Trial Outcomes & Findings for Long Term Follow-up of Integra® Cadence™ Total Ankle System in Primary Ankle Joint Replacement (NCT NCT03247023)
NCT ID: NCT03247023
Last Updated: 2026-06-22
Results Overview
Implant survivorship determined by the percentage of participants with survival of the device. Successful device survival was defined as absence of device removal or revision.
TERMINATED
65 participants
2 years
2026-06-22
Participant Flow
Of the 65 participants enrolled, 4 participants were discontinued from the study due to screening failures with a total of 61 participants starting the study.
Participant milestones
| Measure |
Integra® Cadence™ Total Ankle System
Participants undergoing primary ankle arthroplasty with the Integra® Cadence™ Total Ankle System (CTAS)
|
|---|---|
|
Overall Study
STARTED
|
61
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
61
|
Reasons for withdrawal
| Measure |
Integra® Cadence™ Total Ankle System
Participants undergoing primary ankle arthroplasty with the Integra® Cadence™ Total Ankle System (CTAS)
|
|---|---|
|
Overall Study
Physician Decision
|
2
|
|
Overall Study
Death
|
1
|
|
Overall Study
Cancer
|
1
|
|
Overall Study
Study Termination (did not complete study exit form)
|
27
|
|
Overall Study
Study Termination (completed study exit form)
|
30
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Integra® Cadence™ Total Ankle System
n=61 Participants
Participants undergoing primary ankle arthroplasty with the Integra® Cadence™ Total Ankle System (CTAS)
|
|---|---|
|
Age, Continuous
|
61.6 years
STANDARD_DEVIATION 11.9 • n=61 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=61 Participants
|
|
Sex: Female, Male
Male
|
35 Participants
n=61 Participants
|
|
Body Mass Index (BMI)
|
28.5 kg/m^2
STANDARD_DEVIATION 4.4 • n=61 Participants
|
PRIMARY outcome
Timeframe: 2 yearsPopulation: The Safety Population (SAF) included participants that received the study device with data collected for the outcome and time frame specified.
Implant survivorship determined by the percentage of participants with survival of the device. Successful device survival was defined as absence of device removal or revision.
Outcome measures
| Measure |
Integra® Cadence™ Total Ankle System
n=52 Participants
Participants undergoing primary ankle arthroplasty with the Integra® Cadence™ Total Ankle System (CTAS)
|
|---|---|
|
Implant Survivorship at 2 Years
|
100 percentage of participants
Interval 93.2 to 100.0
|
SECONDARY outcome
Timeframe: 5 years and 10 yearsPopulation: The Safety Population (SAF) included participants that received the study device with data collected for the outcome and time frame specified. Due to early termination of the study, no participant reached the 10-year follow up visit and no data was collected for any participant beyond the 5-year follow up visit.
Implant survivorship at 5 years and 10 years was determined by the percentage of participants with device survival. Survivorship was measured using a Kaplan-Meier survival estimate with survival defined as absence of device removal or revision.
Outcome measures
| Measure |
Integra® Cadence™ Total Ankle System
n=8 Participants
Participants undergoing primary ankle arthroplasty with the Integra® Cadence™ Total Ankle System (CTAS)
|
|---|---|
|
Implant Survivorship at 5 Years and 10 Years
5 years · Yes
|
94.12 percentage of participants
Interval 65.02 to 99.15
|
SECONDARY outcome
Timeframe: Baseline, 3 months, 6 months, 1 year, 2 years, 5 yearsPopulation: The per-protocol (PP) included participants that satisfied all eligibility criteria without significant protocol deviations for the outcome and time frame specified. Due to early termination of the study, no participant reached the 10-year follow up visit and no data was collected for any participant beyond the 5-year follow up visit.
The PROMIS - Physical Function and Mobility score consisted of 15 components on a 5-point Likert scale. Responses were combined to produce a score that ranged from 0 to 100 where higher values represented higher mobility (i.e., a higher score was a better outcome).
Outcome measures
| Measure |
Integra® Cadence™ Total Ankle System
n=56 Participants
Participants undergoing primary ankle arthroplasty with the Integra® Cadence™ Total Ankle System (CTAS)
|
|---|---|
|
Patient Reported Outcomes Measurement Information System (PROMIS) Physical Function (PF) - Mobility
Baseline
|
41.5 score on a scale
Standard Deviation 17.13
|
|
Patient Reported Outcomes Measurement Information System (PROMIS) Physical Function (PF) - Mobility
3 months
|
58.1 score on a scale
Standard Deviation 22.85
|
|
Patient Reported Outcomes Measurement Information System (PROMIS) Physical Function (PF) - Mobility
6 months
|
67.9 score on a scale
Standard Deviation 24.26
|
|
Patient Reported Outcomes Measurement Information System (PROMIS) Physical Function (PF) - Mobility
1 year
|
75.6 score on a scale
Standard Deviation 20.31
|
|
Patient Reported Outcomes Measurement Information System (PROMIS) Physical Function (PF) - Mobility
2 years
|
76.4 score on a scale
Standard Deviation 23.16
|
|
Patient Reported Outcomes Measurement Information System (PROMIS) Physical Function (PF) - Mobility
5 years
|
68.6 score on a scale
Standard Deviation 27.12
|
SECONDARY outcome
Timeframe: Baseline, 3 months, 6 months, 1 year, 2 years, 5 yearsPopulation: The per-protocol (PP) included participants that satisfied all eligibility criteria without significant protocol deviations for the outcome and time frame specified. Due to early termination of the study, no participant reached the 10-year follow up visit and no data was collected for any participant beyond the 5-year follow up visit.
The Foot and Ankle Ability Measure (FAAM) Activities of Daily Living (ADL) Subscale scored 21 components on a 5-point Likert scale. Score totals ranged from 0 to 84 and were transformed to percentage scores with 100 representing no dysfunction (i.e., a higher score was a better outcome).
Outcome measures
| Measure |
Integra® Cadence™ Total Ankle System
n=56 Participants
Participants undergoing primary ankle arthroplasty with the Integra® Cadence™ Total Ankle System (CTAS)
|
|---|---|
|
Foot and Ankle Ability Measure (FAAM) Activities of Daily Living (ADL) Subscale
Baseline
|
48.4 score on a scale
Standard Deviation 16.32
|
|
Foot and Ankle Ability Measure (FAAM) Activities of Daily Living (ADL) Subscale
3 months
|
67.7 score on a scale
Standard Deviation 19.96
|
|
Foot and Ankle Ability Measure (FAAM) Activities of Daily Living (ADL) Subscale
6 months
|
76.6 score on a scale
Standard Deviation 17.25
|
|
Foot and Ankle Ability Measure (FAAM) Activities of Daily Living (ADL) Subscale
1 year
|
82.2 score on a scale
Standard Deviation 16.31
|
|
Foot and Ankle Ability Measure (FAAM) Activities of Daily Living (ADL) Subscale
2 years
|
81.9 score on a scale
Standard Deviation 18.44
|
|
Foot and Ankle Ability Measure (FAAM) Activities of Daily Living (ADL) Subscale
5 years
|
79.5 score on a scale
Standard Deviation 17.45
|
SECONDARY outcome
Timeframe: Baseline, 6 weeks, 3 months, 6 months, 1 year, 2 years, 5 yearsPopulation: The per-protocol (PP) included participants that satisfied all eligibility criteria without significant protocol deviations for the outcome and time frame specified. Due to early termination of the study, no participant reached the 10-year follow up visit and no data was collected for any participant beyond the 5-year follow up visit.
A Visual Analogue Scale (VAS) assessment was used to rate ankle pain while resting. The participant would indicate the level of pain by placing a vertical mark on a 100mm scale. Scores ranged from 0 to 100 with higher scores indicating a higher level of pain (i.e., a higher score was a worse outcome).
Outcome measures
| Measure |
Integra® Cadence™ Total Ankle System
n=58 Participants
Participants undergoing primary ankle arthroplasty with the Integra® Cadence™ Total Ankle System (CTAS)
|
|---|---|
|
Visual Analogue Scale (VAS) Pain Score: Resting
Baseline
|
42.5 score on a scale
Standard Deviation 26.53
|
|
Visual Analogue Scale (VAS) Pain Score: Resting
6 weeks
|
11.0 score on a scale
Standard Deviation 14.63
|
|
Visual Analogue Scale (VAS) Pain Score: Resting
3 months
|
10.8 score on a scale
Standard Deviation 13.33
|
|
Visual Analogue Scale (VAS) Pain Score: Resting
6 months
|
10.2 score on a scale
Standard Deviation 14.55
|
|
Visual Analogue Scale (VAS) Pain Score: Resting
1 year
|
6.3 score on a scale
Standard Deviation 9.10
|
|
Visual Analogue Scale (VAS) Pain Score: Resting
2 years
|
8.3 score on a scale
Standard Deviation 11.57
|
|
Visual Analogue Scale (VAS) Pain Score: Resting
5 years
|
13.3 score on a scale
Standard Deviation 15.54
|
SECONDARY outcome
Timeframe: Baseline, 3 months, 6 months, 1 year, 2 years, 5 yearsPopulation: The per-protocol (PP) included participants that satisfied all eligibility criteria without significant protocol deviations for the outcome and time frame specified. Due to early termination of the study, no participant reached the 10-year follow up visit and no data was collected for any participant beyond the 5-year follow up visit.
A Visual Analogue Scale (VAS) assessment was used to rate ankle pain while during activity. The participant would indicate the level of pain by placing a vertical mark on a 100mm scale. Scores ranged from 0 to 100 with higher scores indicating a higher level of pain (i.e., a higher score was a worse outcome).
Outcome measures
| Measure |
Integra® Cadence™ Total Ankle System
n=58 Participants
Participants undergoing primary ankle arthroplasty with the Integra® Cadence™ Total Ankle System (CTAS)
|
|---|---|
|
Visual Analogue Scale (VAS) Pain Score: Activity
Baseline
|
73.1 score on a scale
Standard Deviation 18.18
|
|
Visual Analogue Scale (VAS) Pain Score: Activity
3 months
|
33.1 score on a scale
Standard Deviation 24.63
|
|
Visual Analogue Scale (VAS) Pain Score: Activity
6 months
|
23.9 score on a scale
Standard Deviation 23.46
|
|
Visual Analogue Scale (VAS) Pain Score: Activity
1 year
|
19.1 score on a scale
Standard Deviation 20.02
|
|
Visual Analogue Scale (VAS) Pain Score: Activity
2 years
|
22.6 score on a scale
Standard Deviation 24.27
|
|
Visual Analogue Scale (VAS) Pain Score: Activity
5 years
|
26.1 score on a scale
Standard Deviation 31.35
|
SECONDARY outcome
Timeframe: Baseline, 3 months, 6 months, 1 year, 2 years, 5 yearsPopulation: The per-protocol (PP) included participants that satisfied all eligibility criteria without significant protocol deviations for the outcome and time frame specified. Due to early termination of the study, no participant reached the 10-year follow up visit and no data was collected for any participant beyond the 5-year follow up visit.
