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Treatment Outcomes for Ankle Arthritis

StatusCompleted
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Amendment history

  1. Minor

    Trial status: Active, Not Recruiting to Completed

    Study Statusv48

  2. Minor

    Completion date: Aug 30, 2024 to Dec 31, 2025

    Study Statusv47

  3. Minor

    Study Status

    Re-verified, no change to tracked fields

    v46

  4. Minor

    Site details revised

    Study Status, Contacts/Locationsv45

  5. Minor

    9 amendments

    9 re-verifications since 2018-08-01, no change to tracked fields

    v36-v44

Show 34 earlier versions

  1. Minor

    Enrollment target: 369 to 368

    Study Status, Study Designv35

  2. Minor

    Enrollment target: 368 to 369

    Study Status, Study Designv34

  3. Minor

    Completion date: Aug 2018 to Aug 30, 2024

    Study description expanded, about 24 words

    Show what changed: Study description
    [...] ill occur prior to surgical intervention and at 3, 6, 12, 24, and 36 months following the intervention. Long term follow-up using the MFA and SF-36 was approved in April 2017 and will continue until 12 years after the participant's ankle surgery. Assessments using the SAM will occur prior to surgical inter [...]

    Study Status, Oversight, Study Description, Contacts/Locationsv33

  4. Minor

    Primary completion date: Aug 2015 to Aug 1, 2015

    Start date: Mar 2005 to Mar 1, 2005

    Study Status, Baseline Characteristicsv32

  5. Notable

    Results first posted: Dec 21, 2016

    Primary endpoints: 2 to 1; Enrollment target: 358 to 368; Completion date: Jul 2018 to Aug 2018; and 3 more

    Show all 7 changes in this update
    • Notable Results first posted: Dec 21, 2016
    • Notable Primary endpoints: 2 to 1
      Show what changed
      Daily activity level measured by the Step Activity Monitor Pain, Musculoskeletal Functional Assessment (MFA), SF-36 General Health Survey
    • Minor Enrollment target: 358 to 368
    • Minor Completion date: Jul 2018 to Aug 2018
    • Minor Start date: Oct 2006 to Mar 2005
    • Minor Secondary endpoints: 1 to 2
      Show what changed
      GaitPhysical analysisFunction Section of Short Form-36 (SF-36) Bodily Pain Section of Short Form-36 (SF-36)
    • Minor Study description expanded, about 4 words
      Show what changed
      [...] lan: The investigators propose a mobility outcome study with up to 500 ankle osteoarthritis subjects who will undergo correcti [...] vestigators propose a mobility outcome study with a total of up to 500 ankle osteoarthritis subjects before and after surgery [...]

    Study Status, Study Description, Study Design, Outcome Measures, Participant Flow, Baseline Characteristics, Outcome Measures (Results), Adverse Events, Limitations and Caveats, More Informationv31

  6. Minor

    Study Status, Study Description

    Re-verified, no change to tracked fields

    v30

  7. Minor

    Primary completion date: Jun 2016 to Aug 2015

    Study Statusv29

  8. Minor

    Study Status

    Re-verified, no change to tracked fields

    v28

  9. Notable

    Primary completion date: Aug 2015 to Jun 2016

    Study Statusv27

  10. Minor

    Primary completion date changed from estimate of Aug 2018 to Aug 2015

    Completion date: Jul 2030 to Jul 2018; Study description shortened, about 42 words

    Show what changed: Study description
    [...] w Medical Center for the gait analysis portion of the study. As of February 2016 approval has been secured to extend data collection for this cohort for up to eight additional annual assessments (questionnaires) past the 24 month data point. The Step Activity Monitor will not be used after the 24 month assessment.

    Study Status, Study Description, Study Design, IPDSharingv26

  11. Notable

    Primary completion date: Jun 2015 to Aug 2018

    Completion date: Jul 2022 to Jul 2030; Study description expanded, about 42 words

    Show what changed: Study description
    [...] w Medical Center for the gait analysis portion of the study. As of February 2016 approval has been secured to extend data collection for this cohort for up to eight additional annual assessments (questionnaires) past the 24 month data point. The Step Activity Monitor will not be used after the 24 month assessment.

    Study Status, Study Descriptionv25

  12. Notable

    Lead sponsor: US Department of Veterans Affairs to VA Office of Research and Development

    Completion date: Sep 2015 to Jul 2022; Study description expanded, about 3 words

    Show what changed: Study description
    [...] come difference between surgical procedures. Research Plan: WeThe investigators propose a mobility outcome study with 500 ankle osteoarthri [...] subjects who will undergo corrective surgery. Methodology: WeThe investigators propose a mobility outcome study with a total of 500 ankle [...] ce at the VA Puget Sound Health Care System in Seattle, WA. WeThe investigators will only recruit subjects from the VA and Harborview Medical Center for the gait analysis portion of the study.

