Treatment Outcomes for Ankle Arthritis

StatusCompleted
PhaseNot specified
Started

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Record History

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  1. Trial status: Active, Not Recruiting to Completedv48
  2. Study completion date: Aug 30, 2024 to Dec 31, 2025v47
  3. Re-verified, no change to tracked fieldsv46
  4. Site details revisedv45
  5. 9 versions Re-verified since Aug 1, 2018, no change to tracked fieldsv36-v44
Show 34 earlier versionsHide 34 earlier versions
  1. Enrollment target: 369 to 368v35
  2. Enrollment target: 368 to 369v34
  3. Study completion date: Aug 2018 to Aug 30, 2024
    • Study description expanded, about 24 words
    v33
  4. Primary completion date: Aug 2015 to Aug 1, 2015
    • Start date: Mar 2005 to Mar 1, 2005
    v32
  5. Results first posted: Dec 21, 2016v31 Show 6 more changesShow less
    • Primary endpoints: 2 to 1
    • Enrollment target: 358 to 368
    • Study completion date: Jul 2018 to Aug 2018
    • Start date: Oct 2006 to Mar 2005
    • Secondary endpoints: 1 to 2
    • Study description expanded, about 4 words
  6. Re-verified, no change to tracked fieldsv30
  7. Primary completion date: Jun 2016 to Aug 2015v29
  8. Re-verified, no change to tracked fieldsv28
  9. Primary completion date: Aug 2015 to Jun 2016v27
  10. Primary completion date changed from estimate of Aug 2018 to Aug 2015
    • Study completion date: Jul 2030 to Jul 2018
    • Study description shortened, about 42 words
    v26
  11. Primary completion date: Jun 2015 to Aug 2018
    • Study completion date: Jul 2022 to Jul 2030
    • Study description expanded, about 42 words
    v25
  12. Lead sponsor: US Department of Veterans Affairs to VA Office of Research and Development
    • Study completion date: Sep 2015 to Jul 2022
    • Study description expanded, about 3 words
    v24
  13. Study site revisedv23
  14. Enrollment target: estimated 500 to confirmed 358
    • Eligibility criteria shortened, about 1 word
    v22
  15. Primary endpoints: 1 to 2
    • Eligibility criteria revised
    • Study description expanded, about 53 words
    v21
  16. Collaborators revised (3)v20
  17. Collaborators revised (3)v19
  18. 2 versions Re-verified since Mar 6, 2013, no change to tracked fieldsv17-v18
  19. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    • Eligibility criteria shortened, about 1 word
    v16
  20. Primary completion date: Dec 2014 to Jun 2015
    • Eligibility criteria expanded, about 17 words
    • Site contact updated
    v15
  21. Re-verified, no change to tracked fieldsv14
  22. Primary completion date: Sep 2012 to Dec 2014v13 Show 4 more changesShow less
    • Eligibility criteria expanded, about 13 words
    • Study description shortened, about 7 words
    • Collaborators revised (3)
    • Secondary endpoints expanded, about 2 words
  23. Re-verified, no change to tracked fieldsv12
  24. Enrollment target: 225 to 500v11 Show 4 more changesShow less
    • Primary completion date: Oct 2012 to Sep 2012
    • Study completion date: Oct 2012 to Sep 2015
    • Study description revised
    • Site contact updated
  25. Study description revised
    • Collaborators: 2 to 3
    v10
  26. Study description expanded, about 1 wordv9
  27. Re-verified, no change to tracked fieldsv8
  28. Site contact updated
    • Collaborators expanded, about 14 words
    v7
  29. Site contact updatedv6
  30. Enrollment target: 120 to 225
    • Study description shortened, about 114 words
    v5
  31. 2 versions Re-verified since Sep 5, 2008, no change to tracked fieldsv3-v4
  32. Trial status: Not Yet Recruiting to Recruitingv2 Show 6 more changesShow less
    • Enrollment target: 60 to 120
    • Primary completion date: Oct 2012
    • Eligibility criteria shortened, about 27 words
    • Study description shortened, about 6 words
    • Study site revised
    • Study arms: 0 to 2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT00391365
Lead Sponsor VA Office of Research and Development
Collaborators: Orthopaedic Associates of Michigan (Grand Rapids, MI), Orthopedic + Fracture Specialists, Portland, OR, Minnesota Orthopedic Sports Medicine Institute Twin Cities Orthopedics (Edina, MN)
Conditions
(from sponsor)		 Osteoarthritis
Related terms Ankylosis, Arthritis, Osteoarthritis
Enrollment 368 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov