Trial Outcomes & Findings for Treatment Outcomes for Ankle Arthritis (NCT NCT00391365)
NCT ID: NCT00391365
Last Updated: 2026-01-26
Results Overview
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.)
COMPLETED
368 participants
Over the course of 3 years
2026-01-26
Participant Flow
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.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
103
|
170
|
|
Overall Study
COMPLETED
|
78
|
151
|
|
Overall Study
NOT COMPLETED
|
25
|
19
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Treatment Outcomes for Ankle Arthritis
Baseline characteristics by cohort
| Measure |
Ankle Arthrodesis (Fusion)
n=103 Participants
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.
|
Ankle Arthroplasty (Replacement)
n=170 Participants
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.
|
Total
n=273 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57.4 years
STANDARD_DEVIATION 11.4 • n=25 Participants
|
64.4 years
STANDARD_DEVIATION 9.3 • n=25 Participants
|
61.76 years
STANDARD_DEVIATION 10.68 • n=50 Participants
|
|
Sex: Female, Male
Female
|
42 Participants
n=25 Participants
|
81 Participants
n=25 Participants
|
123 Participants
n=50 Participants
|
|
Sex: Female, Male
Male
|
61 Participants
n=25 Participants
|
89 Participants
n=25 Participants
|
150 Participants
n=50 Participants
|
|
Region of Enrollment
United States
|
103 participants
n=25 Participants
|
170 participants
n=25 Participants
|
273 participants
n=50 Participants
|
PRIMARY outcome
Timeframe: Over the course of 3 yearsPopulation: 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.
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.)
Outcome measures
| Measure |
Ankle Arthrodesis (Fusion)
n=99 Participants
Subjects undergoing ankle arthrodesis (fusion) for treatment of ankle arthritis
|
Ankle Arthroplasty (Replacement)
n=165 Participants
Subjects undergoing ankle arthroplasty (replacement) for treatment of ankle arthritis
|
|---|---|---|
|
Musculoskeletal Functional Assessment (MFA)
|
-12.5 units on a scale
Standard Error 1.4
|
-15.0 units on a scale
Standard Error 0.9
|
SECONDARY outcome
Timeframe: 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.
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.)
Outcome measures
| Measure |
Ankle Arthrodesis (Fusion)
n=93 Participants
Subjects undergoing ankle arthrodesis (fusion) for treatment of ankle arthritis
|
Ankle Arthroplasty (Replacement)
n=157 Participants
Subjects undergoing ankle arthroplasty (replacement) for treatment of ankle arthritis
|
|---|---|---|
|
Physical Function Section of Short Form-36 (SF-36)
|
25.4 units on a scale
Standard Error 2.6
|
31.8 units on a scale
Standard Error 1.7
|
SECONDARY outcome
Timeframe: 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.
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.)
Outcome measures
| Measure |
Ankle Arthrodesis (Fusion)
n=93 Participants
Subjects undergoing ankle arthrodesis (fusion) for treatment of ankle arthritis
|
Ankle Arthroplasty (Replacement)
n=157 Participants
Subjects undergoing ankle arthroplasty (replacement) for treatment of ankle arthritis
|
|---|---|---|
|
Bodily Pain Section of Short Form-36 (SF-36)
|
35.3 units on a scale
Standard Error 2.9
|
34.8 units on a scale
Standard Error 2.0
|
Adverse Events
Ankle Arthrodesis (Fusion)
Ankle Arthroplasty (Replacement)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Alan Wesley, Program Manager
Center For Limb Loss Prevention and Prosthetic Engineering, VA Puget Sound Health Care System
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place