Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2025-12-25 @ 12:32 AM
NCT ID:
NCT02266667
Eligibility Criteria:
Inclusion Criteria:
* Patient from 5 to 15 years old
* Patient with neuromuscular scoliosis or progressive scoliosis resistant to conservative treatment
* Patient with an indication of first-line surgery without graft
* Patient with low skeletal maturity (Risser test = 0 and triradiate growth cartilages still open)
* Signing of the consent by the holder (s) of parental authority and the investigator
* Affiliated patient to a health service or entitled patient
Exclusion Criteria:
* Patient with a history of spinal surgery
* Patient weighing more than 30 kg and with progressive scoliosis other than neuromuscular
* Patient with contra-indication to Nemost device, that is to say:
* Inflammation or acute Infection, local or systemic,
* Allergy or intolerance titanium or polyetheretherketone,
* Pathology or poor bone quality might compromise the attachment of the device,
* Nonreducible Scoliosis,
* Skin Substance insufficient to cover the wound,
* Pathological Obesity,
* Fracture and / or spinal tumor,
* Patient whose behavior presents a risk of failure for the device.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
5 Years
Maximum Age:
15 Years
Study:
NCT02266667
Study Brief:
Protocol Section:
NCT02266667