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NCT00412035 · ClinicalTrials.gov registry record · Phase 3

Botox Injection for Lower Extremity Lengthening and Deformity Correction Surgery

A Phase 3 study, sponsored by Shriners Hospitals for Children.

Completed
Registry status
Phase 3
Development phase
125
Enrollment target

NCT00412035: Completed Phase 3 study, sponsored by Shriners Hospitals for Children.

NCT00412035 is a Phase 3 study that has completed, run by Shriners Hospitals for Children. The registered enrollment target is 125 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (84% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00412035, a Phase 3 study, has completed, sponsored by Shriners Hospitals for Children.

COMPLETED
Registry status
Phase 3
Development phase
125 participants
Enrollment target

Study Summary

The purpose of this six site multi-center study is to determine if BTX-A can alleviate the post-operative pain and improve the functional and quality of life outcomes of children with limb length discrepancy or angular deformity undergoing limb lengthening or deformity correction.

Interventions

  • DRUG Botulinum toxin A injection
  • DRUG saline injection

Trial Details

FieldValue
Enrollment Target 125 participants
Start Date 2007-01
Est. Completion 2012-12
Phase Phase 3
Shriners Hospitals for Children

40 total trials

What the finished NCT00412035 record still lists

NCT00412035 is an interventional study that assigns participants to a tested intervention. The registered 125 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (84% lower).

The record links to 0 conditions, and to 2 interventions - of which Botulinum toxin A injection is the first listed.

NCT00412035 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00412035 about?

NCT00412035 is a clinical study titled "Botox Injection for Lower Extremity Lengthening and Deformity Correction Surgery". The purpose of this six site multi-center study is to determine if BTX-A can alleviate the post-operative pain and improve the functional and quality of life outcomes of children with limb length discrepancy or angular deformity undergoing limb lengthening or deformity correction.

What is the current status of trial NCT00412035?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 125 participants. The study started on 2007-01. Estimated completion is 2012-12.

What interventions are being tested in trial NCT00412035?

The interventions under investigation include: Botulinum toxin A injection (DRUG), saline injection (DRUG).

Who is sponsoring clinical trial NCT00412035?

This trial is sponsored by Shriners Hospitals for Children, which has 40 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00412035's enrollment target sits among peer trials

125 1605th of 2000 higher than 391 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00412035, the US trial registry maintained by the National Library of Medicine. NCT00412035 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.