The SF-36v2 Health Survey is composed of 36 questions across 8 domains. The Physical Functioning domain focused on limitations in daily activities like running, climbing stairs, bending, or walking. Scores ranged from 0 to 100 with lower scores indicating greater physical disability (i.e., a higher score was a better outcome).
Outcome measures
| Measure |
Integra® Cadence™ Total Ankle System
n=58 Participants
Participants undergoing primary ankle arthroplasty with the Integra® Cadence™ Total Ankle System (CTAS)
|
|---|---|
|
Short Form-36 Version 2 Health Survey (SF-36v2): Physical Functioning
Baseline
|
38.6 score on a scale
Standard Deviation 21.37
|
|
Short Form-36 Version 2 Health Survey (SF-36v2): Physical Functioning
3 months
|
53.9 score on a scale
Standard Deviation 26.68
|
|
Short Form-36 Version 2 Health Survey (SF-36v2): Physical Functioning
6 months
|
63.9 score on a scale
Standard Deviation 26.89
|
|
Short Form-36 Version 2 Health Survey (SF-36v2): Physical Functioning
1 year
|
69.7 score on a scale
Standard Deviation 25.88
|
|
Short Form-36 Version 2 Health Survey (SF-36v2): Physical Functioning
2 years
|
67.2 score on a scale
Standard Deviation 26.90
|
|
Short Form-36 Version 2 Health Survey (SF-36v2): Physical Functioning
5 years
|
61.4 score on a scale
Standard Deviation 31.19
|
SECONDARY outcome
Timeframe: Baseline, 3 months, 6 months, 1 year, 2 years, 5 yearsPopulation: The per-protocol (PP) included participants that satisfied all eligibility criteria without significant protocol deviations for the outcome and time frame specified. Due to early termination of the study, no participant reached the 10-year follow up visit and no data was collected for any participant beyond the 5-year follow up visit.
The SF-36v2 Health Survey is composed of 36 questions across 8 domains. The Role Limitations Due to Physical Health domain focused on limitations in work or other regular daily activities as a result of their physical health. Scores ranged from 0 to 100 with lower scores indicating greater limitation (i.e., a higher score was a better outcome).
Outcome measures
| Measure |
Integra® Cadence™ Total Ankle System
n=58 Participants
Participants undergoing primary ankle arthroplasty with the Integra® Cadence™ Total Ankle System (CTAS)
|
|---|---|
|
Short Form-36 Version 2 Health Survey (SF-36v2): Role Limitations Due to Physical Health
Baseline
|
41.6 score on a scale
Standard Deviation 25.31
|
|
Short Form-36 Version 2 Health Survey (SF-36v2): Role Limitations Due to Physical Health
3 months
|
50.5 score on a scale
Standard Deviation 31.98
|
|
Short Form-36 Version 2 Health Survey (SF-36v2): Role Limitations Due to Physical Health
6 months
|
63.7 score on a scale
Standard Deviation 29.58
|
|
Short Form-36 Version 2 Health Survey (SF-36v2): Role Limitations Due to Physical Health
1 year
|
69.8 score on a scale
Standard Deviation 29.37
|
|
Short Form-36 Version 2 Health Survey (SF-36v2): Role Limitations Due to Physical Health
2 years
|
67.4 score on a scale
Standard Deviation 24.84
|
|
Short Form-36 Version 2 Health Survey (SF-36v2): Role Limitations Due to Physical Health
5 years
|
54.5 score on a scale
Standard Deviation 31.41
|
SECONDARY outcome
Timeframe: Baseline, 3 months, 6 months, 1 year, 2 years, 5 yearsPopulation: The per-protocol (PP) included participants that satisfied all eligibility criteria without significant protocol deviations for the outcome and time frame specified. Due to early termination of the study, no participant reached the 10-year follow up visit and no data was collected for any participant beyond the 5-year follow up visit.
The SF-36v2 Health Survey is composed of 36 questions across 8 domains. The Role Limitations Due to Emotional Problems domain focused on limitations in work or other regular daily activities as a result of any emotional problems such as feeling depressed or anxious. Scores ranged from 0 to 100 with lower scores indicating greater limitation (i.e., a higher score was a better outcome).
Outcome measures
| Measure |
Integra® Cadence™ Total Ankle System
n=58 Participants
Participants undergoing primary ankle arthroplasty with the Integra® Cadence™ Total Ankle System (CTAS)
|
|---|---|
|
Short Form-36 Version 2 Health Survey (SF-36v2): Role Limitations Due to Emotional Problems
Baseline
|
63.8 score on a scale
Standard Deviation 30.21
|
|
Short Form-36 Version 2 Health Survey (SF-36v2): Role Limitations Due to Emotional Problems
3 months
|
73.3 score on a scale
Standard Deviation 29.73
|
|
Short Form-36 Version 2 Health Survey (SF-36v2): Role Limitations Due to Emotional Problems
6 months
|
72.7 score on a scale
Standard Deviation 29.07
|
|
Short Form-36 Version 2 Health Survey (SF-36v2): Role Limitations Due to Emotional Problems
1 year
|
78.6 score on a scale
Standard Deviation 26.49
|
|
Short Form-36 Version 2 Health Survey (SF-36v2): Role Limitations Due to Emotional Problems
2 years
|
80.2 score on a scale
Standard Deviation 23.36
|
|
Short Form-36 Version 2 Health Survey (SF-36v2): Role Limitations Due to Emotional Problems
5 years
|
71.4 score on a scale
Standard Deviation 23.02
|
SECONDARY outcome
Timeframe: Baseline, 3 months, 6 months, 1 year, 2 years, 5 yearsPopulation: The per-protocol (PP) included participants that satisfied all eligibility criteria without significant protocol deviations for the outcome and time frame specified. Due to early termination of the study, no participant reached the 10-year follow up visit and no data was collected for any participant beyond the 5-year follow up visit.
