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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
5
Implantation of a motorized spinal distraction rod
CHU de Toulouse
Toulouse, France
Ability to Implant the device
The surgeon will have to say if the implantation of the device has been done or not
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 3 months, 6 months, 9 months, 1 year, 2 years and 3 years after the implantation
Post-surgical pain
Self-assessment of pain using a visual analog scale
Time frame: 3 months, after the implantation
Post-surgical pain
Self-assessment of pain using a visual analog scale
Time frame: months after the implantation
Post-surgical pain
Self-assessment of pain using a visual analog scale
Time frame: 9 months after the implantation
Post-surgical pain
Self-assessment of pain using a visual analog scale
Time frame: 1 year after the implantation
Survey to evaluate the quality of life
Assess quality of life in the questionnaire PedsQL
Time frame: Day 0
Survey to evaluate the quality of life
Assess quality of life in the questionnaire PedsQL
Time frame: 6 months after the implantation
Survey to evaluate the quality of life
Assess quality of life in the questionnaire PedsQL
Time frame: 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,
Time frame: Day 0
wound closure without tension,
Number of participant with closure of the wound without tension,
Time frame: Day 0
good positioning of the radiographic implant.
Number participant with good positioning of the radiographic implant.
Time frame: Day 0
Number of medical visits
Measure of the number of medical visit in the year after implant
Time frame: 1 year
Determine the number of iterative extensions made during follow-up
Number of iterative extensions of 1 year.
Time frame: 1 year
correction of deformation immediately after the operation,
Number of participant with correction of deformation immediately after the operation,
Time frame: 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,
Time frame: 3 months after implantation
Loss correction at 1 year
Loss correction at 1 year
Time frame: 6 months after implantation
Loss correction at 1 year
Loss correction at 1 year
Time frame: 9 month after implantation
Loss correction at 1 year
Loss correction at 1 year
Time frame: 1 year after implantation
Increase the distance T1-S1 at 1 year
Increase the distance T1-S1 at 1 year (in mm)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 1 year after implantation
Nature of complications
describe the nature of complication
Time frame: 1 years
Nature of complications
describe the nature of complication
Time frame: 2 years
Nature of complications
describe the nature of complication
Time frame: 3 years
Nature of complications
describe the nature of complication
Time frame: 5 years
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