Trial Outcomes & Findings for A Longitudinal Outcomes Study of the Subchondroplasty® Procedure in the Foot/Ankle (NCT NCT03087396)
NCT ID: NCT03087396
Last Updated: 2026-04-09
Results Overview
Foot Function Index - Revised Short Form (FFI-R SF) subscale scores. Measures foot pain, disability, and activity limitation. Items scored 1-4 (1=best, 4=worst); 5=not applicable to the subject and does not indicate worse function. Subscales calculated from applicable items and converted to 0-100%. Higher=more pain/worse function.
Recruitment status
COMPLETED
Target enrollment
148 participants
Primary outcome timeframe
24 months
Results posted on
2026-04-09
Participant Flow
Participant milestones
| Measure |
Subchondroplasty With AccuFill®
Subjects with at least one bone marrow lesion (BML) of any of the bones of the foot and/or ankle, who have elected to undergo or who have undergone the Subchondroplasty procedure using AccuFill® bone substitute material.
|
|---|---|
|
Overall Study
STARTED
|
148
|
|
Overall Study
COMPLETED
|
88
|
|
Overall Study
NOT COMPLETED
|
60
|
Reasons for withdrawal
| Measure |
Subchondroplasty With AccuFill®
Subjects with at least one bone marrow lesion (BML) of any of the bones of the foot and/or ankle, who have elected to undergo or who have undergone the Subchondroplasty procedure using AccuFill® bone substitute material.
|
|---|---|
|
Overall Study
Surgical Revision
|
12
|
|
Overall Study
Death
|
1
|
|
Overall Study
Physician Decision
|
3
|
|
Overall Study
Withdrawal by Subject
|
5
|
|
Overall Study
Lost to Follow-up
|
39
|
Baseline Characteristics
Of 148 enrolled participants, 134 were analyzed for most measures. For the activity limitation domain, N=133 due to missing data for one participant. Fourteen participants were not analyzed overall because data were unavailable or they discontinued early; specific reasons were not documented.
Baseline characteristics by cohort
| Measure |
Subchondroplasty With AccuFill®
n=148 Participants
Subjects with at least one bone marrow lesion (BML) of any of the bones of the foot and/or ankle, who have elected to undergo or who have undergone the Subchondroplasty procedure using AccuFill® bone substitute material.
|
|---|---|
|
Age, Continuous
|
45.27 years
STANDARD_DEVIATION 12.61 • n=148 Participants
|
|
Sex: Female, Male
Female
|
85 Participants
n=148 Participants
|
|
Sex: Female, Male
Male
|
63 Participants
n=148 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
20 Participants
n=148 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
120 Participants
n=148 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=148 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
4 Participants
n=148 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or other Pacific Islander
|
1 Participants
n=148 Participants
|
|
Race/Ethnicity, Customized
White
|
125 Participants
n=148 Participants
|
|
Race/Ethnicity, Customized
Other
|
5 Participants
n=148 Participants
|
|
Race/Ethnicity, Customized
Decline to Respond
|
5 Participants
n=148 Participants
|
|
Race/Ethnicity, Customized
Asian
|
5 Participants
n=148 Participants
|
|
Race/Ethnicity, Customized
Unknown or Not Reported
|
3 Participants
n=148 Participants
|
|
Region of Enrollment
Canada
|
7 participants
n=148 Participants
|
|
Region of Enrollment
United States
|
141 participants
n=148 Participants
|
|
Pain and functional performance at baseline by the Foot Function Index
Pain
|
65.7 Percentage scale
STANDARD_DEVIATION 18.2 • n=134 Participants • Of 148 enrolled participants, 134 were analyzed for most measures. For the activity limitation domain, N=133 due to missing data for one participant. Fourteen participants were not analyzed overall because data were unavailable or they discontinued early; specific reasons were not documented.
|
|
Pain and functional performance at baseline by the Foot Function Index
Stiffness
|
61.0 Percentage scale
STANDARD_DEVIATION 21.4 • n=134 Participants • Of 148 enrolled participants, 134 were analyzed for most measures. For the activity limitation domain, N=133 due to missing data for one participant. Fourteen participants were not analyzed overall because data were unavailable or they discontinued early; specific reasons were not documented.
|
|
Pain and functional performance at baseline by the Foot Function Index
Difficulty
|
69.9 Percentage scale
STANDARD_DEVIATION 17.9 • n=134 Participants • Of 148 enrolled participants, 134 were analyzed for most measures. For the activity limitation domain, N=133 due to missing data for one participant. Fourteen participants were not analyzed overall because data were unavailable or they discontinued early; specific reasons were not documented.
|
|
Pain and functional performance at baseline by the Foot Function Index
Activity Limitation
|
65.4 Percentage scale
STANDARD_DEVIATION 20.2 • n=133 Participants • Of 148 enrolled participants, 134 were analyzed for most measures. For the activity limitation domain, N=133 due to missing data for one participant. Fourteen participants were not analyzed overall because data were unavailable or they discontinued early; specific reasons were not documented.
|
|
Pain and functional performance at baseline by the Foot Function Index
Social Issues
|
50.9 Percentage scale
STANDARD_DEVIATION 20.6 • n=134 Participants • Of 148 enrolled participants, 134 were analyzed for most measures. For the activity limitation domain, N=133 due to missing data for one participant. Fourteen participants were not analyzed overall because data were unavailable or they discontinued early; specific reasons were not documented.
|
|
Pain and functional performance at baseline by the Numeric Pain Scale (NPS)
|
5.2 Points on a scale (0-10)
STANDARD_DEVIATION 2.3 • n=148 Participants
|
|
Foot Function Index at Baseline
|
62.5 Percentage scale
STANDARD_DEVIATION 16.6 • n=134 Participants • Of 148 enrolled participants, 134 were analyzed. Fourteen participants were not analyzed overall because data were unavailable or they discontinued early; specific reasons were not documented.
|
|
Subject quality-of-life at baseline by the EQ-5D-5L
|
0.5 Index score (0-1)
STANDARD_DEVIATION .3 • n=148 Participants
|
PRIMARY outcome
Timeframe: 24 monthsPopulation: All participants were analyzed together for outcomes, with subgroup analyses for on-label (mixed with blood or saline per IFU) and off-label (mixed with platelet-rich plasma or bone marrow aspirate concentrate) treatments. Off-label subjects were included for exploratory comparison. At 24 months, N=98 reflects participants with available outcome data at that visit.
Foot Function Index - Revised Short Form (FFI-R SF) subscale scores. Measures foot pain, disability, and activity limitation. Items scored 1-4 (1=best, 4=worst); 5=not applicable to the subject and does not indicate worse function. Subscales calculated from applicable items and converted to 0-100%. Higher=more pain/worse function.
Outcome measures
| Measure |
Subchondroplasty With AccuFill®
n=98 Participants
Subjects with at least one bone marrow lesion (BML) of any of the bones of the foot and/or ankle, who have elected to undergo or who have undergone the Subchondroplasty procedure using AccuFill® bone substitute material.
|
|---|---|
|
Foot Function Index-Revised (FFI-R) Short Form Score at 24 Months
All participants
|
42.8 Percentage scale
Standard Deviation 16.2
|
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Foot Function Index-Revised (FFI-R) Short Form Score at 24 Months
On-Label
|
43.0 Percentage scale
Standard Deviation 16.2
|
|
Foot Function Index-Revised (FFI-R) Short Form Score at 24 Months
Off-Label
|
39.6 Percentage scale
Standard Deviation 18.0
|
SECONDARY outcome
Timeframe: 6 weeks postoperativePopulation: All participants were analyzed together for outcomes, with subgroup analyses for on-label (mixed with blood or saline per IFU) and off-label (mixed with platelet-rich plasma or bone marrow aspirate concentrate) treatments. Off-label subjects were included for exploratory comparison. At 6 weeks, N=136 reflects participants with available outcome data at that visit.
