Treatment Outcomes for Ankle Arthritis (NCT00391365) | Clinical Trial Compass
CompletedNot Applicable
Treatment Outcomes for Ankle Arthritis
United States368 participantsStarted 2005-03-01
Plain-language 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.
Who can participate
Age range
18 Years – 89 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Ankle arthritis subjects will be recruited from patients at
* VA Puget Sound Health Care System (Seattle, WA)
* Harborview Medical Center (Seattle, WA)
* Orthopaedic Associates of Michigan (Grand Rapids, MI)
* Orthopedic + Fracture Specialists (Portland, OR)
* Twin Cities Orthopedics (Edina, MN)
* who have been diagnosed with end stage ankle arthrosis
* are ambulatory
* speak English
* are cognitively intact
* between the ages of 18-89
* and have elected to undergo surgical correction (arthrodesis or arthroplasty) for end-stage ankle arthritis
Exclusion Criteria:
* Suffer from Rheumatoid Arthritis or other systemic arthritis
* Have any other diseased lower extremity joints or traumatic lower extremity injury that grossly inhibits normal gait
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.