Status:
ACTIVE_NOT_RECRUITING
Clinical Assessment of a Motorized Spinal Distraction Rod in the Severe to Early Scoliosis Child
Lead Sponsor:
University Hospital, Toulouse
Conditions:
Scoliosis
Eligibility:
All Genders
4-10 years
Phase:
NA
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. T...
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 year...
Eligibility Criteria
Inclusion
- 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
- Contraindication to surgery
- Age less than 4 years or above 10 years
- Weight less 15kg and above 50 kg
Key Trial Info
Start Date :
February 5 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2025
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT03330158
Start Date
February 5 2019
End Date
December 1 2025
Last Update
September 8 2025
Active Locations (1)
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1
CHU de Toulouse
Toulouse, France, 31000