    Study Status, Sponsor/Collaborators, Study Description, Arms and Interventionsv24

  13. Minor

    Study site revised

    Show what changed: Study sites
    VA Puget Sound Health Care System Seattle Division, Seattle, WA

    Study Status, Contacts/Locationsv23

  14. Minor

    Enrollment target: estimated 500 to confirmed 358

    Eligibility criteria shortened, about 1 word

    Show what changed: Eligibility criteria
    Inclusion Criteria: Ankle arthritis subjects will be recruited from patients at the VA Puget Sound Health Care System (Seattle, WA) Harborview M [...]

    Study Status, Study Description, Study Design, Eligibilityv22

  15. Notable

    Primary endpoints: 1 to 2

    Eligibility criteria revised; Study description expanded, about 53 words

    Show what changed: Primary endpoints
    Pain, Musculoskeletal Functional Assessment (MFA), SF-36 General Health Survey
    Show what changed: Eligibility criteria
    [...] speak English are cognitively intact between the ages of 18-8089 and have elected to undergo surgical correction (arthrodesi [...]
    Show what changed: Study description
    [...] uited from patients at the VA Puget Sound Health Care System (Seattle, WA), Harborview Medical Center and(Seattle, UniversityWA), Orthopedic + Fracture Specialists (Portland, OR), Orthopaedic Associates of WashingtonMichigan Medical(Grand CenterRapids, MN), and Twin Cities Orthopedics (Edina, MN) who have been diagnosed with end stage ankle arthrosis, are [...] dures and the experimental protocol will be approved by the University of Washington Human SubjectsInstitutional Review CommitteeBoard (IRB) at each study site. Since there is no clinical equipoise it would be unethical [...] surgical intervention a [...]

    Study Status, Study Description, Outcome Measures, Eligibility, Contacts/Locationsv21

  16. Minor

    Collaborators revised (3)

    Show what changed: Collaborators
    Orthopaedic Associates of Michigan, PC (Grand Rapids, MI)

    Study Status, Sponsor/Collaboratorsv20

  17. Minor

    Collaborators revised (3)

    Show what changed: Collaborators
    Orthopaedic Associates of Michigan, PC (Grand Rapids, MI)

    Study Status, Sponsor/Collaborators, Study Descriptionv19

  18. Minor

    2 amendments

    2 re-verifications since 2013-03-06, no change to tracked fields

    v17-v18

  19. Minor

    Trial status: Recruiting to Active, Not Recruiting

    Eligibility criteria shortened, about 1 word; Site details revised

    Show what changed: Eligibility criteria
    [...] ients at the 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), and 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 18-80, and have elected to undergo surgical correction (arthrodesis or arthroplasty) for end-stage ankle arthritis. Exclusion Criteria: Suffer from Rheumatoid Arthritis or oth [...]

    Study Status, Study Description, Eligibility, Contacts/Locationsv16

  20. Minor

    Primary completion date: Dec 2014 to Jun 2015

    Eligibility criteria expanded, about 17 words; Site contact updated

    Show what changed: Eligibility criteria
    Inclusion Criteria: Ankle arthritis subjects will be recruited from patients at the VA Puget Sound Health Care System (Seattle, WA), Harborview Medical Center and(Seattle, UniversityWA), Orthopaedic Associates of WashingtonMichigan Medical(Grand CenterRapids, MI), Orthopedic + Fracture Specialists (Portland, OR), and Twin Cities Orthopedics (Edina, MN) who have been diagnosed with end stage ankle arthrosis, are [...]

    Study Identification, Study Status, Arms and Interventions, Eligibility, Contacts/Locationsv15

  21. Minor

    Study Status

    Re-verified, no change to tracked fields

    v14

  22. Notable

    Primary completion date: Sep 2012 to Dec 2014

    Eligibility criteria expanded, about 13 words; Secondary endpoints expanded, about 2 words; Study description shortened, about 7 words; and 1 more

    Show all 5 changes in this update
    • Notable Primary completion date: Sep 2012 to Dec 2014
    • Minor Eligibility criteria expanded, about 13 words
      Show what changed
      [...] sis, are ambulatory, speak English, are cognitively intact, and between the ages of 18-80, and have elected to undergo surgical correction (arthrodesis or arthroplasty) for end-stage ankle arthritis. Exclusion Criteria: Suffer from Rheumatoid Arthritis or ot [...]
    • Minor Secondary endpoints expanded, about 2 words
      Show what changed
      Gait analysis
    • Minor Study description shortened, about 7 words
      Show what changed
      [...] before and after surgery over the three years of the study. Fifteen normal adults will also be tested. Ankle arthritis subjects will be recruited from patients at [...] ankle joint replacement). The outcomes will be assessed in threetwo domains: Functional domain: Each subject's functional statu [...]
    • Minor Collaborators revised (3)
      Show what changed
      OrthopedicOrthopaedic Associates of Grand Rapids (Grand RapidsMichigan, MI)PC

    Study Status, Sponsor/Collaborators, Oversight, Study Description, Outcome Measures, Eligibilityv13

