Progressive Scoliosis Clinical Trial
Official title:
Evaluation of the Efficiency of Nemost Growing Spine Device Associated With Physiotherapy in the Surgical Treatment of Progressive Scoliosis of the Child
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.
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