Surgical Treatment of Progressive Scoliosis With NEMOST Growing Rod

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Evaluation of the Efficiency of Nemost Growing Spine Device Associated With Physiotherapy in the Surgical Treatment of Progressive Scoliosis of the Child

Conditions
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Progressive Scoliosis

Intervention / Treatment
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* Device: 2 NEMOST rods : bilateral vertebral-pelvic implantation
* Device: 1 NEMOST rod :unilateral vertebral-pelvic implantation


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Progressive scoliosis<br>Children with progressive scoliosis | Device: 1 NEMOST rod :unilateral vertebral-pelvic implantation<br>* Implantation of one NEMOST rod (unilateral vertebral-pelvic implantation)<br>|
| Experimental: Neuromuscular scoliosis<br>Children with neuromuscular scoliosis | Device: 2 NEMOST rods : bilateral vertebral-pelvic implantation<br>* Implantation of two NEMOST rods (bilateral vertebral-pelvic implantation)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| No surgical reoperation | The lack of indication of surgical reoperations means that the correction of scoliosis is satisfactory and the growth had been maintained | 12 months | 
| No worsening of Cobb angle by more than 15 degrees since the initial correction | A worsening of the Cobb angle by more than 15 ° since the initial correction is considered an indication of reoperation | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cobb angle | Radiographic measure : less than 15 degrees since the initial correction | 3 months | 
| Cobb angle | Radiographic measure : less than 15 degrees since the initial correction | 6 months | 
| Cobb angle (degree) | Radiographic measure : less than 15 degrees since the initial correction | 18 months | 
| reserve rod (mm) | This amount reflects the actual elongation of the device | 3 months | 
| reserve rod (mm) | This amount reflects the actual elongation of the device | 6 months | 
| reserve rod (mm) | This amount reflects the actual elongation of the device | 12 months | 
| reserve rod (mm) | This amount reflects the actual elongation of the device | 18 months | 
| T1-T12 segment and T1-S1 segment | which reflect the real growth of the spine | 3 months | 
| T1-T12 segment and T1-S1 segment | which reflect the real growth of the spine | 6 months | 
| T1-T12 segment and T1-S1 segment | which reflect the real growth of the spine | 12 months | 
| T1-T12 segment and T1-S1 segment | which reflect the real growth of the spine | 18 months | 
| respiratory function | Translated chest and lung growth, as well as the actual improvement of respiratory function | 6 months | 
| respiratory function | Translated chest and lung growth, as well as the actual improvement of respiratory function | 12 months | 
| respiratory function | Translated chest and lung growth, as well as the actual improvement of respiratory function | 18 months | 
| Pelvic obliquity (mm) | translated improving the overall balance of the trunk of the patient for the group of children with neuromuscular scoliosis | 3 months | 
| Pelvic obliquity (mm) | translated improving the overall balance of the trunk of the patient for the group of children with neuromuscular scoliosis | 6 months | 
| Pelvic obliquity (mm) | translated improving the overall balance of the trunk of the patient for the group of children with neuromuscular scoliosis | 12 months | 
| Pelvic obliquity (mm) | translated improving the overall balance of the trunk of the patient for the group of children with neuromuscular scoliosis | 18 months | 
| Safety of NEMOST | Nature-incidence and severity of complications due to NEMOST : infections, elongation failure, problems with healing after surgery, neurological deficit) Nature and incidence of any medical and surgical intervention in relation to device NEMOST | 3 months | 
| Safety of NEMOST | Nature-incidence and severity of complications due to NEMOST : infections, elongation failure, problems with healing after surgery, neurological deficit) Nature and incidence of any medical and surgical intervention in relation to device NEMOST | 6 months | 
| Safety of NEMOST | Nature-incidence and severity of complications due to NEMOST : infections, elongation failure, problems with healing after surgery, neurological deficit) Nature and incidence of any medical and surgical intervention in relation to device NEMOST | 12 months | 
| Safety of NEMOST | Nature-incidence and severity of complications due to NEMOST : infections, elongation failure, problems with healing after surgery, neurological deficit) Nature and incidence of any medical and surgical intervention in relation to device NEMOST | 18 months | 
| Weight (kg) | Reflecting the improvement in the general and trophic status of the patient | Every month for 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NEMOT device, pediatrics, surgery, progressive scoliosis