The SF-36v2 Health Survey is composed of 36 questions across 8 domains. The Energy/Fatigue domain focused on feelings of energy, tiredness, and being worn out over the past four weeks. Scores ranged from 0 to 100 with lower scores indicating less energy and more fatigue (i.e., a higher score was a better outcome).
Outcome measures
| Measure |
Integra® Cadence™ Total Ankle System
n=58 Participants
Participants undergoing primary ankle arthroplasty with the Integra® Cadence™ Total Ankle System (CTAS)
|
|---|---|
|
Short Form-36 Version 2 Health Survey (SF-36v2): Energy/Fatigue
Baseline
|
50.6 score on a scale
Standard Deviation 12.41
|
|
Short Form-36 Version 2 Health Survey (SF-36v2): Energy/Fatigue
3 months
|
49.6 score on a scale
Standard Deviation 7.17
|
|
Short Form-36 Version 2 Health Survey (SF-36v2): Energy/Fatigue
6 months
|
50.6 score on a scale
Standard Deviation 8.86
|
|
Short Form-36 Version 2 Health Survey (SF-36v2): Energy/Fatigue
1 year
|
52.6 score on a scale
Standard Deviation 7.67
|
|
Short Form-36 Version 2 Health Survey (SF-36v2): Energy/Fatigue
2 years
|
52.8 score on a scale
Standard Deviation 6.09
|
|
Short Form-36 Version 2 Health Survey (SF-36v2): Energy/Fatigue
5 years
|
58.1 score on a scale
Standard Deviation 7.83
|
SECONDARY outcome
Timeframe: Baseline, 3 months, 6 months, 1 year, 2 years, 5 yearsPopulation: The per-protocol (PP) included participants that satisfied all eligibility criteria without significant protocol deviations for the outcome and time frame specified. Due to early termination of the study, no participant reached the 10-year follow up visit and no data was collected for any participant beyond the 5-year follow up visit.
The SF-36v2 Health Survey is composed of 36 questions across 8 domains. The Emotional Well-being domain focused on feelings of their mental health over the past four weeks. Scores ranged from 0 to 100 with lower scores indicating poor emotional well-being (i.e., a higher score was a better outcome).
Outcome measures
| Measure |
Integra® Cadence™ Total Ankle System
n=58 Participants
Participants undergoing primary ankle arthroplasty with the Integra® Cadence™ Total Ankle System (CTAS)
|
|---|---|
|
Short Form-36 Version 2 Health Survey (SF-36v2): Emotional Well-being
Baseline
|
41.9 score on a scale
Standard Deviation 11.54
|
|
Short Form-36 Version 2 Health Survey (SF-36v2): Emotional Well-being
3 months
|
40.5 score on a scale
Standard Deviation 7.66
|
|
Short Form-36 Version 2 Health Survey (SF-36v2): Emotional Well-being
6 months
|
38.6 score on a scale
Standard Deviation 8.41
|
|
Short Form-36 Version 2 Health Survey (SF-36v2): Emotional Well-being
1 year
|
39.9 score on a scale
Standard Deviation 8.42
|
|
Short Form-36 Version 2 Health Survey (SF-36v2): Emotional Well-being
2 years
|
41.1 score on a scale
Standard Deviation 9.54
|
|
Short Form-36 Version 2 Health Survey (SF-36v2): Emotional Well-being
5 years
|
43.6 score on a scale
Standard Deviation 6.90
|
SECONDARY outcome
Timeframe: Baseline, 3 months, 6 months, 1 year, 2 years, 5 yearsPopulation: The per-protocol (PP) included participants that satisfied all eligibility criteria without significant protocol deviations for the outcome and time frame specified. Due to early termination of the study, no participant reached the 10-year follow up visit and no data was collected for any participant beyond the 5-year follow up visit.
The SF-36v2 Health Survey is composed of 36 questions across 8 domains. The Social Functioning domain focused on how physical health or emotional problems interfered with their social activities (like visiting with friends, relatives, etc.). Scores ranged from 0 to 100 with lower scores indicating greater disfunction (i.e., a higher score was a better outcome).
Outcome measures
| Measure |
Integra® Cadence™ Total Ankle System
n=58 Participants
Participants undergoing primary ankle arthroplasty with the Integra® Cadence™ Total Ankle System (CTAS)
|
|---|---|
|
Short Form-36 Version 2 Health Survey (SF-36v2): Social Functioning
Baseline
|
61.9 score on a scale
Standard Deviation 26.33
|
|
Short Form-36 Version 2 Health Survey (SF-36v2): Social Functioning
3 months
|
75.9 score on a scale
Standard Deviation 24.26
|
|
Short Form-36 Version 2 Health Survey (SF-36v2): Social Functioning
6 months
|
83.2 score on a scale
Standard Deviation 22.34
|
|
Short Form-36 Version 2 Health Survey (SF-36v2): Social Functioning
1 year
|
79.5 score on a scale
Standard Deviation 24.58
|
|
Short Form-36 Version 2 Health Survey (SF-36v2): Social Functioning
2 years
|
82.4 score on a scale
Standard Deviation 20.88
|
|
Short Form-36 Version 2 Health Survey (SF-36v2): Social Functioning
5 years
|
82.1 score on a scale
Standard Deviation 28.74
|
SECONDARY outcome
Timeframe: Baseline, 3 months, 6 months, 1 year, 2 years, 5 yearsPopulation: The per-protocol (PP) included participants that satisfied all eligibility criteria without significant protocol deviations for the outcome and time frame specified. Due to early termination of the study, no participant reached the 10-year follow up visit and no data was collected for any participant beyond the 5-year follow up visit.
The SF-36v2 Health Survey is composed of 36 questions across 8 domains. The Pain domain focused on how much pain affected daily activities over the last four weeks. Scores ranged from 0 to 100 with lower scores indicating more pain (i.e., a higher score was a better outcome).
Outcome measures
| Measure |
Integra® Cadence™ Total Ankle System
n=58 Participants
Participants undergoing primary ankle arthroplasty with the Integra® Cadence™ Total Ankle System (CTAS)
|
|---|---|
|
Short Form-36 Version 2 Health Survey (SF-36v2): Pain
Baseline
|
36.8 score on a scale
Standard Deviation 18.77
|
|
Short Form-36 Version 2 Health Survey (SF-36v2): Pain
3 months
|
58.3 score on a scale
Standard Deviation 19.85
|
|
Short Form-36 Version 2 Health Survey (SF-36v2): Pain
6 months
|
66.5 score on a scale
Standard Deviation 22.62
|
|
Short Form-36 Version 2 Health Survey (SF-36v2): Pain
1 year
|
66.9 score on a scale
Standard Deviation 28.22
|
|
Short Form-36 Version 2 Health Survey (SF-36v2): Pain
2 years
|
67.6 score on a scale
Standard Deviation 24.51
|
|
Short Form-36 Version 2 Health Survey (SF-36v2): Pain
5 years
|
43.9 score on a scale
Standard Deviation 27.61
|
SECONDARY outcome
Timeframe: Baseline, 3 months, 6 months, 1 year, 2 years, 5 yearsPopulation: The per-protocol (PP) included participants that satisfied all eligibility criteria without significant protocol deviations for the outcome and time frame specified. Due to early termination of the study, no participant reached the 10-year follow up visit and no data was collected for any participant beyond the 5-year follow up visit.
The SF-36v2 Health Survey is composed of 36 questions across 8 domains. The General Health domain focused on perception of overall health and health change over time. Scores ranged from 0 to 100 with lower scores indicating worse health (i.e., a higher score was a better outcome).
Outcome measures
| Measure |
Integra® Cadence™ Total Ankle System
n=58 Participants
Participants undergoing primary ankle arthroplasty with the Integra® Cadence™ Total Ankle System (CTAS)
|
|---|---|
|
Short Form-36 Version 2 Health Survey (SF-36v2): General Health
Baseline
|
53.6 score on a scale
Standard Deviation 9.39
|
|
Short Form-36 Version 2 Health Survey (SF-36v2): General Health
3 months
|
57.9 score on a scale
Standard Deviation 10.87
|
|
Short Form-36 Version 2 Health Survey (SF-36v2): General Health
6 months
|
56.5 score on a scale
Standard Deviation 11.32
|
|
Short Form-36 Version 2 Health Survey (SF-36v2): General Health
1 year
|
59.3 score on a scale
Standard Deviation 10.82
|
|
Short Form-36 Version 2 Health Survey (SF-36v2): General Health
2 years
|
57.0 score on a scale
Standard Deviation 10.52
|
|
Short Form-36 Version 2 Health Survey (SF-36v2): General Health
5 years
|
57.6 score on a scale
Standard Deviation 19.16
|
SECONDARY outcome
Timeframe: Baseline, 3 months, 6 months, 1 year, 2 years, 5 yearsPopulation: The per-protocol (PP) included participants that satisfied all eligibility criteria without significant protocol deviations for the outcome and time frame specified. Due to early termination of the study, no participant reached the 10-year follow up visit and no data was collected for any participant beyond the 5-year follow up visit.
The SF-36v2 Health Survey is composed of 36 questions across 8 domains. The Physical Component score combined scores from the Physical Functioning, Role Limitations Due to Physical Health, Pain, and General Health domains. Scores ranged from 0 to 100 with lower scores indicating worse physical health (i.e., a higher score was a better outcome).
Outcome measures
| Measure |
Integra® Cadence™ Total Ankle System
n=58 Participants
Participants undergoing primary ankle arthroplasty with the Integra® Cadence™ Total Ankle System (CTAS)
|
|---|---|
|
Short Form-36 Version 2 Health Survey (SF-36v2): Physical Component Score
Baseline
|
42.6 score on a scale
Standard Deviation 14.41
|
|
Short Form-36 Version 2 Health Survey (SF-36v2): Physical Component Score
3 months
|
55.1 score on a scale
Standard Deviation 18.54
|
|
Short Form-36 Version 2 Health Survey (SF-36v2): Physical Component Score
6 months
|
62.6 score on a scale
Standard Deviation 19.30
|
|
Short Form-36 Version 2 Health Survey (SF-36v2): Physical Component Score
1 year
|
66.4 score on a scale
Standard Deviation 20.77
|
|
Short Form-36 Version 2 Health Survey (SF-36v2): Physical Component Score
2 years
|
64.8 score on a scale
Standard Deviation 17.70
|
|
Short Form-36 Version 2 Health Survey (SF-36v2): Physical Component Score
5 years
|
54.4 score on a scale
Standard Deviation 24.14
|
SECONDARY outcome
Timeframe: Baseline, 3 months, 6 months, 1 year, 2 years, 5 yearsPopulation: The per-protocol (PP) included participants that satisfied all eligibility criteria without significant protocol deviations for the outcome and time frame specified. Due to early termination of the study, no participant reached the 10-year follow up visit and no data was collected for any participant beyond the 5-year follow up visit.
