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Treatment Outcomes for Ankle Arthritis

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Orthopaedic Associates of Michigan (Grand Rapids, MI)
Orthopedic + Fracture Specialists, Portland, OR
Minnesota Orthopedic Sports Medicine Institute Twin Cities Orthopedics (Edina, MN)
Information provided by (Responsible Party):
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT00391365
First received: October 20, 2006
Last updated: July 21, 2016
Last verified: July 2016
  Purpose

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 recruiting new subjects but remains open for continued follow-up procedures and data analysis. All enrollment will be complete by August 2012.

As of July 2016 the study is currently analyzing data, and preparing a journal article for publication.


Condition Intervention
Osteoarthritis
Procedure: Gait analysis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Treatment Outcomes for Ankle Arthritis

Resource links provided by NLM:


Further study details as provided by VA Office of Research and Development:

Primary Outcome Measures:
  • Daily activity level measured by the Step Activity Monitor [ Time Frame: Over the course of 3 years ] [ Designated as safety issue: No ]
    Daily step counts recorded on StepWatch Activity Monitors (SAMs) Patient reported data on pain, function, disability, and satisfaction with surgery using the MFA, SF-36, and pain questionnaire.

  • Pain, Musculoskeletal Functional Assessment (MFA), SF-36 General Health Survey [ Time Frame: Over the course of 3 years ] [ Designated as safety issue: No ]
    Patient reported data on pain, function, disability and satisfaction with surgery using a pain questionnaire, MFA, and SF-36


Secondary Outcome Measures:
  • Gait analysis [ Time Frame: Over the course of three years ] [ Designated as safety issue: No ]

Biospecimen Retention:   None Retained
No biospecimens are used in this project

Enrollment: 358
Study Start Date: October 2006
Estimated Study Completion Date: July 2018
Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group 1
Subjects undergoing ankle arthrodesis (fusion) for treatment of ankle arthritis
Procedure: Gait analysis
Subjects will come into motion analysis laboratory at the VA Puget Sound Health Care System. A standard set of body measurements will be taken using calipers, a measuring tape, and a scale (for example height, weight, leg length, foot length, etc). The investigators will then attach small reflective markers to the body using double-sided tape and ask the participants to walk several times as the motion of each marker is recorded by infrared cameras.
Group 2
Subjects undergoing ankle arthroplasty (replacement) for treatment of ankle arthritis
Procedure: Gait analysis
Subjects will come into motion analysis laboratory at the VA Puget Sound Health Care System. A standard set of body measurements will be taken using calipers, a measuring tape, and a scale (for example height, weight, leg length, foot length, etc). The investigators will then attach small reflective markers to the body using double-sided tape and ask the participants to walk several times as the motion of each marker is recorded by infrared cameras.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 89 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects with ankle osteoarthritis who will undergo either ankle arthrodesis (fusion) or ankle arthroplasty (replacement)
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00391365

Locations
United States, Washington
VA Puget Sound Health Care System Seattle Division, Seattle, WA
Seattle, Washington, United States, 98108
Sponsors and Collaborators
VA Office of Research and Development
Orthopaedic Associates of Michigan (Grand Rapids, MI)
Orthopedic + Fracture Specialists, Portland, OR
Minnesota Orthopedic Sports Medicine Institute Twin Cities Orthopedics (Edina, MN)
Investigators
Principal Investigator: Bruce J Sangeorzan, MD VA Puget Sound Health Care System Seattle Division, Seattle, WA
  More Information

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00391365     History of Changes
Other Study ID Numbers: F4513-R 
Study First Received: October 20, 2006
Last Updated: July 21, 2016
Health Authority: United States: Federal Government
Individual Participant Data  
Plan to Share IPD: Undecided

Keywords provided by VA Office of Research and Development:
ankle osteoarthritis
arthritis
arthrodesis
arthroplasty
Gait
step count
walking

Additional relevant MeSH terms:
Arthritis
Osteoarthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on September 23, 2016