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

Toulouse University Hospital

Status

Active, not recruiting

Conditions

Scoliosis

Treatments

Device: ASTS

Study type

Interventional

Funder types

Other

Identifiers

NCT03330158

RC31/15/7851

Details and patient eligibility

About

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.

Full 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.

Enrollment

5 patients

Sex

All

Ages

4 to 10 years old

Volunteers

No Healthy Volunteers

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