Trial Outcomes & Findings for Comparing Ankle Fusion to Ankle Replacement (NCT NCT01620541)
NCT ID: NCT01620541
Last Updated: 2026-08-21
Results Overview
Ankle specific function was assessed using the Foot and Ankle Ability Measure (FAAM) Activities of Daily Living (ADL) subscale, a validated, self-reported questionnaire which measures functional ability during activities of daily living. \[CH1.1\]The FAAM ADL subscale sums and coverts responses to a standardized score ranging from 0 to 100%. A score of 0% represents complete disability, and a score of 100% represents no functional limitations. Higher scores indicate better ankle function.
COMPLETED
517 participants
Before surgery, 1 year post-op, 2 years post-op, 4 years post-op, and 8 years post-op
2026-08-21
Participant Flow
Protocol Enrollment should be 517
Participant milestones
| Measure |
Preference, Ankle Arthrodesis
Participants received ankle arthrodesis to treat ESAA
|
Preference, Ankle Arthroplasty
Participants received ankle arthroplasty to treat ESAA
|
|---|---|---|
|
Overall Study
STARTED
|
103
|
414
|
|
Overall Study
COMPLETED
|
17
|
93
|
|
Overall Study
NOT COMPLETED
|
86
|
321
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparing Ankle Fusion to Ankle Replacement
Baseline characteristics by cohort
| Measure |
Preference, Ankle Arthrodesis
n=103 Participants
Participants received ankle arthrodesis to treat ESAA
|
Preference, Ankle Arthroplasty
n=414 Participants
Participants received ankle arthroplasty to treat ESAA
|
Total
n=517 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Age +/- (yr)
|
54.2 years
STANDARD_DEVIATION 12.7 • n=5 Participants
|
63.2 years
STANDARD_DEVIATION 9.7 • n=109 Participants
|
61.4 years
STANDARD_DEVIATION 10.9 • n=133 Participants
|
|
Sex/Gender, Customized
Male
|
61 Participants
n=5 Participants
|
237 Participants
n=109 Participants
|
298 Participants
n=133 Participants
|
|
Sex/Gender, Customized
Female
|
42 Participants
n=5 Participants
|
177 Participants
n=109 Participants
|
219 Participants
n=133 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
3 Participants
n=109 Participants
|
4 Participants
n=133 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
2 Participants
n=109 Participants
|
2 Participants
n=133 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=109 Participants
|
0 Participants
n=133 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
5 Participants
n=109 Participants
|
6 Participants
n=133 Participants
|
|
Race (NIH/OMB)
White
|
100 Participants
n=5 Participants
|
403 Participants
n=109 Participants
|
503 Participants
n=133 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=109 Participants
|
0 Participants
n=133 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=109 Participants
|
2 Participants
n=133 Participants
|
PRIMARY outcome
Timeframe: Before surgery, 1 year post-op, 2 years post-op, 4 years post-op, and 8 years post-opAnkle specific function was assessed using the Foot and Ankle Ability Measure (FAAM) Activities of Daily Living (ADL) subscale, a validated, self-reported questionnaire which measures functional ability during activities of daily living. \[CH1.1\]The FAAM ADL subscale sums and coverts responses to a standardized score ranging from 0 to 100%. A score of 0% represents complete disability, and a score of 100% represents no functional limitations. Higher scores indicate better ankle function.
