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

  • STATUS
    Recruiting
  • End date
    Apr 26, 2025
  • participants needed
    5
  • sponsor
    University Hospital, Toulouse
Updated on 26 January 2021

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.

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.

Details
Condition Scoliosis
Treatment ASTS
Clinical Study IdentifierNCT03330158
SponsorUniversity Hospital, Toulouse
Last Modified on26 January 2021

Eligibility

Yes No Not Sure

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
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