Numeric Pain Score (NPS) reported on a 0-10 scale, where 0 = no pain and 10 = worst possible pain. Higher scores indicate greater pain intensity. Baseline values reflect pre-operative pain levels.
Outcome measures
| Measure |
Subchondroplasty With AccuFill®
n=136 Participants
Subjects with at least one bone marrow lesion (BML) of any of the bones of the foot and/or ankle, who have elected to undergo or who have undergone the Subchondroplasty procedure using AccuFill® bone substitute material.
|
|---|---|
|
Pain and Functional Performance by the Numeric Pain Score (NPS) From Baseline at 6-weeks
Off-label
|
3.3 Points on scale
Standard Deviation 1.6
|
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Pain and Functional Performance by the Numeric Pain Score (NPS) From Baseline at 6-weeks
All participants
|
3.4 Points on scale
Standard Deviation 2.1
|
|
Pain and Functional Performance by the Numeric Pain Score (NPS) From Baseline at 6-weeks
On-label
|
3.4 Points on scale
Standard Deviation 2.2
|
SECONDARY outcome
Timeframe: 6 weeks postoperativePopulation: All participants were analyzed together for outcomes, with subgroup analyses for on-label (mixed with blood or saline per IFU) and off-label (mixed with platelet-rich plasma or bone marrow aspirate concentrate) treatments. Off-label subjects were included for exploratory comparison. At 6 weeks, N=134 reflects participants with available outcome data at that visit.
Foot Function Index - Revised Short Form (FFI-R SF) subscale scores. Measures foot pain, disability, and activity limitation. Items scored 1-4 (1=best, 4=worst); 5=not applicable to the subject and does not indicate worse function. Subscales calculated from applicable items and converted to 0-100%. Higher=more pain/worse function.
Outcome measures
| Measure |
Subchondroplasty With AccuFill®
n=134 Participants
Subjects with at least one bone marrow lesion (BML) of any of the bones of the foot and/or ankle, who have elected to undergo or who have undergone the Subchondroplasty procedure using AccuFill® bone substitute material.
|
|---|---|
|
Pain and Functional Performance at 6 Weeks by the Foot Function Index-Revised (FFI-R) Short Form
All participants
|
59.2 Percentage scale
Standard Deviation 16.1
|
|
Pain and Functional Performance at 6 Weeks by the Foot Function Index-Revised (FFI-R) Short Form
On-Label
|
59.5 Percentage scale
Standard Deviation 16.0
|
|
Pain and Functional Performance at 6 Weeks by the Foot Function Index-Revised (FFI-R) Short Form
Off-Label
|
52.5 Percentage scale
Standard Deviation 18.4
|
SECONDARY outcome
Timeframe: 3 Months postoperativePopulation: All participants were analyzed together for outcomes, with subgroup analyses for on-label (mixed with blood or saline per IFU) and off-label (mixed with platelet-rich plasma or bone marrow aspirate concentrate) treatments. Off-label subjects were included for exploratory comparison. At 3 months, N=125 reflects participants with available outcome data at that visit.
Foot Function Index - Revised Short Form (FFI-R SF) subscale scores. Measures foot pain, disability, and activity limitation. Items scored 1-4 (1=best, 4=worst); 5=not applicable to the subject and does not indicate worse function. Subscales calculated from applicable items and converted to 0-100%. Higher=more pain/worse function.
Outcome measures
| Measure |
Subchondroplasty With AccuFill®
n=125 Participants
Subjects with at least one bone marrow lesion (BML) of any of the bones of the foot and/or ankle, who have elected to undergo or who have undergone the Subchondroplasty procedure using AccuFill® bone substitute material.
|
|---|---|
|
Pain and Functional Performance at 3 Months by the Foot Function Index-Revised (FFI-R) Short Form
All participants
|
51.5 Percentage scale
Standard Deviation 16.1
|
|
Pain and Functional Performance at 3 Months by the Foot Function Index-Revised (FFI-R) Short Form
On-Label
|
51.4 Percentage scale
Standard Deviation 16.1
|
|
Pain and Functional Performance at 3 Months by the Foot Function Index-Revised (FFI-R) Short Form
Off-Label
|
55.0 Percentage scale
Standard Deviation 15.5
|
SECONDARY outcome
Timeframe: 6 Months postoperativePopulation: All participants were analyzed together for outcomes, with subgroup analyses for on-label (mixed with blood or saline per IFU) and off-label (mixed with platelet-rich plasma or bone marrow aspirate concentrate) treatments. Off-label subjects were included for exploratory comparison. At 6 months, N=118 reflects participants with available outcome data at that visit.
Foot Function Index - Revised Short Form (FFI-R SF) subscale scores. Measures foot pain, disability, and activity limitation. Items scored 1-4 (1=best, 4=worst); 5=not applicable to the subject and does not indicate worse function. Subscales calculated from applicable items and converted to 0-100%. Higher=more pain/worse function.
Outcome measures
| Measure |
Subchondroplasty With AccuFill®
n=118 Participants
Subjects with at least one bone marrow lesion (BML) of any of the bones of the foot and/or ankle, who have elected to undergo or who have undergone the Subchondroplasty procedure using AccuFill® bone substitute material.
|
|---|---|
|
Pain and Functional Performance at 6 Months by the Foot Function Index-Revised (FFI-R) Short Form
All participants
|
48.1 Percentage scale
Standard Deviation 18.1
|
|
Pain and Functional Performance at 6 Months by the Foot Function Index-Revised (FFI-R) Short Form
On-Label
|
48.2 Percentage scale
Standard Deviation 18.0
|
|
Pain and Functional Performance at 6 Months by the Foot Function Index-Revised (FFI-R) Short Form
Off-Label
|
46.4 Percentage scale
Standard Deviation 21.8
|
SECONDARY outcome
Timeframe: 1 Year postoperativePopulation: All participants were analyzed together for outcomes, with subgroup analyses for on-label (mixed with blood or saline per IFU) and off-label (mixed with platelet-rich plasma or bone marrow aspirate concentrate) treatments. Off-label subjects were included for exploratory comparison. At 1 year, N=114 reflects participants with available outcome data at that visit.
Foot Function Index - Revised Short Form (FFI-R SF) subscale scores. Measures foot pain, disability, and activity limitation. Items scored 1-4 (1=best, 4=worst); 5=not applicable to the subject and does not indicate worse function. Subscales calculated from applicable items and converted to 0-100%. Higher=more pain/worse function.
Outcome measures
| Measure |
Subchondroplasty With AccuFill®
n=114 Participants
Subjects with at least one bone marrow lesion (BML) of any of the bones of the foot and/or ankle, who have elected to undergo or who have undergone the Subchondroplasty procedure using AccuFill® bone substitute material.
|
|---|---|
|
Pain and Functional Performance at 1 Year by the Foot Function Index-Revised (FFI-R) Short Form
All participants
|
45.7 Percentage scale
Standard Deviation 18.9
|
|
Pain and Functional Performance at 1 Year by the Foot Function Index-Revised (FFI-R) Short Form
On-Label
|
45.7 Percentage scale
Standard Deviation 18.7
|
|
Pain and Functional Performance at 1 Year by the Foot Function Index-Revised (FFI-R) Short Form
Off-Label
|
47.3 Percentage scale
Standard Deviation 26.8
|
SECONDARY outcome
Timeframe: 12 weeks postoperativePopulation: All participants were analyzed together for outcomes, with subgroup analyses for on-label (mixed with blood or saline per IFU) and off-label (mixed with platelet-rich plasma or bone marrow aspirate concentrate) treatments. Off-label subjects were included for exploratory comparison. At 12-weeks, N=136 reflects participants with available outcome data at that visit.