The SF-36v2 Health Survey is composed of 36 questions across 8 domains. The Physical Component score combined scores from the Role Limitations Due to Emotional Problems, Energy/Fatigue, Emotional Well-being, and Social Functioning domains. Scores ranged from 0 to 100 with lower scores indicating worse mental health (i.e., a higher score was a better outcome).
Outcome measures
| Measure |
Integra® Cadence™ Total Ankle System
n=58 Participants
Participants undergoing primary ankle arthroplasty with the Integra® Cadence™ Total Ankle System (CTAS)
|
|---|---|
|
Short Form-36 Version 2 Health Survey (SF-36v2): Mental Component Score
Baseline
|
54.5 score on a scale
Standard Deviation 13.31
|
|
Short Form-36 Version 2 Health Survey (SF-36v2): Mental Component Score
3 months
|
59.8 score on a scale
Standard Deviation 12.38
|
|
Short Form-36 Version 2 Health Survey (SF-36v2): Mental Component Score
6 months
|
61.3 score on a scale
Standard Deviation 11.78
|
|
Short Form-36 Version 2 Health Survey (SF-36v2): Mental Component Score
1 year
|
62.7 score on a scale
Standard Deviation 11.61
|
|
Short Form-36 Version 2 Health Survey (SF-36v2): Mental Component Score
2 years
|
64.1 score on a scale
Standard Deviation 9.20
|
|
Short Form-36 Version 2 Health Survey (SF-36v2): Mental Component Score
5 years
|
63.8 score on a scale
Standard Deviation 12.23
|
SECONDARY outcome
Timeframe: 6 weeks, 3 months, 6 months, 1 year, 2 years, 5 yearsPopulation: The Safety Population (SAF) included participants that received the study device with data collected for the outcome and time frame specified. Due to early termination of the study, no participant reached the 10-year follow up visit and no data was collected for any participant beyond the 5-year follow up visit.
The number of participants with radiographic success were categorized as either 'Fail' or 'Success'. Success was defined as absence of implant radiolucency, subsidence, tilting, and/or migration with failure specifically defined as occurring if: 1. ≥3 of the 20 radiolucency zones had \>4mm in width, OR 2. device tilting = present, OR 3. device subsidence (tibial OR talar) = \>4mm, OR 4. device migration (tibial OR talar) = \>4mm
Outcome measures
| Measure |
Integra® Cadence™ Total Ankle System
n=60 Participants
Participants undergoing primary ankle arthroplasty with the Integra® Cadence™ Total Ankle System (CTAS)
|
|---|---|
|
Radiographic Success
6 weeks · Fail
|
0 Participants
|
|
Radiographic Success
6 weeks · Success
|
46 Participants
|
|
Radiographic Success
3 months · Fail
|
0 Participants
|
|
Radiographic Success
3 months · Success
|
59 Participants
|
|
Radiographic Success
6 months · Fail
|
0 Participants
|
|
Radiographic Success
6 months · Success
|
60 Participants
|
|
Radiographic Success
1 year · Fail
|
0 Participants
|
|
Radiographic Success
1 year · Success
|
57 Participants
|
|
Radiographic Success
2 years · Fail
|
3 Participants
|
|
Radiographic Success
2 years · Success
|
45 Participants
|
|
Radiographic Success
5 years · Fail
|
1 Participants
|
|
Radiographic Success
5 years · Success
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline, 1 year, 2 yearsPopulation: The Safety Population (SAF) included participants that received the study device with data collected for the outcome and time frame specified.
Range of motion measurements for ankle dorsiflexion and ankle plantarflexion in degrees were derived from radiographs in positions of maximum plantarflexion and dorsiflexion.
Outcome measures
| Measure |
Integra® Cadence™ Total Ankle System
n=61 Participants
Participants undergoing primary ankle arthroplasty with the Integra® Cadence™ Total Ankle System (CTAS)
|
|---|---|
|
Radiographic Assessment: Ankle Dorsiflexion and Plantarflexion Range of Motion
Ankle Dorsiflexion: Baseline
|
10.6 degrees
Standard Deviation 11.35
|
|
Radiographic Assessment: Ankle Dorsiflexion and Plantarflexion Range of Motion
Ankle Dorsiflexion: 1 year
|
4.7 degrees
Standard Deviation 11.76
|
|
Radiographic Assessment: Ankle Dorsiflexion and Plantarflexion Range of Motion
Ankle Dorsiflexion: 2 years
|
2.3 degrees
Standard Deviation 10.54
|
|
Radiographic Assessment: Ankle Dorsiflexion and Plantarflexion Range of Motion
Ankle Plantarflexion: Baseline
|
31.1 degrees
Standard Deviation 11.58
|
|
Radiographic Assessment: Ankle Dorsiflexion and Plantarflexion Range of Motion
Ankle Plantarflexion: 1 year
|
27.1 degrees
Standard Deviation 11.40
|
|
Radiographic Assessment: Ankle Dorsiflexion and Plantarflexion Range of Motion
Ankle Plantarflexion: 2 years
|
23.7 degrees
Standard Deviation 9.58
|
SECONDARY outcome
Timeframe: Baseline, 1 year, 2 yearsPopulation: The Safety Population (SAF) included participants that received the study device with data collected for the outcome and time frame specified.
Range of motion measurements were derived from radiographs in positions of maximum plantarflexion and dorsiflexion. Tibiotalar range of motion in degrees was calculated as the difference between the ankle dorsiflexion and ankle plantarflexion angles.
Outcome measures
| Measure |
Integra® Cadence™ Total Ankle System
n=60 Participants
Participants undergoing primary ankle arthroplasty with the Integra® Cadence™ Total Ankle System (CTAS)
|
|---|---|
|
Radiographic Assessment: Tibiotalar Range of Motion
2 years
|
21.4 degrees
Standard Deviation 10.01
|
|
Radiographic Assessment: Tibiotalar Range of Motion
Baseline
|
20.0 degrees
Standard Deviation 12.10
|
|
Radiographic Assessment: Tibiotalar Range of Motion
1 year
|
22.5 degrees
Standard Deviation 11.28
|
Adverse Events
Integra® Cadence™ Total Ankle System
Serious adverse events
| Measure |
Integra® Cadence™ Total Ankle System
n=61 participants at risk
Participants undergoing primary ankle arthroplasty with the Integra® Cadence™ Total Ankle System (CTAS)
|
|---|---|
|
General disorders
Deformity/ Disfigurement
|
1.6%
1/61 • Adverse events were collected upon implantation of the study device to early study termination, up to 5 years.
Ascension Orthopedics Inc. conducted monitoring \& reporting responsibilities from study start to December 2020. Upon acquisition, Smith+Nephew's Adverse Event Monitoring Board (AEMB) reviewed \& classified all adverse events from January 2021 to study termination, following ISO 14155 guidelines.
|
|
General disorders
Necrosis
|
1.6%
1/61 • Adverse events were collected upon implantation of the study device to early study termination, up to 5 years.
Ascension Orthopedics Inc. conducted monitoring \& reporting responsibilities from study start to December 2020. Upon acquisition, Smith+Nephew's Adverse Event Monitoring Board (AEMB) reviewed \& classified all adverse events from January 2021 to study termination, following ISO 14155 guidelines.
|
|
General disorders
Pain
|
3.3%
2/61 • Adverse events were collected upon implantation of the study device to early study termination, up to 5 years.
Ascension Orthopedics Inc. conducted monitoring \& reporting responsibilities from study start to December 2020. Upon acquisition, Smith+Nephew's Adverse Event Monitoring Board (AEMB) reviewed \& classified all adverse events from January 2021 to study termination, following ISO 14155 guidelines.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
3.3%
2/61 • Adverse events were collected upon implantation of the study device to early study termination, up to 5 years.
Ascension Orthopedics Inc. conducted monitoring \& reporting responsibilities from study start to December 2020. Upon acquisition, Smith+Nephew's Adverse Event Monitoring Board (AEMB) reviewed \& classified all adverse events from January 2021 to study termination, following ISO 14155 guidelines.
|
|
Musculoskeletal and connective tissue disorders
Limb Fracture
|
11.5%
7/61 • Adverse events were collected upon implantation of the study device to early study termination, up to 5 years.
Ascension Orthopedics Inc. conducted monitoring \& reporting responsibilities from study start to December 2020. Upon acquisition, Smith+Nephew's Adverse Event Monitoring Board (AEMB) reviewed \& classified all adverse events from January 2021 to study termination, following ISO 14155 guidelines.
|
|
Musculoskeletal and connective tissue disorders
Connective Tissue Disease
|
3.3%
2/61 • Adverse events were collected upon implantation of the study device to early study termination, up to 5 years.
Ascension Orthopedics Inc. conducted monitoring \& reporting responsibilities from study start to December 2020. Upon acquisition, Smith+Nephew's Adverse Event Monitoring Board (AEMB) reviewed \& classified all adverse events from January 2021 to study termination, following ISO 14155 guidelines.
|
|
Musculoskeletal and connective tissue disorders
Joint Impingement
|
4.9%
3/61 • Adverse events were collected upon implantation of the study device to early study termination, up to 5 years.
Ascension Orthopedics Inc. conducted monitoring \& reporting responsibilities from study start to December 2020. Upon acquisition, Smith+Nephew's Adverse Event Monitoring Board (AEMB) reviewed \& classified all adverse events from January 2021 to study termination, following ISO 14155 guidelines.
|
|
Musculoskeletal and connective tissue disorders
Synovitis
|
1.6%
1/61 • Adverse events were collected upon implantation of the study device to early study termination, up to 5 years.
Ascension Orthopedics Inc. conducted monitoring \& reporting responsibilities from study start to December 2020. Upon acquisition, Smith+Nephew's Adverse Event Monitoring Board (AEMB) reviewed \& classified all adverse events from January 2021 to study termination, following ISO 14155 guidelines.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer
|
1.6%
1/61 • Adverse events were collected upon implantation of the study device to early study termination, up to 5 years.
Ascension Orthopedics Inc. conducted monitoring \& reporting responsibilities from study start to December 2020. Upon acquisition, Smith+Nephew's Adverse Event Monitoring Board (AEMB) reviewed \& classified all adverse events from January 2021 to study termination, following ISO 14155 guidelines.
|
Other adverse events
| Measure |
Integra® Cadence™ Total Ankle System
n=61 participants at risk
Participants undergoing primary ankle arthroplasty with the Integra® Cadence™ Total Ankle System (CTAS)
|
|---|---|
|
General disorders
Pain
|
3.3%
2/61 • Adverse events were collected upon implantation of the study device to early study termination, up to 5 years.
