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NCT01551264 · ClinicalTrials.gov registry record · NA
Duration of Brace Wear in Clubfoot Treatment - A Prospective Randomized Trial
A NA study, sponsored by Washington University School of Medicine.
- Completed
- Registry status
- NA
- Development phase
- 139
- Enrollment target
NCT01551264: Completed NA study, sponsored by Washington University School of Medicine.
NCT01551264 is a NA study that has completed, run by Washington University School of Medicine. The registered enrollment target is 139 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01551264, a NA study, has completed, sponsored by Washington University School of Medicine.
- COMPLETED
- Registry status
- NA
- Development phase
- 139 participants
- Enrollment target
Study Summary
The goal of this multi-center, randomized, controlled trial is to evaluate the effectiveness of a 2 year versus 4 year bracing protocol in preventing isolated clubfoot recurrence within the first year post-treatment, and to evaluate factors associated with recurrence in isolated clubfoot.
Primary Outcome
Kaplan-Meier recurrence-free survival probability for each limb affected by clubfoot up to 1 year after bracing is discontinued. For patients with bilateral clubfoot, each limb was assessed. Bilateral patients contribute data for both limbs and unilateral patients contribute data for the affected limb. Recurrence is defined as the development of any of the following deformities in isolation or in combination that require repeat cast application or surgical intervention: hindfoot varus, ankle equ
Interventions
- DEVICE Foot Abduction Brace (FAB)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 139 participants |
| Start Date | 2012-05 |
| Est. Completion | 2019-10-15 |
| Phase | NA |
What the finished NCT01551264 record still lists
NCT01551264 is an interventional study that assigns participants to a tested intervention. The registered 139 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 1 intervention - of which Foot Abduction Brace (FAB) is the first listed.
NCT01551264 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01551264 about?
NCT01551264 is a clinical study titled "Duration of Brace Wear in Clubfoot Treatment - A Prospective Randomized Trial". The goal of this multi-center, randomized, controlled trial is to evaluate the effectiveness of a 2 year versus 4 year bracing protocol in preventing isolated clubfoot recurrence within the first year post-treatment, and to evaluate factors associated with recurrence in isolated clubfoot.
What is the current status of trial NCT01551264?
This trial is currently completed. It is a NA study. The enrollment target is 139 participants. The study started on 2012-05. Estimated completion is 2019-10-15.
What interventions are being tested in trial NCT01551264?
The interventions under investigation include: Foot Abduction Brace (FAB) (DEVICE).
Who is sponsoring clinical trial NCT01551264?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01551264's enrollment target sits among peer trials
139 720th of 2000 higher than 1,281 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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