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NCT01504438 · ClinicalTrials.gov registry record · NA
Prospective Randomized Evaluation of a Two and Three Piece Total Ankle Replacement
A NA study, sponsored by Duke University.
- Completed
- Registry status
- NA
- Development phase
- 100
- Enrollment target
NCT01504438: Completed NA study, sponsored by Duke University.
NCT01504438 is a NA study that has completed, run by Duke University. The registered enrollment target is 100 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01504438, a NA study, has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- NA
- Development phase
- 100 participants
- Enrollment target
Study Summary
This is a randomized study to prospectively compare and evaluate the functional outcome and patient satisfaction of total ankle replacements for tibio-talar osteoarthritis using either the STAR or Salto-Talaris prothesis.
Primary Outcome
To assess changes in pain across time following total ankle replacement. The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a mark on a 100mm line that represents a continuum between "no pain" and "worst pain." A score of 0 represents less pain intensity while a score of 100 represents high pain intensity
Interventions
- DEVICE Salto-Talaris Total Ankle Replacement
- DEVICE STAR Total Ankle Replacement
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2011-10 |
| Est. Completion | 2020-03-04 |
| Phase | NA |
What the finished NCT01504438 record still lists
NCT01504438 is an interventional study that assigns participants to a tested intervention. The registered 100 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 (93% lower).
The record links to 0 conditions, and to 2 interventions - of which Salto-Talaris Total Ankle Replacement is the first listed.
NCT01504438 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01504438 about?
NCT01504438 is a clinical study titled "Prospective Randomized Evaluation of a Two and Three Piece Total Ankle Replacement". This is a randomized study to prospectively compare and evaluate the functional outcome and patient satisfaction of total ankle replacements for tibio-talar osteoarthritis using either the STAR or Salto-Talaris prothesis.
What is the current status of trial NCT01504438?
This trial is currently completed. It is a NA study. The enrollment target is 100 participants. The study started on 2011-10. Estimated completion is 2020-03-04.
What interventions are being tested in trial NCT01504438?
The interventions under investigation include: Salto-Talaris Total Ankle Replacement (DEVICE), STAR Total Ankle Replacement (DEVICE).
Who is sponsoring clinical trial NCT01504438?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01504438's enrollment target sits among peer trials
100 840th of 2000 higher than 1,081 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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