Outcome measures
| Measure |
Preference, Ankle Arthroplasty
n=414 Participants
Participants received ankle arthroplasty to treat ESAA
|
Preference, Ankle Arthrodesis
n=103 Participants
Participants received ankle arthrodesis to treat ESAA
|
|---|---|---|
|
Change in Foot and Ankle Ability Measure (FAAM) Activities of Daily Living (ADL) Score Between Subjects Undergoing Ankle Arthrodesis and Total Ankle Arthroplasty
Pre-op
|
46.6 Scores on a scale
Standard Error 1.3
|
48.3 Scores on a scale
Standard Error 2
|
|
Change in Foot and Ankle Ability Measure (FAAM) Activities of Daily Living (ADL) Score Between Subjects Undergoing Ankle Arthrodesis and Total Ankle Arthroplasty
1 year
|
81.3 Scores on a scale
Standard Error 1.3
|
71.6 Scores on a scale
Standard Error 2
|
|
Change in Foot and Ankle Ability Measure (FAAM) Activities of Daily Living (ADL) Score Between Subjects Undergoing Ankle Arthrodesis and Total Ankle Arthroplasty
2 years
|
81.8 Scores on a scale
Standard Error 1.3
|
73.7 Scores on a scale
Standard Error 2
|
|
Change in Foot and Ankle Ability Measure (FAAM) Activities of Daily Living (ADL) Score Between Subjects Undergoing Ankle Arthrodesis and Total Ankle Arthroplasty
4 years
|
79.9 Scores on a scale
Standard Error 1.2
|
71.8 Scores on a scale
Standard Error 2
|
|
Change in Foot and Ankle Ability Measure (FAAM) Activities of Daily Living (ADL) Score Between Subjects Undergoing Ankle Arthrodesis and Total Ankle Arthroplasty
8 years
|
75.9 Scores on a scale
Standard Error 1.5
|
67.1 Scores on a scale
Standard Error 2.6
|
PRIMARY outcome
Timeframe: Before surgery, 1 year post-op, 2 years post-op, 4 years post-op, and 8 years post-opAnkle specific function during sports activities was measured using the Foot and Ankle Ability Measure (FAAM) Sports subscale, a validated, self-reported questionnaire which measures functional ability during sport-related activities. The FAAM Sports subscale sums and converts responses to a standardized score ranging from 0 to 100%. A score of 0% represents complete disability, and a score of 100% represents no functional limitations. Higher scores indicate better ankle function during sports activities.
Outcome measures
| Measure |
Preference, Ankle Arthroplasty
n=414 Participants
Participants received ankle arthroplasty to treat ESAA
|
Preference, Ankle Arthrodesis
n=103 Participants
Participants received ankle arthrodesis to treat ESAA
|
|---|---|---|
|
Change in Foot and Ankle Ability Measure (FAAM) Sports Subscale Between Subjects Undergoing Ankle Arthrodesis and Total Ankle Arthroplasty
Pre-op
|
19.6 Scores on a scale
Standard Error 1.9
|
21.8 Scores on a scale
Standard Error 2.9
|
|
Change in Foot and Ankle Ability Measure (FAAM) Sports Subscale Between Subjects Undergoing Ankle Arthrodesis and Total Ankle Arthroplasty
1 year
|
59.1 Scores on a scale
Standard Error 1.9
|
45.5 Scores on a scale
Standard Error 3
|
|
Change in Foot and Ankle Ability Measure (FAAM) Sports Subscale Between Subjects Undergoing Ankle Arthrodesis and Total Ankle Arthroplasty
2 years
|
59.7 Scores on a scale
Standard Error 1.9
|
52.3 Scores on a scale
Standard Error 2.9
|
|
Change in Foot and Ankle Ability Measure (FAAM) Sports Subscale Between Subjects Undergoing Ankle Arthrodesis and Total Ankle Arthroplasty
4 years
|
56.6 Scores on a scale
Standard Error 1.9
|
50.1 Scores on a scale
Standard Error 2.8
|
|
Change in Foot and Ankle Ability Measure (FAAM) Sports Subscale Between Subjects Undergoing Ankle Arthrodesis and Total Ankle Arthroplasty
8 years
|
49.3 Scores on a scale
Standard Error 2.2
|
46.1 Scores on a scale
Standard Error 3.9
|
PRIMARY outcome
Timeframe: Before surgery, 1 year post-op, 2 years post-op, 4 years post-op, and 8 years post-opAnkle specific function was assessed using the Short Form-36 (SF-36) Physical Component Summary (PCS) score, a validated, generic measure of health-related quality of life that evaluates physical health status. The PCS score is derived from responses to the SF-36 questionnaire and is norm-based, with scores ranging from 0-100, where higher scores indicate better physical health and lower scores indicate poorer physical health.
