliosis breathe better, tolerate exercise more, and strengthen their core.

  Recruiting at 2 sites Wroclaw University of Health and Sport Sciences · Wroclaw, Lower Silesian Voivodeship and 1 other locations · NCT07177430

• Schroth method with and without core stabilization exercises for adolescents with idiopathic scoliosis

  This trial tests whether adding core stabilization exercises to the Schroth method helps teens (ages 10–18) with mild idiopathic scoliosis reduce spinal curve, build back endurance, increase chest mobility, and improve quality of life.

  Recruiting University of Lahore · Lahore, Punjab Province · NCT07059663

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.