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NCT00391365 · ClinicalTrials.gov registry record
Treatment Outcomes for Ankle Arthritis
A clinical trial, sponsored by VA Office of Research and Development.
- Completed
- Registry status
- 368
- Enrollment target
NCT00391365: Completed study, sponsored by VA Office of Research and Development.
NCT00391365 is a clinical trial that has completed, run by VA Office of Research and Development. The registered enrollment target is 368 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00391365 has completed, sponsored by VA Office of Research and Development.
- COMPLETED
- Registry status
- 368 participants
- Enrollment target
Study Summary
The purpose of this study is to determine any functional outcome differences in patients who have undergone surgical treatment for ankle osteoarthritis using surveys, step counts, and laboratory gait analysis. This study is closed to recruitment; follow-up procedures are completed; the study remains open for data analysis. Enrollment was completed by August 2012. As of July 2016, the study is currently analyzing data. In April 2017 the study was approved to begin long term follow-up with study participants. Study personnel contact participants via telephone and/or U.S. Mail to tell them about long term follow-up, and to ask whether they are willing to continue study participation. Long term follow-up will be for up to 12 years after the participant's ankle surgery.
Primary Outcome
Patient reported data using the MFA, a general functional assessment intended as a tool for evaluation of patients' perceptions of their physical, psychological, and social well-being that asks patients to assess their function on 100 items. Number shows change in outcome from pre-op to 3 years by surgery type, with a lower score implying an improved outcome (scale range 0 -100.)
Interventions
- PROCEDURE Gait analysis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 368 participants |
| Start Date | 2005-03-01 |
| Est. Completion | 2025-12-31 |
What the finished NCT00391365 record still lists
NCT00391365 is an observational study that tracks outcomes without assigning an intervention. The registered 368 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 1 intervention - of which Gait analysis is the first listed.
NCT00391365 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00391365 about?
NCT00391365 is a clinical study titled "Treatment Outcomes for Ankle Arthritis". The purpose of this study is to determine any functional outcome differences in patients who have undergone surgical treatment for ankle osteoarthritis using surveys, step counts, and laboratory gait analysis. This study is closed to recruitment; follow-up procedures are completed; the study remain...
What is the current status of trial NCT00391365?
This trial is currently completed. The enrollment target is 368 participants. The study started on 2005-03-01. Estimated completion is 2025-12-31.
What interventions are being tested in trial NCT00391365?
The interventions under investigation include: Gait analysis (PROCEDURE).
Who is sponsoring clinical trial NCT00391365?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
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