Clinical Assessment of a Motorized Spinal Distraction Rod in the Severe to Early Scoliosis Child

Study Overview
=================
Brief Summary
-----------------
The purpose of this biomedical research is to evaluate the feasibility of the treatment with the new spinal distraction device ASTS in patients aged 4 to 10 years with severe early onset scoliosis. The hypothesis of this project is that the new fully implantable motorized spinal distraction device may provide a correction of scoliosis and progressive elongation ensuring patient comfort and minimizing complications. The ASTS (for Active Scoliosis Treatment System) growing rod is a new fully implantable motorized spinal distraction device which can ensure a correction of scoliosis and progressive elongation ensuring patient comfort and minimizing complications.

Detailed Description
-----------------
Despite a better understanding and technical progress, the evolutionary early scoliosis remains a therapeutic challenge. The definition includes idiopathic scoliosis beginning before the age of 3 years, congenital scoliosis, neuromuscular and syndromic. Spinal deformity is often progressive and may compromise cardiorespiratory function. The goal of treatment is to prevent further avoiding spinal fusion in a subject in growth. Surgery is indicated in case of failure or cons-indication of conservative treatment (corset or plaster). The principle is to position the posterior rods subcutaneous or in muscle attached to two ends of the deformation. Intraoperative distraction allows correction of the deformity. A new distraction is performed every 6 months until skeletal maturity. Considerable complication rates are reported (58%), mainly implant infections and disassembly, because of the need for multiple reoperations. Motorized implants can potentially avoid repeated interventions limiting complications. Thus, the central hypothesis of this project is a new fully implantable motorized spinal distraction device may provide a correction of scoliosis and progressive elongation ensuring patient comfort and minimizing complications.

Official Title
-----------------
Clinical Assessment of a Motorized Spinal Distraction Rod in the Severe to Early Scoliosis Child

Conditions
-----------------
Scoliosis

Intervention / Treatment
-----------------
* Device: ASTS


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient 4 to 10 years Patient weight between 15kg at 50kg Introducing severe scoliosis (Cobb angle> 40 °) with early onset Failed or cons-indication of conservative treatment (cast or brace) Agreement of parents or legal guardian (written agreement) and the patient (at least an oral agreement). Exclusion Criteria: Contraindication to surgery Age less than 4 years or above 10 years Weight less 15kg and above 50 kg

Ages Eligible for Study
-----------------
Minimum Age: 4 Years
Maximum Age: 10 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ASTS device<br>Implantation of device ASTS (for ACTIVE TREATMENT SCOLIOSIS SYSTEM ) in children between 4 and 10 | Device: ASTS<br>* Implantation of a motorized spinal distraction rod<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ability to Implant the device | The surgeon will have to say if the implantation of the device has been done or not | Day 0: the day of the implantation | 
| Change of the position of the implant | 1 year after the implantation of the device, radiographs will be realised to ensure that the implant is still well positioning | 1 years after the implantation | 
| Change of the position of the implant | 2 years after the implantation of the device, radiographs will be realised to ensure that the implant is still weel positioning | 2 years after the implantation | 
| Change of the position of the implant | 3 years after the implantation of the device, radiographs will be realised to ensure that the implant is still weel positioning | 3 years after the implantation | 
| Change of the implant's length | The elongation of the implant will be measured in mm on the digital radiography | 3 months, 6 months, 9 months, 1 year, 2 years and 3 years after the implantation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-surgical pain | Self-assessment of pain using a visual analog scale | 3 months, after the implantation | 
| Post-surgical pain | Self-assessment of pain using a visual analog scale | months after the implantation | 
| Post-surgical pain | Self-assessment of pain using a visual analog scale | 9 months after the implantation | 
| Post-surgical pain | Self-assessment of pain using a visual analog scale | 1 year after the implantation | 
| Survey to evaluate the quality of life | Assess quality of life in the questionnaire PedsQL | Day 0 | 
| Survey to evaluate the quality of life | Assess quality of life in the questionnaire PedsQL | 6 months after the implantation | 
| Survey to evaluate the quality of life | Assess quality of life in the questionnaire PedsQL | 1 year after the implantation | 
| to ease for the surgeon to implant the device, | Number of participant with ease for the surgeon to implant the device, | Day 0 | 
| wound closure without tension, | Number of participant with closure of the wound without tension, | Day 0 | 
| good positioning of the radiographic implant. | Number participant with good positioning of the radiographic implant. | Day 0 | 
| Number of medical visits | Measure of the number of medical visit in the year after implant | 1 year | 
| Determine the number of iterative extensions made during follow-up | Number of iterative extensions of 1 year. | 1 year | 
| correction of deformation immediately after the operation, | Number of participant with correction of deformation immediately after the operation, | 3 months, 6 months, 9 month and 1 year | 
| correction of deformation immediately after the operation, | Number of participant with correction of deformation immediately after the operation, | 3 months after implantation | 
| Loss correction at 1 year | Loss correction at 1 year | 6 months after implantation | 
| Loss correction at 1 year | Loss correction at 1 year | 9 month after implantation | 
| Loss correction at 1 year | Loss correction at 1 year | 1 year after implantation | 
| Increase the distance T1-S1 at 1 year | Increase the distance T1-S1 at 1 year (in mm) | 1 year | 
| Effective Elongation measured on radiographs of specification of the device (in mm) | Effective Elongation measured on radiographs of specification of the device (in mm) | 3 months after implantation | 
| Effective Elongation measured on radiographs of specification of the device | Effective Elongation measured on radiographs of specification of the device (in mm) | 6 months after implantation | 
| Effective Elongation measured on radiographs of specification of the device | Effective Elongation measured on radiographs of specification of the device (in mm) | 9 month after implantation | 
| Effective Elongation measured on radiographs of specification of the device | Effective Elongation measured on radiographs of specification of the device (in mm) | 1 year after implantation | 
| Nature of complications | describe the nature of complication | 1 years | 
| Nature of complications | describe the nature of complication | 2 years | 
| Nature of complications | describe the nature of complication | 3 years | 
| Nature of complications | describe the nature of complication | 5 years |