Outcome measures
| Measure |
Preference, Ankle Arthroplasty
n=414 Participants
Participants received ankle arthroplasty to treat ESAA
|
Preference, Ankle Arthrodesis
n=103 Participants
Participants received ankle arthrodesis to treat ESAA
|
|---|---|---|
|
Change in Short Form-36 (SF-36) Physical Component Summary (PCS) Score Between Subjects Undergoing Ankle Arthrodesis and Total Ankle Arthroplasty
8 years
|
43.2 Scores on a Scale
Standard Error 0.6
|
42.6 Scores on a Scale
Standard Error 1.2
|
|
Change in Short Form-36 (SF-36) Physical Component Summary (PCS) Score Between Subjects Undergoing Ankle Arthrodesis and Total Ankle Arthroplasty
Pre-op
|
34.2 Scores on a Scale
Standard Error 0.5
|
35.9 Scores on a Scale
Standard Error 0.9
|
|
Change in Short Form-36 (SF-36) Physical Component Summary (PCS) Score Between Subjects Undergoing Ankle Arthrodesis and Total Ankle Arthroplasty
1 year
|
46.9 Scores on a Scale
Standard Error 0.5
|
44.3 Scores on a Scale
Standard Error 1.0
|
|
Change in Short Form-36 (SF-36) Physical Component Summary (PCS) Score Between Subjects Undergoing Ankle Arthrodesis and Total Ankle Arthroplasty
2 years
|
46.6 Scores on a Scale
Standard Error 0.5
|
44.1 Scores on a Scale
Standard Error 0.9
|
|
Change in Short Form-36 (SF-36) Physical Component Summary (PCS) Score Between Subjects Undergoing Ankle Arthrodesis and Total Ankle Arthroplasty
4 years
|
45.3 Scores on a Scale
Standard Error 0.4
|
43.7 Scores on a Scale
Standard Error 0.9
|
PRIMARY outcome
Timeframe: Before surgery, 1 year post-op, 2 years post-op, 4 years post-op, and 8 years post-opPain was assessed using two questions from the Chronic Pain Grade (CPG), including intensity of worst pain in past 6 months. This was scored on a 0-10 point scale where higher scores represented greater pain (e.g., 0 = "no pain" and 10 = "pain as bad as it could be")
Outcome measures
| Measure |
Preference, Ankle Arthroplasty
n=414 Participants
Participants received ankle arthroplasty to treat ESAA
|
Preference, Ankle Arthrodesis
n=103 Participants
Participants received ankle arthrodesis to treat ESAA
|
|---|---|---|
|
Change in Overall Pain Intensity and Ankle Specific Pain Intensity; Interference With Activities in Subjects Undergoing Ankle Arthrodesis and Total Ankle Arthroplasty (Worst Pain)
Pre-op
|
8.5 Scores on a scale
Standard Error 0.2
|
8.3 Scores on a scale
Standard Error 0.3
|
|
Change in Overall Pain Intensity and Ankle Specific Pain Intensity; Interference With Activities in Subjects Undergoing Ankle Arthrodesis and Total Ankle Arthroplasty (Worst Pain)
1 year
|
3.6 Scores on a scale
Standard Error 0.2
|
4.2 Scores on a scale
Standard Error 0.3
|
|
Change in Overall Pain Intensity and Ankle Specific Pain Intensity; Interference With Activities in Subjects Undergoing Ankle Arthrodesis and Total Ankle Arthroplasty (Worst Pain)
2 years
|
3.1 Scores on a scale
Standard Error 0.2
|
4.0 Scores on a scale
Standard Error 0.3
|
|
Change in Overall Pain Intensity and Ankle Specific Pain Intensity; Interference With Activities in Subjects Undergoing Ankle Arthrodesis and Total Ankle Arthroplasty (Worst Pain)
4 years
|
3.2 Scores on a scale
Standard Error 0.2
|
3.8 Scores on a scale
Standard Error 0.3
|
|
Change in Overall Pain Intensity and Ankle Specific Pain Intensity; Interference With Activities in Subjects Undergoing Ankle Arthrodesis and Total Ankle Arthroplasty (Worst Pain)
8 years
|
3.1 Scores on a scale
Standard Error 0.2
|
3.4 Scores on a scale
Standard Error 0.4
|
PRIMARY outcome
Timeframe: Before surgery, 1 year post-op, 2 years post-op, 4 years post-op, and 8 years post-opPain was assessed using two questions from the Chronic Pain Grade (CPG), including intensity of average ankle pain in past 6 months. This was scored on a 0-10 point scale where higher scores represented greater pain (e.g., 0 = "no pain" and 10 = "pain as bad as it could be")
Outcome measures
| Measure |
Preference, Ankle Arthroplasty
n=414 Participants
