Status:
COMPLETED
Surgical Treatment of Progressive Scoliosis With "NEMOST" Growing Rod
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsors:
Company EUROS
URC-CIC Paris Descartes Necker Cochin
Conditions:
Progressive Scoliosis
Eligibility:
All Genders
5-15 years
Phase:
NA
Brief Summary
The purpose of this study is to evaluate the performance of the device "NEMOST" on maintaining of the correction of the scoliosis with growth preservation and avoiding iterative surgeries. Objective ...
Detailed Description
A number of scoliosis in the child remain progressive despite conservative treatment well conducted. Nowadays the most used treatment is early surgical treatment by the spinal instrumentation without ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 11 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 15 2019
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT02266667
Start Date
April 11 2016
End Date
May 15 2019
Last Update
September 8 2025
Active Locations (1)
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1
Hospital Necker Enfants Malades
Paris, France, 75015