Osteoarthritis Clinical Trial
Official title:
Treatment Outcomes for Ankle Arthritis
Verified date | June 2024 |
Source | VA Office of Research and Development |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Active, not recruiting |
Enrollment | 368 |
Est. completion date | August 30, 2024 |
Est. primary completion date | August 1, 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 89 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | VA Puget Sound Health Care System Seattle Division, Seattle, WA | Seattle | Washington |
Lead Sponsor | Collaborator |
---|---|
VA Office of Research and Development | Minnesota Orthopedic Sports Medicine Institute Twin Cities Orthopedics (Edina, MN), Orthopaedic Associates of Michigan (Grand Rapids, MI), Orthopedic + Fracture Specialists, Portland, OR |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Musculoskeletal Functional Assessment (MFA) | Patient reported data using the MFA, a general functional assessment intended as a tool for evaluation of patients' perceptions of their physical, psychological, and social well-being that asks patients to assess their function on 100 items. Number shows change in outcome from pre-op to 3 years by surgery type, with a lower score implying an improved outcome (scale range 0 -100.) |
Over the course of 3 years | |
Secondary | Physical Function Section of Short Form-36 (SF-36) | Patient reported physical function data from the SF-36, a thirty-six item survey evolved from the RAND 36. Change in outcome from pre-op to 3 years by surgery type, with a higher score implying an improved outcome (scale range 0 - 100.) |
Over the course of 3 years. | |
Secondary | Bodily Pain Section of Short Form-36 (SF-36) | Patient reported bodily pain data from the SF-36, a thirty-six item survey evolved from the RAND 36. Number shows change in outcome from pre-op to 3 years by surgery type, with a higher score implying an improved outcome (scale range 0 - 100.) |
Over the course of 3 years. |
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