Ascension Orthopedics Inc. conducted monitoring \& reporting responsibilities from study start to December 2020. Upon acquisition, Smith+Nephew's Adverse Event Monitoring Board (AEMB) reviewed \& classified all adverse events from January 2021 to study termination, following ISO 14155 guidelines.
|
|
Immune system disorders
Hypersensitivity/Allergic reaction
|
3.3%
2/61 • Adverse events were collected upon implantation of the study device to early study termination, up to 5 years.
Ascension Orthopedics Inc. conducted monitoring \& reporting responsibilities from study start to December 2020. Upon acquisition, Smith+Nephew's Adverse Event Monitoring Board (AEMB) reviewed \& classified all adverse events from January 2021 to study termination, following ISO 14155 guidelines.
|
|
Musculoskeletal and connective tissue disorders
Limb Fracture
|
1.6%
1/61 • Adverse events were collected upon implantation of the study device to early study termination, up to 5 years.
Ascension Orthopedics Inc. conducted monitoring \& reporting responsibilities from study start to December 2020. Upon acquisition, Smith+Nephew's Adverse Event Monitoring Board (AEMB) reviewed \& classified all adverse events from January 2021 to study termination, following ISO 14155 guidelines.
|
|
Musculoskeletal and connective tissue disorders
Connective Tissue Disease
|
1.6%
1/61 • Adverse events were collected upon implantation of the study device to early study termination, up to 5 years.
Ascension Orthopedics Inc. conducted monitoring \& reporting responsibilities from study start to December 2020. Upon acquisition, Smith+Nephew's Adverse Event Monitoring Board (AEMB) reviewed \& classified all adverse events from January 2021 to study termination, following ISO 14155 guidelines.
|
|
Musculoskeletal and connective tissue disorders
Inadequate Osseointegration
|
1.6%
1/61 • Adverse events were collected upon implantation of the study device to early study termination, up to 5 years.
Ascension Orthopedics Inc. conducted monitoring \& reporting responsibilities from study start to December 2020. Upon acquisition, Smith+Nephew's Adverse Event Monitoring Board (AEMB) reviewed \& classified all adverse events from January 2021 to study termination, following ISO 14155 guidelines.
|
|
Musculoskeletal and connective tissue disorders
Joint Impingement
|
3.3%
2/61 • Adverse events were collected upon implantation of the study device to early study termination, up to 5 years.
Ascension Orthopedics Inc. conducted monitoring \& reporting responsibilities from study start to December 2020. Upon acquisition, Smith+Nephew's Adverse Event Monitoring Board (AEMB) reviewed \& classified all adverse events from January 2021 to study termination, following ISO 14155 guidelines.
|
|
Musculoskeletal and connective tissue disorders
Osteolysis
|
1.6%
1/61 • Adverse events were collected upon implantation of the study device to early study termination, up to 5 years.
Ascension Orthopedics Inc. conducted monitoring \& reporting responsibilities from study start to December 2020. Upon acquisition, Smith+Nephew's Adverse Event Monitoring Board (AEMB) reviewed \& classified all adverse events from January 2021 to study termination, following ISO 14155 guidelines.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cyst(s)
|
1.6%
1/61 • Adverse events were collected upon implantation of the study device to early study termination, up to 5 years.
Ascension Orthopedics Inc. conducted monitoring \& reporting responsibilities from study start to December 2020. Upon acquisition, Smith+Nephew's Adverse Event Monitoring Board (AEMB) reviewed \& classified all adverse events from January 2021 to study termination, following ISO 14155 guidelines.
|
|
Nervous system disorders
Cognitive Changes
|
1.6%
1/61 • Adverse events were collected upon implantation of the study device to early study termination, up to 5 years.
Ascension Orthopedics Inc. conducted monitoring \& reporting responsibilities from study start to December 2020. Upon acquisition, Smith+Nephew's Adverse Event Monitoring Board (AEMB) reviewed \& classified all adverse events from January 2021 to study termination, following ISO 14155 guidelines.
|
|
Injury, poisoning and procedural complications
Implant Pain
|
1.6%
1/61 • Adverse events were collected upon implantation of the study device to early study termination, up to 5 years.
Ascension Orthopedics Inc. conducted monitoring \& reporting responsibilities from study start to December 2020. Upon acquisition, Smith+Nephew's Adverse Event Monitoring Board (AEMB) reviewed \& classified all adverse events from January 2021 to study termination, following ISO 14155 guidelines.
|
|
Skin and subcutaneous tissue disorders
Impaired Healing
|
1.6%
1/61 • Adverse events were collected upon implantation of the study device to early study termination, up to 5 years.
Ascension Orthopedics Inc. conducted monitoring \& reporting responsibilities from study start to December 2020. Upon acquisition, Smith+Nephew's Adverse Event Monitoring Board (AEMB) reviewed \& classified all adverse events from January 2021 to study termination, following ISO 14155 guidelines.
|
Additional Information
Senior Manager Clinical Compliance
Smith+Nephew, Inc
Results disclosure agreements
- Principal investigator is a sponsor employee The sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period up to 60 days but less than or equal to 180 days from the time submitted to the sponsor for review. Sponsor may delay publication up to 180 days to permit the filing of appropriate patent applications if the sponsor believes any publication contains any information relating to patentable items and cannot extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER