Treatment Outcomes for Ankle Arthritis
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Arthritis, Osteoarthritis (OA) |
| Therapuetic Areas: | Rheumatology |
| Healthy: | No |
| Age Range: | 18 - 89 |
| Updated: | 1/30/2019 |
| Start Date: | March 1, 2005 |
| End Date: | August 30, 2024 |
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, and preparing a journal article for
publication.
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.
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, and preparing a journal article for
publication.
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.
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.
Methodology:
The investigators propose a mobility outcome study with a total of up to 500 ankle
osteoarthritis subjects before and after surgery over the three years of the study. Ankle
arthritis subjects will be recruited from patients at the VA Puget Sound Health Care System
(Seattle, WA), Harborview Medical Center (Seattle, WA), Orthopedic + Fracture Specialists
(Portland, OR), Orthopaedic Associates of Michigan (Grand Rapids, MN), and Twin Cities
Orthopedics (Edina, MN) who have been diagnosed with end stage ankle arthrosis, are
ambulatory, speak English, are cognitively intact, and between the ages of 18-80.
Recruitment, informed consent procedures and the experimental protocol will be approved by
the Institutional Review Board (IRB) at each study site.
Since there is no clinical equipoise it would be unethical to randomize treatment at this
time. This project is an observational study of the outcomes following two common treatments:
Ankle arthrodesis (fusion) and ankle arthroplasty (total ankle joint replacement). The
outcomes will be assessed in two domains:
Functional domain: Each subject's functional status will be determined by the Musculoskeletal
Function Assessment (MFA) and the SF-36 general health survey. The MFA is a written
questionnaire that assesses activity and social limitations caused by musculoskeletal injury.
After completing the questionnaires, subjects will be fit with the Stepwatch Activity Monitor
(SAM, Cyma, Seattle WA) around their ankle. An investigator will give them verbal
instructions about wearing the SAM. This is a small, pager-sized device which counts the
number of steps taken by the wearer. The SAM will be worn around the subject's ankle for 14
days, and then the subject will return the monitor and activity log to the VA by visit or by
mail. Assessments using the MFA and SF-36 will 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 intervention and at 3,
6, 12, 24 and 36 months following the intervention. These assessments will provide data on
functional limitations due to ankle arthritis and on the efficacy of the treatments in
restoring functional ambulation.
Biomechanical domain: Instrumented gait analysis will be performed on each subject.
Reflective markers will be placed on each subject's head, hands, arms, trunk, legs, and feet.
The subject will walk along a 12 m walkway with embedded forceplates. The motion of the
markers will be collected with a 10 camera Vicon 612 system and processed to determine the
motion of the ankle joint in three planes as well as the moment and power generated by the
ankle during walking. This will allow us to assess the technical functional of the ankle
joint, the range of motion used during gait and the moment, power and energy contribution of
the ankle during walking for each of the treatments. Gait assessments will occur prior to
surgical intervention and at 12, 24, and 36 months post-op. Gait assessment takes place at
the VA Puget Sound Health Care System in Seattle, WA. The investigators will only recruit
subjects from the VA and Harborview Medical Center for the gait analysis portion of the
study.
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.
Methodology:
The investigators propose a mobility outcome study with a total of up to 500 ankle
osteoarthritis subjects before and after surgery over the three years of the study. Ankle
arthritis subjects will be recruited from patients at the VA Puget Sound Health Care System
(Seattle, WA), Harborview Medical Center (Seattle, WA), Orthopedic + Fracture Specialists
(Portland, OR), Orthopaedic Associates of Michigan (Grand Rapids, MN), and Twin Cities
Orthopedics (Edina, MN) who have been diagnosed with end stage ankle arthrosis, are
ambulatory, speak English, are cognitively intact, and between the ages of 18-80.
Recruitment, informed consent procedures and the experimental protocol will be approved by
the Institutional Review Board (IRB) at each study site.
Since there is no clinical equipoise it would be unethical to randomize treatment at this
time. This project is an observational study of the outcomes following two common treatments:
Ankle arthrodesis (fusion) and ankle arthroplasty (total ankle joint replacement). The
outcomes will be assessed in two domains:
Functional domain: Each subject's functional status will be determined by the Musculoskeletal
Function Assessment (MFA) and the SF-36 general health survey. The MFA is a written
questionnaire that assesses activity and social limitations caused by musculoskeletal injury.
After completing the questionnaires, subjects will be fit with the Stepwatch Activity Monitor
(SAM, Cyma, Seattle WA) around their ankle. An investigator will give them verbal
instructions about wearing the SAM. This is a small, pager-sized device which counts the
number of steps taken by the wearer. The SAM will be worn around the subject's ankle for 14
days, and then the subject will return the monitor and activity log to the VA by visit or by
mail. Assessments using the MFA and SF-36 will 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 intervention and at 3,
6, 12, 24 and 36 months following the intervention. These assessments will provide data on
functional limitations due to ankle arthritis and on the efficacy of the treatments in
restoring functional ambulation.
Biomechanical domain: Instrumented gait analysis will be performed on each subject.
Reflective markers will be placed on each subject's head, hands, arms, trunk, legs, and feet.
The subject will walk along a 12 m walkway with embedded forceplates. The motion of the
markers will be collected with a 10 camera Vicon 612 system and processed to determine the
motion of the ankle joint in three planes as well as the moment and power generated by the
ankle during walking. This will allow us to assess the technical functional of the ankle
joint, the range of motion used during gait and the moment, power and energy contribution of
the ankle during walking for each of the treatments. Gait assessments will occur prior to
surgical intervention and at 12, 24, and 36 months post-op. Gait assessment takes place at
the VA Puget Sound Health Care System in Seattle, WA. The investigators will only recruit
subjects from the VA and Harborview Medical Center for the gait analysis portion of the
study.
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
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