Spine surgery study in toddlers pulled before it began
NCT ID NCT04527406
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study aimed to see if operating on a congenital spine deformity (hemivertebra) in children aged 3-5 is better than waiting until after age 5. Children would have been randomly assigned to early surgery or bracing followed by later surgery. However, the study was withdrawn before enrolling any participants, so no conclusions can be drawn.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- posterior hemivertebra resection (surgery)
- What this could lead to
- If successful, this could show that operating earlier (ages 3-5) improves spine alignment and reduces the need for later, more complex surgery.
- What could go wrong
- The study was withdrawn before any children were enrolled, so no results are available. Surgery in very young children carries risks like infection, bleeding, or need for repeat operations.
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.
- Expected to start
-
Mar 2025
An estimate. Start dates often move.
- Expected to finish
-
Dec 2028
An estimate. End dates often move.
- Lead sponsor
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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
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3 to 5 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.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Single-segment thoracic or lumbar hemivertebrae scoliosis diagnosed by X-ray and CT. Exclusion Criteria: * Diagnosed with syndrome of scoliosis, osteochondrodysplasia, multi-segment hemivertebrae deformity, cervical hemivertebrae deformity
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.