Surgical Treatment of Progressive Scoliosis With "NEMOST" Growing Rod
Surgical Treatment of Progressive Scoliosis With "NEMOST" Growing Rod
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 of this study is to evaluate the performance of the growing device "NEMOST"
 associated to physiotherapy at 12 months postoperatively in patients treated for progressive
 scoliosis and to evaluate its safety.
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 graft called "growing rods". The use of growing rods in patients with
 progressive scoliosis requires several repeated surgeries (every 6 to 12 months) in order to
 follow the growth of children. These repeated surgeries lead to a significant increased risk
 of complications, that's why many teams around the world have been seeking solutions which
 allow to obtain a rod expansion without repeated surgery.

 The purpose of our study is the evaluation of the use of medical device that will perform the
 correction of scoliosis and, at the same time, preserve the growth of the child's spine. In
 addition, the purpose of clinical investigation is to test the theory that distraction effort
 may be exercised without surgery thanks to traction manoeuvres and physiotherapy. This could
 allow to obtain in patients with progressive scoliosis, correction of spinal deformity while
 avoiding many repeated surgeries. Our reference device is growing rod "NEMOST". When
 implanted, NEMOST rod is immediately turned on, for correcting and maintaining the correction
 of spinal deformity. After implantation, depending on development in Cobb angle, one or more
 elongations can be made by sliding the notched portion of the rod in its tunnel by a
 distraction effort (traction equipments and physiotherapy).

 Therefore, the growth device NEMOST will allow to continue, on request, the correction of
 spinal deformity by performing a distraction by external manoeuvres on the notched part
 without the need for surgery.
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.