Clinical Assessment of a Motorized Spinal Distraction Rod in the Severe to Early Scoliosis Child (ASTS)
Primary Purpose
Scoliosis
Status
Active
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
ASTS
Sponsored by
About this trial
This is an interventional treatment trial for Scoliosis
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
Sites / Locations
- CHU de Toulouse
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ASTS device
Arm Description
Implantation of device ASTS (for ACTIVE TREATMENT SCOLIOSIS SYSTEM ) in children between 4 and 10
Outcomes
Primary Outcome Measures
Ability to Implant the device
The surgeon will have to say if the implantation of the device has been done or not
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
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
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
Change of the implant's length
The elongation of the implant will be measured in mm on the digital radiography
Secondary Outcome Measures
Post-surgical pain
Self-assessment of pain using a visual analog scale
Post-surgical pain
Self-assessment of pain using a visual analog scale
Post-surgical pain
Self-assessment of pain using a visual analog scale
Post-surgical pain
Self-assessment of pain using a visual analog scale
Survey to evaluate the quality of life
Assess quality of life in the questionnaire PedsQL
Survey to evaluate the quality of life
Assess quality of life in the questionnaire PedsQL
Survey to evaluate the quality of life
Assess quality of life in the questionnaire PedsQL
to ease for the surgeon to implant the device,
Number of participant with ease for the surgeon to implant the device,
wound closure without tension,
Number of participant with closure of the wound without tension,
good positioning of the radiographic implant.
Number participant with good positioning of the radiographic implant.
Number of medical visits
Measure of the number of medical visit in the year after implant
Determine the number of iterative extensions made during follow-up
Number of iterative extensions of 1 year.
correction of deformation immediately after the operation,
Number of participant with correction of deformation immediately after the operation,
correction of deformation immediately after the operation,
Number of participant with correction of deformation immediately after the operation,
Loss correction at 1 year
Loss correction at 1 year
Loss correction at 1 year
Loss correction at 1 year
Loss correction at 1 year
Loss correction at 1 year
Increase the distance T1-S1 at 1 year
Increase the distance T1-S1 at 1 year (in mm)
Effective Elongation measured on radiographs of specification of the device (in mm)
Effective Elongation measured on radiographs of specification of the device (in mm)
Effective Elongation measured on radiographs of specification of the device
Effective Elongation measured on radiographs of specification of the device (in mm)
Effective Elongation measured on radiographs of specification of the device
Effective Elongation measured on radiographs of specification of the device (in mm)
Effective Elongation measured on radiographs of specification of the device
Effective Elongation measured on radiographs of specification of the device (in mm)
Nature of complications
describe the nature of complication
Nature of complications
describe the nature of complication
Nature of complications
describe the nature of complication
Nature of complications
describe the nature of complication
Full Information
NCT ID
NCT03330158
First Posted
July 11, 2016
Last Updated
March 29, 2023
Sponsor
University Hospital, Toulouse
1. Study Identification
Unique Protocol Identification Number
NCT03330158
Brief Title
Clinical Assessment of a Motorized Spinal Distraction Rod in the Severe to Early Scoliosis Child
Acronym
ASTS
Official Title
Clinical Assessment of a Motorized Spinal Distraction Rod in the Severe to Early Scoliosis Child
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 5, 2019 (Actual)
Primary Completion Date
February 2025 (Anticipated)
Study Completion Date
April 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scoliosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ASTS device
Arm Type
Experimental
Arm Description
Implantation of device ASTS (for ACTIVE TREATMENT SCOLIOSIS SYSTEM ) in children between 4 and 10
Intervention Type
Device
Intervention Name(s)
ASTS
Intervention Description
Implantation of a motorized spinal distraction rod
Primary Outcome Measure Information:
Title
Ability to Implant the device
Description
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
Title
Change of the position of the implant
Description
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
Title
Change of the position of the implant
Description
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
Title
Change of the position of the implant
Description
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
Title
Change of the implant's length
Description
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
Secondary Outcome Measure Information:
Title
Post-surgical pain
Description
Self-assessment of pain using a visual analog scale
Time Frame
3 months, after the implantation
Title
Post-surgical pain
Description
Self-assessment of pain using a visual analog scale
Time Frame
months after the implantation
Title
Post-surgical pain
Description
Self-assessment of pain using a visual analog scale
Time Frame
9 months after the implantation
Title
Post-surgical pain
Description
Self-assessment of pain using a visual analog scale
Time Frame
1 year after the implantation
Title
Survey to evaluate the quality of life
Description
Assess quality of life in the questionnaire PedsQL
Time Frame
Day 0
Title
Survey to evaluate the quality of life
Description
Assess quality of life in the questionnaire PedsQL
Time Frame
6 months after the implantation
Title
Survey to evaluate the quality of life
Description
Assess quality of life in the questionnaire PedsQL
Time Frame
1 year after the implantation
Title
to ease for the surgeon to implant the device,
Description
Number of participant with ease for the surgeon to implant the device,
Time Frame
Day 0
Title
wound closure without tension,
Description
Number of participant with closure of the wound without tension,
Time Frame
Day 0
Title
good positioning of the radiographic implant.
Description
Number participant with good positioning of the radiographic implant.
Time Frame
Day 0
Title
Number of medical visits
Description
Measure of the number of medical visit in the year after implant
Time Frame
1 year
Title
Determine the number of iterative extensions made during follow-up
Description
Number of iterative extensions of 1 year.
Time Frame
1 year
Title
correction of deformation immediately after the operation,
Description
Number of participant with correction of deformation immediately after the operation,
Time Frame
3 months, 6 months, 9 month and 1 year
Title
correction of deformation immediately after the operation,
Description
Number of participant with correction of deformation immediately after the operation,
Time Frame
3 months after implantation
Title
Loss correction at 1 year
Description
Loss correction at 1 year
Time Frame
6 months after implantation
Title
Loss correction at 1 year
Description
Loss correction at 1 year
Time Frame
9 month after implantation
Title
Loss correction at 1 year
Description
Loss correction at 1 year
Time Frame
1 year after implantation
Title
Increase the distance T1-S1 at 1 year
Description
Increase the distance T1-S1 at 1 year (in mm)
Time Frame
1 year
Title
Effective Elongation measured on radiographs of specification of the device (in mm)
Description
Effective Elongation measured on radiographs of specification of the device (in mm)
Time Frame
3 months after implantation
Title
Effective Elongation measured on radiographs of specification of the device
Description
Effective Elongation measured on radiographs of specification of the device (in mm)
Time Frame
6 months after implantation
Title
Effective Elongation measured on radiographs of specification of the device
Description
Effective Elongation measured on radiographs of specification of the device (in mm)
Time Frame
9 month after implantation
Title
Effective Elongation measured on radiographs of specification of the device
Description
Effective Elongation measured on radiographs of specification of the device (in mm)
Time Frame
1 year after implantation
Title
Nature of complications
Description
describe the nature of complication
Time Frame
1 years
Title
Nature of complications
Description
describe the nature of complication
Time Frame
2 years
Title
Nature of complications
Description
describe the nature of complication
Time Frame
3 years
Title
Nature of complications
Description
describe the nature of complication
Time Frame
5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Franck Accadbled, MD PhD
Organizational Affiliation
University Hospital, Toulouse
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Toulouse
City
Toulouse
ZIP/Postal Code
31000
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
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Clinical Assessment of a Motorized Spinal Distraction Rod in the Severe to Early Scoliosis Child
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