Osteoarthritis
Conditions
Keywords
ankle osteoarthritis, arthritis, arthrodesis, arthroplasty, Gait, step count, walking
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. 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.
Interventions
PROCEDUREGait 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.
Sponsors
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)
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 89 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Musculoskeletal Functional Assessment (MFA) | 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
| Measure | Time frame | Description |
|---|---|---|
| Physical Function Section of Short Form-36 (SF-36) | Over the course of 3 years. | 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.) |
| Bodily Pain Section of Short Form-36 (SF-36) | Over the course of 3 years. | 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.) |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORBruce J. Sangeorzan, MD
VA Puget Sound Health Care System Seattle Division, Seattle, WA
Participant flow
Recruitment details
474 patients were assessed for eligibility with 368 consenting to participate in the study. 95 subjects were excluded for various reasons (no surgery, non-compliant, etc.) resulting in 273 subjects actively participating. 229 subjects successively completed the Year 3 follow-up assessment.
Participants by arm
| Arm | Count |
|---|---|
| Ankle Arthrodesis (Fusion) Subjects undergoing ankle arthrodesis (fusion) for treatment of ankle arthritis
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. | 103 |
| Ankle Arthroplasty (Replacement) Subjects undergoing ankle arthroplasty (replacement) for treatment of ankle arthritis
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. | 170 |
| Total | 273 |
Baseline characteristics
| Characteristic | Ankle Arthrodesis (Fusion) | Ankle Arthroplasty (Replacement) | Total |
|---|---|---|---|
| Age, Continuous | 57.4 years STANDARD_DEVIATION 11.4 | 64.4 years STANDARD_DEVIATION 9.3 | 61.76 years STANDARD_DEVIATION 10.68 |
| Region of Enrollment United States | 103 participants | 170 participants | 273 participants |
| Sex: Female, Male Female | 42 Participants | 81 Participants | 123 Participants |
| Sex: Female, Male Male | 61 Participants | 89 Participants | 150 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
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.)
Time frame: Over the course of 3 years
Population: The study started with 103 subjects in the arthrodesis group, and 170 in the arthroplasty group. 78 subjects in the arthrodesis group completed the Year 3 assessment, and 151 in the arthroplasty group. Analysis was done on the MFA data collected from 99 arthrodesis subjects, and 165 arthroplasty subjects.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ankle Arthrodesis (Fusion) | Musculoskeletal Functional Assessment (MFA) | -12.5 units on a scale | Standard Error 1.4 |
| Ankle Arthroplasty (Replacement) | Musculoskeletal Functional Assessment (MFA) | -15.0 units on a scale | Standard Error 0.9 |
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.)
Time frame: Over the course of 3 years.
Population: The study started with 103 subjects in the arthrodesis group, and 170 in the arthroplasty group. 78 subjects in the arthrodesis group completed the Year 3 assessment, and 151 in the arthroplasty group. Analysis was done on the SF-36 bodily pain data collected from 93 arthrodesis subjects, and 157 arthroplasty subjects.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ankle Arthrodesis (Fusion) | Bodily Pain Section of Short Form-36 (SF-36) | 35.3 units on a scale | Standard Error 2.9 |
| Ankle Arthroplasty (Replacement) | Bodily Pain Section of Short Form-36 (SF-36) | 34.8 units on a scale | Standard Error 2 |
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.)
Time frame: Over the course of 3 years.
Population: The study started with 103 subjects in the arthrodesis group, and 170 in the arthroplasty group. 78 subjects in the arthrodesis group completed the Year 3 assessment, and 151 in the arthroplasty group. Analysis was done on the SF-36 physical function data collected from 93 arthrodesis subjects, and 157 arthroplasty subjects.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ankle Arthrodesis (Fusion) | Physical Function Section of Short Form-36 (SF-36) | 25.4 units on a scale | Standard Error 2.6 |
| Ankle Arthroplasty (Replacement) | Physical Function Section of Short Form-36 (SF-36) | 31.8 units on a scale | Standard Error 1.7 |