Numeric Pain Score (NPS) reported on a 0-10 scale, where 0 = no pain and 10 = worst possible pain. Higher scores indicate greater pain intensity. Baseline values reflect pre-operative pain levels.
Outcome measures
| Measure |
Subchondroplasty With AccuFill®
n=136 Participants
Subjects with at least one bone marrow lesion (BML) of any of the bones of the foot and/or ankle, who have elected to undergo or who have undergone the Subchondroplasty procedure using AccuFill® bone substitute material.
|
|---|---|
|
Pain and Functional Performance at 12-weeks by the Numeric Pain Score (NPS)
All participants
|
3.4 Points on scale
Standard Deviation 2.1
|
|
Pain and Functional Performance at 12-weeks by the Numeric Pain Score (NPS)
On-label
|
3.4 Points on scale
Standard Deviation 2.2
|
|
Pain and Functional Performance at 12-weeks by the Numeric Pain Score (NPS)
Off-label
|
3.3 Points on scale
Standard Deviation 1.6
|
SECONDARY outcome
Timeframe: 3 months postoperativePopulation: All participants were analyzed together for outcomes, with subgroup analyses for on-label (mixed with blood or saline per IFU) and off-label (mixed with platelet-rich plasma or bone marrow aspirate concentrate) treatments. Off-label subjects were included for exploratory comparison. At 3 months, N=125 reflects participants with available outcome data at that visit.
Numeric Pain Score (NPS) reported on a 0-10 scale, where 0 = no pain and 10 = worst possible pain. Higher scores indicate greater pain intensity. Baseline values reflect pre-operative pain levels.
Outcome measures
| Measure |
Subchondroplasty With AccuFill®
n=125 Participants
Subjects with at least one bone marrow lesion (BML) of any of the bones of the foot and/or ankle, who have elected to undergo or who have undergone the Subchondroplasty procedure using AccuFill® bone substitute material.
|
|---|---|
|
Pain and Functional Performance at 3-months by the Numeric Pain Score (NPS)
On-label
|
3.5 Points on scale
Standard Deviation 2.4
|
|
Pain and Functional Performance at 3-months by the Numeric Pain Score (NPS)
Off-label
|
4.8 Points on scale
Standard Deviation 2.2
|
|
Pain and Functional Performance at 3-months by the Numeric Pain Score (NPS)
All participants
|
3.5 Points on scale
Standard Deviation 2.4
|
SECONDARY outcome
Timeframe: 6 months postoperativePopulation: All participants were analyzed together for outcomes, with subgroup analyses for on-label (mixed with blood or saline per IFU) and off-label (mixed with platelet-rich plasma or bone marrow aspirate concentrate) treatments. Off-label subjects were included for exploratory comparison. At 6 months, N=118 reflects participants with available outcome data at that visit.
Numeric Pain Score (NPS) reported on a 0-10 scale, where 0 = no pain and 10 = worst possible pain. Higher scores indicate greater pain intensity. Baseline values reflect pre-operative pain levels.
Outcome measures
| Measure |
Subchondroplasty With AccuFill®
n=118 Participants
Subjects with at least one bone marrow lesion (BML) of any of the bones of the foot and/or ankle, who have elected to undergo or who have undergone the Subchondroplasty procedure using AccuFill® bone substitute material.
|
|---|---|
|
Pain and Functional Performance at 6-months by the Numeric Pain Score (NPS)
All participants
|
3.3 Points on scale
Standard Deviation 2.3
|
|
Pain and Functional Performance at 6-months by the Numeric Pain Score (NPS)
On-label
|
3.3 Points on scale
Standard Deviation 2.3
|
|
Pain and Functional Performance at 6-months by the Numeric Pain Score (NPS)
Off-label
|
3.2 Points on scale
Standard Deviation 2.6
|
SECONDARY outcome
Timeframe: 1 year postoperativePopulation: All participants were analyzed together for outcomes, with subgroup analyses for on-label (mixed with blood or saline per IFU) and off-label (mixed with platelet-rich plasma or bone marrow aspirate concentrate) treatments. Off-label subjects were included for exploratory comparison. At 1 year, N=113reflects participants with available outcome data at that visit.
Numeric Pain Score (NPS) reported on a 0-10 scale, where 0 = no pain and 10 = worst possible pain. Higher scores indicate greater pain intensity. Baseline values reflect pre-operative pain levels.
Outcome measures
| Measure |
Subchondroplasty With AccuFill®
n=113 Participants
Subjects with at least one bone marrow lesion (BML) of any of the bones of the foot and/or ankle, who have elected to undergo or who have undergone the Subchondroplasty procedure using AccuFill® bone substitute material.
|
|---|---|
|
Pain and Functional Performance at 1-year by the Numeric Pain Score (NPS)
All participants
|
3.2 Points on scale
Standard Deviation 2.7
|
|
Pain and Functional Performance at 1-year by the Numeric Pain Score (NPS)
On-label
|
3.2 Points on scale
Standard Deviation 2.7
|
|
Pain and Functional Performance at 1-year by the Numeric Pain Score (NPS)
Off-label
|
3.8 Points on scale
Standard Deviation 3.3
|
SECONDARY outcome
Timeframe: 2 years postoperativePopulation: All participants were analyzed together for outcomes, with subgroup analyses for on-label (mixed with blood or saline per IFU) and off-label (mixed with platelet-rich plasma or bone marrow aspirate concentrate) treatments. Off-label subjects were included for exploratory comparison. At 2 years, N=99 reflects participants with available outcome data at that visit.
Numeric Pain Score (NPS) reported on a 0-10 scale, where 0 = no pain and 10 = worst possible pain. Higher scores indicate greater pain intensity. Baseline values reflect pre-operative pain levels.
Outcome measures
| Measure |
Subchondroplasty With AccuFill®
n=99 Participants
Subjects with at least one bone marrow lesion (BML) of any of the bones of the foot and/or ankle, who have elected to undergo or who have undergone the Subchondroplasty procedure using AccuFill® bone substitute material.
|
|---|---|
|
Pain and Functional Performance at 2-years by the Numeric Pain Score (NPS)
All participants
|
2.9 Points on scale
Standard Deviation 2.4
|
|
Pain and Functional Performance at 2-years by the Numeric Pain Score (NPS)
On-label
|
2.9 Points on scale
Standard Deviation 2.4
|
|
Pain and Functional Performance at 2-years by the Numeric Pain Score (NPS)
Off-label
|
2.0 Points on scale
Standard Deviation 2.7
|
SECONDARY outcome
Timeframe: 6 weeks postoperativePopulation: All participants were analyzed together for outcomes, with subgroup analyses for on-label (mixed with blood or saline per IFU) and off-label (mixed with platelet-rich plasma or bone marrow aspirate concentrate) treatments. Off-label subjects were included for exploratory comparison. At 6-weeks, N=137 reflects participants with available outcome data at that visit.
Assesses health-related quality of life across five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression). Scores typically range from -0.594 to 1.000, where 1.000 indicates perfect health and lower scores indicate poorer health status.
