Treatment Outcomes for Ankle Arthritis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 368
- Locations
- 1
- Primary Endpoint
- Musculoskeletal Functional Assessment (MFA)
Study Overview
Brief Summary
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.
Detailed Description
Project Objective:
Ankle osteoarthritis is characterized by joint pain, tenderness, limitation of movement, and variable degrees of inflammation. These factors combined and left untreated will severely limit a person's mobility and willingness to participate in activities. Two common surgical procedures chosen to alleviate pain and to increase mobility are ankle arthrodesis (ankle fusion) and arthroplasty (ankle replacement). Success rates for these procedures are variable and the amount of information available regarding long-term follow-up is limited. The extent to which a person is able and willing to move around the world is often an indicator of his/her condition. The proposed study will examine walking activity levels, and any difference in activity, in patients immediately before and after undergoing surgical treatment for ankle arthritis.
Successfully regaining motility is a priority for patients electing to have surgical treatment for ankle arthritis. A difference in activity levels would indicate an important outcome difference between surgical procedures.
Research Plan:
The investigators propose a mobility outcome study with up to 500 ankle osteoarthritis subjects who will undergo corrective surgery.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 89 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Group 1
Subjects undergoing ankle arthrodesis (fusion) for treatment of ankle arthritis
Intervention: Gait analysis (Procedure)
Group 2
Subjects undergoing ankle arthroplasty (replacement) for treatment of ankle arthritis
Intervention: Gait analysis (Procedure)
Outcomes
Primary Outcomes
Musculoskeletal Functional Assessment (MFA)
Time Frame: Over the course of 3 years
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.)
Secondary Outcomes
- Bodily Pain Section of Short Form-36 (SF-36)(Over the course of 3 years.)
- Physical Function Section of Short Form-36 (SF-36)(Over the course of 3 years.)