Clinical Assessment of a Motorized Spinal Distraction Rod in the Severe to Early Scoliosis Child
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Scoliosis
- Sponsor
- University Hospital, Toulouse
- Enrollment
- 5
- Locations
- 1
- Primary Endpoint
- Change of the position of the implant
- Status
- Active, Not Recruiting
- Last Updated
- 7 months ago
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.
Investigators
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
Outcomes
Primary Outcomes
Change of the position of the implant
Time Frame: 3 years after the implantation
3 years after the implantation of the device, radiographs will be realised to ensure that the implant is still weel positioning
Ability to Implant the device
Time Frame: Day 0: the day of the implantation
The surgeon will have to say if the implantation of the device has been done or not
Change of the implant's length
Time Frame: 3 months, 6 months, 9 months, 1 year, 2 years and 3 years after the implantation
The elongation of the implant will be measured in mm on the digital radiography
Secondary Outcomes
- Determine the number of iterative extensions made during follow-up(1 year)
- correction of deformation immediately after the operation,(3 months after implantation)
- Nature of complications(5 years)
- Post-surgical pain(1 year after the implantation)
- wound closure without tension,(Day 0)
- Number of medical visits(1 year)
- Effective Elongation measured on radiographs of specification of the device(1 year after implantation)
- good positioning of the radiographic implant.(Day 0)
- Loss correction at 1 year(1 year after implantation)
- Effective Elongation measured on radiographs of specification of the device (in mm)(3 months after implantation)
- Survey to evaluate the quality of life(1 year after the implantation)
- to ease for the surgeon to implant the device,(Day 0)
- Increase the distance T1-S1 at 1 year(1 year)