Outcome measures
| Measure |
Subchondroplasty With AccuFill®
n=137 Participants
Subjects with at least one bone marrow lesion (BML) of any of the bones of the foot and/or ankle, who have elected to undergo or who have undergone the Subchondroplasty procedure using AccuFill® bone substitute material.
|
|---|---|
|
Subject Quality-of-life at 6-weeks by the EQ-5D
All participants
|
0.6 Index score
Standard Deviation 0.2
|
|
Subject Quality-of-life at 6-weeks by the EQ-5D
On-label
|
0.6 Index score
Standard Deviation 0.2
|
|
Subject Quality-of-life at 6-weeks by the EQ-5D
Off-label
|
0.7 Index score
Standard Deviation 0.1
|
SECONDARY outcome
Timeframe: 3 months postoperativePopulation: All participants were analyzed together for outcomes, with subgroup analyses for on-label (mixed with blood or saline per IFU) and off-label (mixed with platelet-rich plasma or bone marrow aspirate concentrate) treatments. Off-label subjects were included for exploratory comparison. At 3 months, N=126 reflects participants with available outcome data at that visit.
Assesses health-related quality of life across five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression). Scores typically range from -0.594 to 1.000, where 1.000 indicates perfect health and lower scores indicate poorer health status.
Outcome measures
| Measure |
Subchondroplasty With AccuFill®
n=126 Participants
Subjects with at least one bone marrow lesion (BML) of any of the bones of the foot and/or ankle, who have elected to undergo or who have undergone the Subchondroplasty procedure using AccuFill® bone substitute material.
|
|---|---|
|
Subject Quality-of-life at 3-months by the EQ-5D
All participants
|
0.7 Index score
Standard Deviation 0.2
|
|
Subject Quality-of-life at 3-months by the EQ-5D
On-label
|
0.7 Index score
Standard Deviation 0.2
|
|
Subject Quality-of-life at 3-months by the EQ-5D
Off-label
|
0.7 Index score
Standard Deviation 0.1
|
SECONDARY outcome
Timeframe: 6 months postoperativePopulation: All participants were analyzed together for outcomes, with subgroup analyses for on-label (mixed with blood or saline per IFU) and off-label (mixed with platelet-rich plasma or bone marrow aspirate concentrate) treatments. Off-label subjects were included for exploratory comparison. At 6 months, N=119 reflects participants with available outcome data at that visit.
Assesses health-related quality of life across five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression). Scores typically range from -0.594 to 1.000, where 1.000 indicates perfect health and lower scores indicate poorer health status.
Outcome measures
| Measure |
Subchondroplasty With AccuFill®
n=119 Participants
Subjects with at least one bone marrow lesion (BML) of any of the bones of the foot and/or ankle, who have elected to undergo or who have undergone the Subchondroplasty procedure using AccuFill® bone substitute material.
|
|---|---|
|
Subject Quality-of-life at 6-months by the EQ-5D
All participants
|
0.7 Index score
Standard Deviation 0.3
|
|
Subject Quality-of-life at 6-months by the EQ-5D
On-label
|
0.7 Index score
Standard Deviation 0.3
|
|
Subject Quality-of-life at 6-months by the EQ-5D
Off-label
|
0.6 Index score
Standard Deviation 0.3
|
SECONDARY outcome
Timeframe: 1 year postoperativePopulation: All participants were analyzed together for outcomes, with subgroup analyses for on-label (mixed with blood or saline per IFU) and off-label (mixed with platelet-rich plasma or bone marrow aspirate concentrate) treatments. Off-label subjects were included for exploratory comparison. At 1 year, N=114 reflects participants with available outcome data at that visit.
Assesses health-related quality of life across five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression). Scores typically range from -0.594 to 1.000, where 1.000 indicates perfect health and lower scores indicate poorer health status.
Outcome measures
| Measure |
Subchondroplasty With AccuFill®
n=114 Participants
Subjects with at least one bone marrow lesion (BML) of any of the bones of the foot and/or ankle, who have elected to undergo or who have undergone the Subchondroplasty procedure using AccuFill® bone substitute material.
|
|---|---|
|
Subject Quality-of-life at 1-year by the EQ-5D
All participants
|
0.7 Index score
Standard Deviation 0.3
|
|
Subject Quality-of-life at 1-year by the EQ-5D
On-label
|
0.7 Index score
Standard Deviation 0.3
|
|
Subject Quality-of-life at 1-year by the EQ-5D
Off-label
|
0.6 Index score
Standard Deviation 0.4
|
SECONDARY outcome
Timeframe: 2 year postoperativePopulation: All participants were analyzed together for outcomes, with subgroup analyses for on-label (mixed with blood or saline per IFU) and off-label (mixed with platelet-rich plasma or bone marrow aspirate concentrate) treatments. Off-label subjects were included for exploratory comparison. At 2 years, N=99 reflects participants with available outcome data at that visit.
Assesses health-related quality of life across five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression). Scores typically range from -0.594 to 1.000, where 1.000 indicates perfect health and lower scores indicate poorer health status.
Outcome measures
| Measure |
Subchondroplasty With AccuFill®
n=99 Participants
Subjects with at least one bone marrow lesion (BML) of any of the bones of the foot and/or ankle, who have elected to undergo or who have undergone the Subchondroplasty procedure using AccuFill® bone substitute material.
|
|---|---|
|
Subject Quality-of-life at 2-years by the EQ-5D
All participants
|
0.8 Index score
Standard Deviation 0.2
|
|
Subject Quality-of-life at 2-years by the EQ-5D
On-label
|
0.8 Index score
Standard Deviation 0.2
|
|
Subject Quality-of-life at 2-years by the EQ-5D
Off-label
|
0.9 Index score
Standard Deviation 0.1
|
Adverse Events
Subchondroplasty With AccuFill® (On-Label)
Serious events: 24 serious events
Other events: 44 other events
Deaths: 1 deaths
Subchondroplasty With AccuFill® (Off-Label)
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Subchondroplasty With AccuFill® (On-Label)
n=142 participants at risk
Subjects with at least one bone marrow lesion (BML) of any of the bones of the foot and/or ankle, who have elected to undergo or who have undergone the Subchondroplasty procedure using AccuFill® bone substitute material.
|
Subchondroplasty With AccuFill® (Off-Label)
n=6 participants at risk
Participants had ≥1 bone marrow lesion (BML) in the foot/ankle and underwent the Subchondroplasty® procedure using AccuFill® bone substitute material. Per the Instructions For Use (IFU), AccuFill® was intended to be mixed with blood or saline; however, some participants received off-label treatment where other materials (e.g., platelet rich plasma or bone marrow aspirate concentrate) were used.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Pain similar to pre-existing level with ambulation
|
0.70%
1/142 • Number of events 1 • Adverse event data were collected from the immediate postoperative period through the 6-week, 3-month, 6-month, 1 year, and 2-year follow-ups.
Adverse events (AEs) and serious adverse events (SAEs) were assessed during the immediate postoperative period and at scheduled follow-up visits (6 weeks, 3 months, 6 months, 1 year, and 2 years). Subjects were queried regarding any AEs, SAEs, and reoperations of the index foot/ankle. Any AE resulting in reoperation or revision was recorded as an SAE. All reoperations were documented using the Surgical Reoperation Form.
|
0.00%
0/6 • Adverse event data were collected from the immediate postoperative period through the 6-week, 3-month, 6-month, 1 year, and 2-year follow-ups.