  23. Minor

    Study Status

    Re-verified, no change to tracked fields

    v12

  24. Notable

    Enrollment target: 225 to 500

    Primary completion date: Oct 2012 to Sep 2012; Completion date: Oct 2012 to Sep 2015; Study description revised; and 1 more

    Show all 5 changes in this update
    • Notable Enrollment target: 225 to 500
    • Minor Primary completion date: Oct 2012 to Sep 2012
    • Minor Completion date: Oct 2012 to Sep 2015
    • Minor Study description revised
      Show what changed
      [...] es. Research Plan: We propose a mobility outcome study with 225500 ankle osteoarthritis subjects who will undergo corrective s [...] dology: We propose a mobility outcome study with a total of 225500 ankle osteoarthritis subjects before and after surgery over [...] the questionnaires, subjects will be fit with the Stepwatch™ Activity Monitor (SAM, Cyma, Seattle WA) around their ankle [...]
    • Minor Site contact updated

    Study Status, Study Description, Study Design, Contacts/Locationsv11

  25. Minor

    Study description revised

    Collaborators: 2 to 3

    Show what changed: Study description
    [...] ompleting the questionnaires, subjects will be fit with the stepwatchtmStepwatch™ activityActivity monitorMonitor (SAM, Cyma, Seattle WA) around their ankle. An investigator [...] prior to surgical intervention and at 12, 24, and 36 months postoppost-op.
    Show what changed: Collaborators
    Minnesota Orthopedic Sports Medicine Institute Twin Cities Orthopedics (Edina, MN)

    Study Status, Sponsor/Collaborators, Study Descriptionv10

  26. Minor

    Study description expanded, about 1 word

    Show what changed: Study description
    [...] each of the treatments. Gait assessments will occur prior to surgical intervention and at 12, 24, and 36 months postop.

    Study Status, Study Descriptionv9

  27. Minor

    Study Status

    Re-verified, no change to tracked fields

    v8

  28. Minor

    Site contact updated

    Collaborators expanded, about 14 words

    Show what changed: Collaborators
    Orthopedic Associates of Grand Rapids (Grand Rapids, MI) Orthopedic + Fracture Specialists, Portland, OR

    Study Status, Sponsor/Collaborators, Contacts/Locationsv7

  29. Minor

    Site contact updated

    Study Status, Contacts/Locationsv6

  30. Notable

    Enrollment target: 120 to 225

    Study description shortened, about 114 words

    Show what changed: Study description
    [...] es. Research Plan: We propose a mobility outcome study with 120225 ankle osteoarthritis subjects who will undergo corrective s [...] dology: We propose a mobility outcome study with a total of 120225 ankle osteoarthritis subjects before and after surgery over the three years of the study (60 arthrodesis and 60 arthroplasty). Fifteen normal adults will also be tested. Ankle arthritis [...] r prior to intervention and at 12, 24, and 36 months postop. Metabolic domain: Gait efficiency will be assessed by measuring oxygen cost (ml/kg/m) during overground walking using a VmaxST portable metabolic device. Subject [...]

    Study Status, Study Description, Study Design, Arms and Interventionsv5

  31. Minor

    2 amendments

    2 re-verifications since 2008-09-05, no change to tracked fields

    v3-v4

  32. Notable

    Trial status: Not Yet Recruiting to Recruiting

    Enrollment target: 60 to 120; Primary completion date: Oct 2012; Eligibility criteria shortened, about 27 words; and 3 more

    Show all 7 changes in this update
    • Notable Trial status: Not Yet Recruiting to Recruiting
    • Notable Enrollment target: 60 to 120
    • Minor Primary completion date: Oct 2012
    • Minor Eligibility criteria shortened, about 27 words
      Show what changed
      [...] glish, are cognitively intact, and between the ages of 18-80 without additional gait-related co-morbidities. Exclusion Criteria: Suffer from Rheumatoid Arthritis or other systemic arthritis Have had any previous ankle arthroplasty or arthrodesis on one or both ankles. Have had any other significant injury to a lower extremity limb in the last two years Have any other diseased lower extremity joints or traumatic lower extremity injury that wouldgrossly preventinhibits ambulation.normal gait
    • Minor Study description shortened, about 6 words
      Show what changed
      [...] glish, are cognitively intact, and between the ages of 18-80 without additional gait-related co-morbidities. Recruitment, informed consent procedures and the experimen [...] arer. The SAM will be worn around the subject's ankle for 14-28 days, and then the subject will return the monitor and acti [...] F-36 will occur prior to surgical intervention and at 3, 6, 9, 12, 24 and 36 months following the intervention. Assessments [...] ng the SAM will occur prior to surgical intervention and at 63, 96, 12, 24 and 36 months following the intervention. These ass [...] s. Gait assessments will occur prior to intervention and at 6 [...] [...]
    • Minor Study site revised
      Show what changed
      VA Puget Sound Health Care System, Seattle
    • Minor Study arms: 0 to 2

    Study Status, Sponsor/Collaborators, Study Description, Conditions, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locationsv2

  1. Minor

    Study First Submitted

  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • 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 Osteoarthritis
Enrollment 368 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov