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

NCT03330158 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2025-09-08

No results posted yet for this study

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.

Conditions

  • Scoliosis

Interventions

DEVICE

ASTS

Implantation of a motorized spinal distraction rod

Sponsors & Collaborators

  • University Hospital, Toulouse

    lead OTHER

Principal Investigators

  • Franck Accadbled, MD PhD · University Hospital, Toulouse

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
4 Years
Max Age
10 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-05
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03330158 on ClinicalTrials.gov