Adverse events (AEs) and serious adverse events (SAEs) were assessed during the immediate postoperative period and at scheduled follow-up visits (6 weeks, 3 months, 6 months, 1 year, and 2 years). Subjects were queried regarding any AEs, SAEs, and reoperations of the index foot/ankle. Any AE resulting in reoperation or revision was recorded as an SAE. All reoperations were documented using the Surgical Reoperation Form.
|
|
Musculoskeletal and connective tissue disorders
Contracture of fifth toe, TTP and spasming of the extensor tendon
|
0.70%
1/142 • Number of events 1 • Adverse event data were collected from the immediate postoperative period through the 6-week, 3-month, 6-month, 1 year, and 2-year follow-ups.
Adverse events (AEs) and serious adverse events (SAEs) were assessed during the immediate postoperative period and at scheduled follow-up visits (6 weeks, 3 months, 6 months, 1 year, and 2 years). Subjects were queried regarding any AEs, SAEs, and reoperations of the index foot/ankle. Any AE resulting in reoperation or revision was recorded as an SAE. All reoperations were documented using the Surgical Reoperation Form.
|
0.00%
0/6 • Adverse event data were collected from the immediate postoperative period through the 6-week, 3-month, 6-month, 1 year, and 2-year follow-ups.
Adverse events (AEs) and serious adverse events (SAEs) were assessed during the immediate postoperative period and at scheduled follow-up visits (6 weeks, 3 months, 6 months, 1 year, and 2 years). Subjects were queried regarding any AEs, SAEs, and reoperations of the index foot/ankle. Any AE resulting in reoperation or revision was recorded as an SAE. All reoperations were documented using the Surgical Reoperation Form.
|
|
Musculoskeletal and connective tissue disorders
Degenerative disc
|
0.70%
1/142 • Number of events 1 • Adverse event data were collected from the immediate postoperative period through the 6-week, 3-month, 6-month, 1 year, and 2-year follow-ups.
Adverse events (AEs) and serious adverse events (SAEs) were assessed during the immediate postoperative period and at scheduled follow-up visits (6 weeks, 3 months, 6 months, 1 year, and 2 years). Subjects were queried regarding any AEs, SAEs, and reoperations of the index foot/ankle. Any AE resulting in reoperation or revision was recorded as an SAE. All reoperations were documented using the Surgical Reoperation Form.
|
0.00%
0/6 • Adverse event data were collected from the immediate postoperative period through the 6-week, 3-month, 6-month, 1 year, and 2-year follow-ups.
Adverse events (AEs) and serious adverse events (SAEs) were assessed during the immediate postoperative period and at scheduled follow-up visits (6 weeks, 3 months, 6 months, 1 year, and 2 years). Subjects were queried regarding any AEs, SAEs, and reoperations of the index foot/ankle. Any AE resulting in reoperation or revision was recorded as an SAE. All reoperations were documented using the Surgical Reoperation Form.
|
|
Skin and subcutaneous tissue disorders
Exacerbation of lymphedema of right leg
|
0.70%
1/142 • Number of events 1 • Adverse event data were collected from the immediate postoperative period through the 6-week, 3-month, 6-month, 1 year, and 2-year follow-ups.
Adverse events (AEs) and serious adverse events (SAEs) were assessed during the immediate postoperative period and at scheduled follow-up visits (6 weeks, 3 months, 6 months, 1 year, and 2 years). Subjects were queried regarding any AEs, SAEs, and reoperations of the index foot/ankle. Any AE resulting in reoperation or revision was recorded as an SAE. All reoperations were documented using the Surgical Reoperation Form.
|
0.00%
0/6 • Adverse event data were collected from the immediate postoperative period through the 6-week, 3-month, 6-month, 1 year, and 2-year follow-ups.
Adverse events (AEs) and serious adverse events (SAEs) were assessed during the immediate postoperative period and at scheduled follow-up visits (6 weeks, 3 months, 6 months, 1 year, and 2 years). Subjects were queried regarding any AEs, SAEs, and reoperations of the index foot/ankle. Any AE resulting in reoperation or revision was recorded as an SAE. All reoperations were documented using the Surgical Reoperation Form.
|
|
Reproductive system and breast disorders
Fibroid Uterus causing abnormal uterine bleeding
|
0.70%
1/142 • Number of events 1 • Adverse event data were collected from the immediate postoperative period through the 6-week, 3-month, 6-month, 1 year, and 2-year follow-ups.
Adverse events (AEs) and serious adverse events (SAEs) were assessed during the immediate postoperative period and at scheduled follow-up visits (6 weeks, 3 months, 6 months, 1 year, and 2 years). Subjects were queried regarding any AEs, SAEs, and reoperations of the index foot/ankle. Any AE resulting in reoperation or revision was recorded as an SAE. All reoperations were documented using the Surgical Reoperation Form.
|
0.00%
0/6 • Adverse event data were collected from the immediate postoperative period through the 6-week, 3-month, 6-month, 1 year, and 2-year follow-ups.
Adverse events (AEs) and serious adverse events (SAEs) were assessed during the immediate postoperative period and at scheduled follow-up visits (6 weeks, 3 months, 6 months, 1 year, and 2 years). Subjects were queried regarding any AEs, SAEs, and reoperations of the index foot/ankle. Any AE resulting in reoperation or revision was recorded as an SAE. All reoperations were documented using the Surgical Reoperation Form.
|
|
Musculoskeletal and connective tissue disorders
Fibrous coalition
|
0.70%
1/142 • Number of events 1 • Adverse event data were collected from the immediate postoperative period through the 6-week, 3-month, 6-month, 1 year, and 2-year follow-ups.
Adverse events (AEs) and serious adverse events (SAEs) were assessed during the immediate postoperative period and at scheduled follow-up visits (6 weeks, 3 months, 6 months, 1 year, and 2 years). Subjects were queried regarding any AEs, SAEs, and reoperations of the index foot/ankle. Any AE resulting in reoperation or revision was recorded as an SAE. All reoperations were documented using the Surgical Reoperation Form.
|
0.00%
0/6 • Adverse event data were collected from the immediate postoperative period through the 6-week, 3-month, 6-month, 1 year, and 2-year follow-ups.
Adverse events (AEs) and serious adverse events (SAEs) were assessed during the immediate postoperative period and at scheduled follow-up visits (6 weeks, 3 months, 6 months, 1 year, and 2 years). Subjects were queried regarding any AEs, SAEs, and reoperations of the index foot/ankle. Any AE resulting in reoperation or revision was recorded as an SAE. All reoperations were documented using the Surgical Reoperation Form.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glioblastoma
|
0.70%
1/142 • Number of events 1 • Adverse event data were collected from the immediate postoperative period through the 6-week, 3-month, 6-month, 1 year, and 2-year follow-ups.
Adverse events (AEs) and serious adverse events (SAEs) were assessed during the immediate postoperative period and at scheduled follow-up visits (6 weeks, 3 months, 6 months, 1 year, and 2 years). Subjects were queried regarding any AEs, SAEs, and reoperations of the index foot/ankle. Any AE resulting in reoperation or revision was recorded as an SAE. All reoperations were documented using the Surgical Reoperation Form.
|
0.00%
0/6 • Adverse event data were collected from the immediate postoperative period through the 6-week, 3-month, 6-month, 1 year, and 2-year follow-ups.
Adverse events (AEs) and serious adverse events (SAEs) were assessed during the immediate postoperative period and at scheduled follow-up visits (6 weeks, 3 months, 6 months, 1 year, and 2 years). Subjects were queried regarding any AEs, SAEs, and reoperations of the index foot/ankle. Any AE resulting in reoperation or revision was recorded as an SAE. All reoperations were documented using the Surgical Reoperation Form.
|
|
Musculoskeletal and connective tissue disorders
Intractable subacute left foot postoperative pain
|
0.70%
1/142 • Number of events 1 • Adverse event data were collected from the immediate postoperative period through the 6-week, 3-month, 6-month, 1 year, and 2-year follow-ups.
Adverse events (AEs) and serious adverse events (SAEs) were assessed during the immediate postoperative period and at scheduled follow-up visits (6 weeks, 3 months, 6 months, 1 year, and 2 years). Subjects were queried regarding any AEs, SAEs, and reoperations of the index foot/ankle. Any AE resulting in reoperation or revision was recorded as an SAE. All reoperations were documented using the Surgical Reoperation Form.
|
0.00%
0/6 • Adverse event data were collected from the immediate postoperative period through the 6-week, 3-month, 6-month, 1 year, and 2-year follow-ups.
Adverse events (AEs) and serious adverse events (SAEs) were assessed during the immediate postoperative period and at scheduled follow-up visits (6 weeks, 3 months, 6 months, 1 year, and 2 years). Subjects were queried regarding any AEs, SAEs, and reoperations of the index foot/ankle. Any AE resulting in reoperation or revision was recorded as an SAE. All reoperations were documented using the Surgical Reoperation Form.
|
|
Blood and lymphatic system disorders
Iron deficiency, anemia
|
0.70%
1/142 • Number of events 1 • Adverse event data were collected from the immediate postoperative period through the 6-week, 3-month, 6-month, 1 year, and 2-year follow-ups.
Adverse events (AEs) and serious adverse events (SAEs) were assessed during the immediate postoperative period and at scheduled follow-up visits (6 weeks, 3 months, 6 months, 1 year, and 2 years). Subjects were queried regarding any AEs, SAEs, and reoperations of the index foot/ankle. Any AE resulting in reoperation or revision was recorded as an SAE. All reoperations were documented using the Surgical Reoperation Form.
|
0.00%
0/6 • Adverse event data were collected from the immediate postoperative period through the 6-week, 3-month, 6-month, 1 year, and 2-year follow-ups.
Adverse events (AEs) and serious adverse events (SAEs) were assessed during the immediate postoperative period and at scheduled follow-up visits (6 weeks, 3 months, 6 months, 1 year, and 2 years). Subjects were queried regarding any AEs, SAEs, and reoperations of the index foot/ankle. Any AE resulting in reoperation or revision was recorded as an SAE. All reoperations were documented using the Surgical Reoperation Form.
|
|
Musculoskeletal and connective tissue disorders
Left ankle nerve pain
|
0.70%
1/142 • Number of events 1 • Adverse event data were collected from the immediate postoperative period through the 6-week, 3-month, 6-month, 1 year, and 2-year follow-ups.
Adverse events (AEs) and serious adverse events (SAEs) were assessed during the immediate postoperative period and at scheduled follow-up visits (6 weeks, 3 months, 6 months, 1 year, and 2 years). Subjects were queried regarding any AEs, SAEs, and reoperations of the index foot/ankle. Any AE resulting in reoperation or revision was recorded as an SAE. All reoperations were documented using the Surgical Reoperation Form.
|
0.00%
0/6 • Adverse event data were collected from the immediate postoperative period through the 6-week, 3-month, 6-month, 1 year, and 2-year follow-ups.
Adverse events (AEs) and serious adverse events (SAEs) were assessed during the immediate postoperative period and at scheduled follow-up visits (6 weeks, 3 months, 6 months, 1 year, and 2 years). Subjects were queried regarding any AEs, SAEs, and reoperations of the index foot/ankle. Any AE resulting in reoperation or revision was recorded as an SAE. All reoperations were documented using the Surgical Reoperation Form.
|
|
Musculoskeletal and connective tissue disorders
Left foot and ankle pain
|
0.70%
1/142 • Number of events 1 • Adverse event data were collected from the immediate postoperative period through the 6-week, 3-month, 6-month, 1 year, and 2-year follow-ups.
Adverse events (AEs) and serious adverse events (SAEs) were assessed during the immediate postoperative period and at scheduled follow-up visits (6 weeks, 3 months, 6 months, 1 year, and 2 years). Subjects were queried regarding any AEs, SAEs, and reoperations of the index foot/ankle. Any AE resulting in reoperation or revision was recorded as an SAE. All reoperations were documented using the Surgical Reoperation Form.
|
0.00%
0/6 • Adverse event data were collected from the immediate postoperative period through the 6-week, 3-month, 6-month, 1 year, and 2-year follow-ups.
Adverse events (AEs) and serious adverse events (SAEs) were assessed during the immediate postoperative period and at scheduled follow-up visits (6 weeks, 3 months, 6 months, 1 year, and 2 years). Subjects were queried regarding any AEs, SAEs, and reoperations of the index foot/ankle. Any AE resulting in reoperation or revision was recorded as an SAE. All reoperations were documented using the Surgical Reoperation Form.
|
|
Injury, poisoning and procedural complications
Left talus bony edema
|
0.70%
1/142 • Number of events 1 • Adverse event data were collected from the immediate postoperative period through the 6-week, 3-month, 6-month, 1 year, and 2-year follow-ups.
Adverse events (AEs) and serious adverse events (SAEs) were assessed during the immediate postoperative period and at scheduled follow-up visits (6 weeks, 3 months, 6 months, 1 year, and 2 years). Subjects were queried regarding any AEs, SAEs, and reoperations of the index foot/ankle. Any AE resulting in reoperation or revision was recorded as an SAE. All reoperations were documented using the Surgical Reoperation Form.
|
0.00%
0/6 • Adverse event data were collected from the immediate postoperative period through the 6-week, 3-month, 6-month, 1 year, and 2-year follow-ups.
Adverse events (AEs) and serious adverse events (SAEs) were assessed during the immediate postoperative period and at scheduled follow-up visits (6 weeks, 3 months, 6 months, 1 year, and 2 years). Subjects were queried regarding any AEs, SAEs, and reoperations of the index foot/ankle. Any AE resulting in reoperation or revision was recorded as an SAE. All reoperations were documented using the Surgical Reoperation Form.
|
|
Musculoskeletal and connective tissue disorders
Medial foot pain (Left)
|
0.70%
1/142 • Number of events 1 • Adverse event data were collected from the immediate postoperative period through the 6-week, 3-month, 6-month, 1 year, and 2-year follow-ups.
Adverse events (AEs) and serious adverse events (SAEs) were assessed during the immediate postoperative period and at scheduled follow-up visits (6 weeks, 3 months, 6 months, 1 year, and 2 years). Subjects were queried regarding any AEs, SAEs, and reoperations of the index foot/ankle. Any AE resulting in reoperation or revision was recorded as an SAE. All reoperations were documented using the Surgical Reoperation Form.
|
0.00%
0/6 • Adverse event data were collected from the immediate postoperative period through the 6-week, 3-month, 6-month, 1 year, and 2-year follow-ups.
Adverse events (AEs) and serious adverse events (SAEs) were assessed during the immediate postoperative period and at scheduled follow-up visits (6 weeks, 3 months, 6 months, 1 year, and 2 years). Subjects were queried regarding any AEs, SAEs, and reoperations of the index foot/ankle. Any AE resulting in reoperation or revision was recorded as an SAE. All reoperations were documented using the Surgical Reoperation Form.
|
|
Musculoskeletal and connective tissue disorders
Morton's neuroma
|
0.70%
1/142 • Number of events 1 • Adverse event data were collected from the immediate postoperative period through the 6-week, 3-month, 6-month, 1 year, and 2-year follow-ups.
Adverse events (AEs) and serious adverse events (SAEs) were assessed during the immediate postoperative period and at scheduled follow-up visits (6 weeks, 3 months, 6 months, 1 year, and 2 years). Subjects were queried regarding any AEs, SAEs, and reoperations of the index foot/ankle. Any AE resulting in reoperation or revision was recorded as an SAE. All reoperations were documented using the Surgical Reoperation Form.
|
0.00%
0/6 • Adverse event data were collected from the immediate postoperative period through the 6-week, 3-month, 6-month, 1 year, and 2-year follow-ups.
Adverse events (AEs) and serious adverse events (SAEs) were assessed during the immediate postoperative period and at scheduled follow-up visits (6 weeks, 3 months, 6 months, 1 year, and 2 years). Subjects were queried regarding any AEs, SAEs, and reoperations of the index foot/ankle. Any AE resulting in reoperation or revision was recorded as an SAE. All reoperations were documented using the Surgical Reoperation Form.
|
|
Musculoskeletal and connective tissue disorders
Numbness left lateral hindfoot
|
0.70%
1/142 • Number of events 1 • Adverse event data were collected from the immediate postoperative period through the 6-week, 3-month, 6-month, 1 year, and 2-year follow-ups.
Adverse events (AEs) and serious adverse events (SAEs) were assessed during the immediate postoperative period and at scheduled follow-up visits (6 weeks, 3 months, 6 months, 1 year, and 2 years). Subjects were queried regarding any AEs, SAEs, and reoperations of the index foot/ankle. Any AE resulting in reoperation or revision was recorded as an SAE. All reoperations were documented using the Surgical Reoperation Form.
|
0.00%
0/6 • Adverse event data were collected from the immediate postoperative period through the 6-week, 3-month, 6-month, 1 year, and 2-year follow-ups.
Adverse events (AEs) and serious adverse events (SAEs) were assessed during the immediate postoperative period and at scheduled follow-up visits (6 weeks, 3 months, 6 months, 1 year, and 2 years). Subjects were queried regarding any AEs, SAEs, and reoperations of the index foot/ankle. Any AE resulting in reoperation or revision was recorded as an SAE. All reoperations were documented using the Surgical Reoperation Form.
|
|
Musculoskeletal and connective tissue disorders
Ongoing pain from multiple pre-existing injuries
|
0.70%
1/142 • Number of events 2 • Adverse event data were collected from the immediate postoperative period through the 6-week, 3-month, 6-month, 1 year, and 2-year follow-ups.
Adverse events (AEs) and serious adverse events (SAEs) were assessed during the immediate postoperative period and at scheduled follow-up visits (6 weeks, 3 months, 6 months, 1 year, and 2 years). Subjects were queried regarding any AEs, SAEs, and reoperations of the index foot/ankle. Any AE resulting in reoperation or revision was recorded as an SAE. All reoperations were documented using the Surgical Reoperation Form.
|
0.00%
0/6 • Adverse event data were collected from the immediate postoperative period through the 6-week, 3-month, 6-month, 1 year, and 2-year follow-ups.
Adverse events (AEs) and serious adverse events (SAEs) were assessed during the immediate postoperative period and at scheduled follow-up visits (6 weeks, 3 months, 6 months, 1 year, and 2 years). Subjects were queried regarding any AEs, SAEs, and reoperations of the index foot/ankle. Any AE resulting in reoperation or revision was recorded as an SAE. All reoperations were documented using the Surgical Reoperation Form.
|
|
Cardiac disorders
Chest pain radiating to left arm
|
0.70%
1/142 • Number of events 1 • Adverse event data were collected from the immediate postoperative period through the 6-week, 3-month, 6-month, 1 year, and 2-year follow-ups.
Adverse events (AEs) and serious adverse events (SAEs) were assessed during the immediate postoperative period and at scheduled follow-up visits (6 weeks, 3 months, 6 months, 1 year, and 2 years). Subjects were queried regarding any AEs, SAEs, and reoperations of the index foot/ankle. Any AE resulting in reoperation or revision was recorded as an SAE. All reoperations were documented using the Surgical Reoperation Form.
|
0.00%
0/6 • Adverse event data were collected from the immediate postoperative period through the 6-week, 3-month, 6-month, 1 year, and 2-year follow-ups.
Adverse events (AEs) and serious adverse events (SAEs) were assessed during the immediate postoperative period and at scheduled follow-up visits (6 weeks, 3 months, 6 months, 1 year, and 2 years). Subjects were queried regarding any AEs, SAEs, and reoperations of the index foot/ankle. Any AE resulting in reoperation or revision was recorded as an SAE. All reoperations were documented using the Surgical Reoperation Form.
|
|
Musculoskeletal and connective tissue disorders
Chronic left ankle stability (reported term)
|
0.70%
1/142 • Number of events 1 • Adverse event data were collected from the immediate postoperative period through the 6-week, 3-month, 6-month, 1 year, and 2-year follow-ups.
Adverse events (AEs) and serious adverse events (SAEs) were assessed during the immediate postoperative period and at scheduled follow-up visits (6 weeks, 3 months, 6 months, 1 year, and 2 years). Subjects were queried regarding any AEs, SAEs, and reoperations of the index foot/ankle. Any AE resulting in reoperation or revision was recorded as an SAE. All reoperations were documented using the Surgical Reoperation Form.
|
0.00%
0/6 • Adverse event data were collected from the immediate postoperative period through the 6-week, 3-month, 6-month, 1 year, and 2-year follow-ups.
Adverse events (AEs) and serious adverse events (SAEs) were assessed during the immediate postoperative period and at scheduled follow-up visits (6 weeks, 3 months, 6 months, 1 year, and 2 years). Subjects were queried regarding any AEs, SAEs, and reoperations of the index foot/ankle. Any AE resulting in reoperation or revision was recorded as an SAE. All reoperations were documented using the Surgical Reoperation Form.
|
|
Reproductive system and breast disorders
Postmenopausal bleeding
|
0.70%
1/142 • Number of events 1 • Adverse event data were collected from the immediate postoperative period through the 6-week, 3-month, 6-month, 1 year, and 2-year follow-ups.
Adverse events (AEs) and serious adverse events (SAEs) were assessed during the immediate postoperative period and at scheduled follow-up visits (6 weeks, 3 months, 6 months, 1 year, and 2 years). Subjects were queried regarding any AEs, SAEs, and reoperations of the index foot/ankle. Any AE resulting in reoperation or revision was recorded as an SAE. All reoperations were documented using the Surgical Reoperation Form.
|
0.00%
0/6 • Adverse event data were collected from the immediate postoperative period through the 6-week, 3-month, 6-month, 1 year, and 2-year follow-ups.
Adverse events (AEs) and serious adverse events (SAEs) were assessed during the immediate postoperative period and at scheduled follow-up visits (6 weeks, 3 months, 6 months, 1 year, and 2 years). Subjects were queried regarding any AEs, SAEs, and reoperations of the index foot/ankle. Any AE resulting in reoperation or revision was recorded as an SAE. All reoperations were documented using the Surgical Reoperation Form.
|
|
Musculoskeletal and connective tissue disorders
Continued osteoarthritis
|
0.70%
1/142 • Number of events 1 • Adverse event data were collected from the immediate postoperative period through the 6-week, 3-month, 6-month, 1 year, and 2-year follow-ups.
