New motorized rod could straighten spines without repeated surgeries
NCT ID NCT03330158
First seen Jun 26, 2026 · Last updated Sep 01, 2026 · Updated 2 times
Summary
This study tests a new motorized spinal rod (ASTS) in 5 children aged 4-10 with severe early-onset scoliosis. The rod is implanted and can be lengthened remotely to correct the spine curve over time. The goal is to see if the device is safe and works as intended, potentially reducing pain and complications compared to traditional treatments.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- motorized spinal distraction rod (ASTS device)
- What this could lead to
- If successful, this device could offer a less invasive way to correct severe scoliosis in young children, potentially reducing pain and the need for repeated surgeries.
- What could go wrong
- This is a very small, early feasibility study with only 5 participants, so results may not apply to all children. The device may fail to correct the curve or cause complications like infection or implant failure.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
-
5 people
The number who actually took part.
- Started
-
Feb 2019
- Finished
-
Dec 2025
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
4 to 10 years
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
CHU de Toulouse
Toulouse, 31000, France
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Other studies related to the condition(s) this trial covers.
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