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Post-market Clinical Follow-up Study of NEMOST V2 Growing Domino

Status: Recruiting
Location: See all (5) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 5
Maximum Age: 17
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
CHU Pellegrin
RECRUITING
Bordeaux
Hospices Civils de Lyon
NOT_YET_RECRUITING
Lyon
Hopital Lenval Nice
RECRUITING
Nice
Hopital Armand Trousseau
NOT_YET_RECRUITING
Paris
Hopital Necker
NOT_YET_RECRUITING
Paris
Contact Information
Primary
Célia Armanet, PHD
carmanet@euros.fr
+330756848896
Time Frame
Start Date: 2025-12-19
Estimated Completion Date: 2033-12-19
Participants
Target number of participants: 140
Treatments
Experimental: NEMOST V2
Related Therapeutic Areas
Sponsors
Leads: EUROS

This content was sourced from clinicaltrials.gov