Participants received ankle arthroplasty to treat ESAA
|
Preference, Ankle Arthrodesis
n=103 Participants
Participants received ankle arthrodesis to treat ESAA
|
|---|---|---|
|
Change in Overall Pain Intensity and Ankle Specific Pain Intensity; Interference With Activities in Subjects Undergoing Ankle Arthrodesis and Total Ankle Arthroplasty (Average Pain)
Pre-op
|
6.3 Scores on a scale
Standard Error 0.1
|
6 Scores on a scale
Standard Error 0.2
|
|
Change in Overall Pain Intensity and Ankle Specific Pain Intensity; Interference With Activities in Subjects Undergoing Ankle Arthrodesis and Total Ankle Arthroplasty (Average Pain)
1 year
|
2.1 Scores on a scale
Standard Error 0.1
|
2.7 Scores on a scale
Standard Error 0.2
|
|
Change in Overall Pain Intensity and Ankle Specific Pain Intensity; Interference With Activities in Subjects Undergoing Ankle Arthrodesis and Total Ankle Arthroplasty (Average Pain)
2 years
|
1.9 Scores on a scale
Standard Error 0.1
|
2.5 Scores on a scale
Standard Error 0.2
|
|
Change in Overall Pain Intensity and Ankle Specific Pain Intensity; Interference With Activities in Subjects Undergoing Ankle Arthrodesis and Total Ankle Arthroplasty (Average Pain)
4 years
|
2.0 Scores on a scale
Standard Error 0.1
|
2.5 Scores on a scale
Standard Error 0.2
|
|
Change in Overall Pain Intensity and Ankle Specific Pain Intensity; Interference With Activities in Subjects Undergoing Ankle Arthrodesis and Total Ankle Arthroplasty (Average Pain)
8 years
|
2.1 Scores on a scale
Standard Error 0.1
|
2.4 Scores on a scale
Standard Error 0.3
|
SECONDARY outcome
Timeframe: Assessed monthly until 12 months after surgeryPopulation: Sites attempted to record complications after 12 months but the tracking and reporting proved too difficult across sites to capture and summarize. Please see adverse events for details of the complications comparing arthroplasty to arthrodesis over the first 12 months after surgery.
Ankle-specific complications in the 12-month period post surgery
Outcome measures
| Measure |
Preference, Ankle Arthroplasty
n=414 Participants
Participants received ankle arthroplasty to treat ESAA
|
Preference, Ankle Arthrodesis
n=103 Participants
Participants received ankle arthrodesis to treat ESAA
|
|---|---|---|
|
Post-surgical Complication Rates
|
33 Participants
|
17 Participants
|
SECONDARY outcome
Timeframe: Before surgery and at 6, 12, and 24 months after surgeryPopulation: While change in step counts were an intended secondary outcome, unfortunately step counts were not collected as sites were unable to obtain step counters for patients.
Step counts using a StepWatch Activity Monitor, worn for a 7-14 day time period.
Outcome measures
Outcome data not reported
Adverse Events
Preference, Ankle Arthrodesis
Preference, Ankle Arthroplasty
Serious adverse events
| Measure |
Preference, Ankle Arthrodesis
n=103 participants at risk
Participants received ankle arthrodesis to treat ESAA
|
Preference, Ankle Arthroplasty
n=414 participants at risk
Participants received ankle arthroplasty to treat ESAA
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Major Surgical Revisions
|
3.9%
4/103 • from enrollment up to 12 months post-surgery
|
1.7%
7/414 • from enrollment up to 12 months post-surgery
|
Other adverse events
| Measure |
Preference, Ankle Arthrodesis
n=103 participants at risk
Participants received ankle arthrodesis to treat ESAA
|
Preference, Ankle Arthroplasty
n=414 participants at risk
Participants received ankle arthroplasty to treat ESAA
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Minor Surgical Revisions
|
8.7%
9/103 • from enrollment up to 12 months post-surgery
|
2.2%
9/414 • from enrollment up to 12 months post-surgery
|
|
Musculoskeletal and connective tissue disorders
Minor Adverse Event
|
3.9%
4/103 • from enrollment up to 12 months post-surgery
|
4.1%
17/414 • from enrollment up to 12 months post-surgery
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place