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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):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00391365
First received: October 20, 2006
Last updated: September 3, 2014
Last verified: September 2014
  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.


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 Department of Veterans Affairs:

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


Estimated Enrollment: 500
Study Start Date: October 2006
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: June 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). We will then attach small reflective markers to your body using double-sided tape and ask you 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). We will then attach small reflective markers to your body using double-sided tape and ask you 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
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

    • 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)
    • 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
Seattle, Washington, United States, 98108
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00391365     History of Changes
Other Study ID Numbers: F4513-R
Study First Received: October 20, 2006
Last Updated: September 3, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
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 November 25, 2014