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NCT03853811 · ClinicalTrials.gov registry record · NA
Customized Orthosis for Children With Clubfoot
A NA study, sponsored by Medical College of Wisconsin.
- Terminated
- Registry status
- NA
- Development phase
- 3
- Enrollment target
NCT03853811: Clinical Trial NA study, sponsored by Medical College of Wisconsin.
NCT03853811 is a NA study that was terminated before completion, run by Medical College of Wisconsin. The registered enrollment target is 3 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03853811, a NA study, was terminated before completion, sponsored by Medical College of Wisconsin.
- TERMINATED
- Registry status
- NA
- Development phase
- 3 participants
- Enrollment target
Study Summary
This study will examine the use of a novel customized Ankle Foot Orthosis (AFO), created using 3D scanning, with children being treated for clubfoot. The AFO is inserted in the standard Mitchell shoe during bracing, following Ponseti casting. The investigators hypothesize that following Ponseti casting, the implementation of customized AFOs with Ponseti bracing will improve patient compliance and functional outcomes as well as lead to fewer relapses in comparison to the standard bracing with Mitchell shoes.
Primary Outcome
Assessed using changes in Dimeglio Scores. The Dimeglio scoring system uses a 20-point system (20 being the most severe and \<5 as benign) by assessing four parameters. The severity of the deformity is then assigned a grade of I-IV with IV being the most severe. (A score of \<5 is given a grade of I, =5\<10 is grade II, =10\<15 is grade III, and =15\<20 is grade IV)
Interventions
- DEVICE Ankle Foot Orthosis (AFO)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2019-04-17 |
| Est. Completion | 2022-03-02 |
| Phase | NA |
Why NCT03853811 stopped before completion
NCT03853811 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower).
The record links to 0 conditions, and to 1 intervention - of which Ankle Foot Orthosis (AFO) is the first listed.
NCT03853811 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03853811 about?
NCT03853811 is a clinical study titled "Customized Orthosis for Children With Clubfoot". This study will examine the use of a novel customized Ankle Foot Orthosis (AFO), created using 3D scanning, with children being treated for clubfoot. The AFO is inserted in the standard Mitchell shoe during bracing, following Ponseti casting. The investigators hypothesize that following Ponseti cast...
What is the current status of trial NCT03853811?
This trial is currently terminated. It is a NA study. The enrollment target is 3 participants. The study started on 2019-04-17. Estimated completion is 2022-03-02.
What interventions are being tested in trial NCT03853811?
The interventions under investigation include: Ankle Foot Orthosis (AFO) (DEVICE).
Who is sponsoring clinical trial NCT03853811?
This trial is sponsored by Medical College of Wisconsin, which has 447 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03853811's enrollment target sits among peer trials
3 1996th of 2000 higher than 4 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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