Adverse events (AEs) and serious adverse events (SAEs) were assessed during the immediate postoperative period and at scheduled follow-up visits (6 weeks, 3 months, 6 months, 1 year, and 2 years). Subjects were queried regarding any AEs, SAEs, and reoperations of the index foot/ankle. Any AE resulting in reoperation or revision was recorded as an SAE. All reoperations were documented using the Surgical Reoperation Form.
|
0.00%
0/6 • Adverse event data were collected from the immediate postoperative period through the 6-week, 3-month, 6-month, 1 year, and 2-year follow-ups.
Adverse events (AEs) and serious adverse events (SAEs) were assessed during the immediate postoperative period and at scheduled follow-up visits (6 weeks, 3 months, 6 months, 1 year, and 2 years). Subjects were queried regarding any AEs, SAEs, and reoperations of the index foot/ankle. Any AE resulting in reoperation or revision was recorded as an SAE. All reoperations were documented using the Surgical Reoperation Form.
|
|
Musculoskeletal and connective tissue disorders
Plantar fasciitis and Achilles tendon pain
|
0.70%
1/142 • Number of events 1 • Adverse event data were collected from the immediate postoperative period through the 6-week, 3-month, 6-month, 1 year, and 2-year follow-ups.
Adverse events (AEs) and serious adverse events (SAEs) were assessed during the immediate postoperative period and at scheduled follow-up visits (6 weeks, 3 months, 6 months, 1 year, and 2 years). Subjects were queried regarding any AEs, SAEs, and reoperations of the index foot/ankle. Any AE resulting in reoperation or revision was recorded as an SAE. All reoperations were documented using the Surgical Reoperation Form.
|
0.00%
0/6 • Adverse event data were collected from the immediate postoperative period through the 6-week, 3-month, 6-month, 1 year, and 2-year follow-ups.
Adverse events (AEs) and serious adverse events (SAEs) were assessed during the immediate postoperative period and at scheduled follow-up visits (6 weeks, 3 months, 6 months, 1 year, and 2 years). Subjects were queried regarding any AEs, SAEs, and reoperations of the index foot/ankle. Any AE resulting in reoperation or revision was recorded as an SAE. All reoperations were documented using the Surgical Reoperation Form.
|
|
Musculoskeletal and connective tissue disorders
Right Ankle Instability and 2nd Hammertoe
|
0.70%
1/142 • Number of events 1 • Adverse event data were collected from the immediate postoperative period through the 6-week, 3-month, 6-month, 1 year, and 2-year follow-ups.
Adverse events (AEs) and serious adverse events (SAEs) were assessed during the immediate postoperative period and at scheduled follow-up visits (6 weeks, 3 months, 6 months, 1 year, and 2 years). Subjects were queried regarding any AEs, SAEs, and reoperations of the index foot/ankle. Any AE resulting in reoperation or revision was recorded as an SAE. All reoperations were documented using the Surgical Reoperation Form.
|
0.00%
0/6 • Adverse event data were collected from the immediate postoperative period through the 6-week, 3-month, 6-month, 1 year, and 2-year follow-ups.
Adverse events (AEs) and serious adverse events (SAEs) were assessed during the immediate postoperative period and at scheduled follow-up visits (6 weeks, 3 months, 6 months, 1 year, and 2 years). Subjects were queried regarding any AEs, SAEs, and reoperations of the index foot/ankle. Any AE resulting in reoperation or revision was recorded as an SAE. All reoperations were documented using the Surgical Reoperation Form.
|
|
Musculoskeletal and connective tissue disorders
Right ankle pain
|
1.4%
2/142 • Number of events 2 • Adverse event data were collected from the immediate postoperative period through the 6-week, 3-month, 6-month, 1 year, and 2-year follow-ups.
Adverse events (AEs) and serious adverse events (SAEs) were assessed during the immediate postoperative period and at scheduled follow-up visits (6 weeks, 3 months, 6 months, 1 year, and 2 years). Subjects were queried regarding any AEs, SAEs, and reoperations of the index foot/ankle. Any AE resulting in reoperation or revision was recorded as an SAE. All reoperations were documented using the Surgical Reoperation Form.
|
0.00%
0/6 • Adverse event data were collected from the immediate postoperative period through the 6-week, 3-month, 6-month, 1 year, and 2-year follow-ups.
Adverse events (AEs) and serious adverse events (SAEs) were assessed during the immediate postoperative period and at scheduled follow-up visits (6 weeks, 3 months, 6 months, 1 year, and 2 years). Subjects were queried regarding any AEs, SAEs, and reoperations of the index foot/ankle. Any AE resulting in reoperation or revision was recorded as an SAE. All reoperations were documented using the Surgical Reoperation Form.
|
|
Musculoskeletal and connective tissue disorders
L 2nd/5th metatarsal fractures
|
0.70%
1/142 • Number of events 1 • Adverse event data were collected from the immediate postoperative period through the 6-week, 3-month, 6-month, 1 year, and 2-year follow-ups.
Adverse events (AEs) and serious adverse events (SAEs) were assessed during the immediate postoperative period and at scheduled follow-up visits (6 weeks, 3 months, 6 months, 1 year, and 2 years). Subjects were queried regarding any AEs, SAEs, and reoperations of the index foot/ankle. Any AE resulting in reoperation or revision was recorded as an SAE. All reoperations were documented using the Surgical Reoperation Form.
|
0.00%
0/6 • Adverse event data were collected from the immediate postoperative period through the 6-week, 3-month, 6-month, 1 year, and 2-year follow-ups.
Adverse events (AEs) and serious adverse events (SAEs) were assessed during the immediate postoperative period and at scheduled follow-up visits (6 weeks, 3 months, 6 months, 1 year, and 2 years). Subjects were queried regarding any AEs, SAEs, and reoperations of the index foot/ankle. Any AE resulting in reoperation or revision was recorded as an SAE. All reoperations were documented using the Surgical Reoperation Form.
|
|
Injury, poisoning and procedural complications
Stress Fracture (or Stress Response of Metatarsal)
|
0.00%
0/142 • Adverse event data were collected from the immediate postoperative period through the 6-week, 3-month, 6-month, 1 year, and 2-year follow-ups.
Adverse events (AEs) and serious adverse events (SAEs) were assessed during the immediate postoperative period and at scheduled follow-up visits (6 weeks, 3 months, 6 months, 1 year, and 2 years). Subjects were queried regarding any AEs, SAEs, and reoperations of the index foot/ankle. Any AE resulting in reoperation or revision was recorded as an SAE. All reoperations were documented using the Surgical Reoperation Form.
|
16.7%
1/6 • Number of events 1 • Adverse event data were collected from the immediate postoperative period through the 6-week, 3-month, 6-month, 1 year, and 2-year follow-ups.
Adverse events (AEs) and serious adverse events (SAEs) were assessed during the immediate postoperative period and at scheduled follow-up visits (6 weeks, 3 months, 6 months, 1 year, and 2 years). Subjects were queried regarding any AEs, SAEs, and reoperations of the index foot/ankle. Any AE resulting in reoperation or revision was recorded as an SAE. All reoperations were documented using the Surgical Reoperation Form.
|
|
Blood and lymphatic system disorders
Exacerbation of lymphedema of right leg
|
0.70%
1/142 • Number of events 1 • Adverse event data were collected from the immediate postoperative period through the 6-week, 3-month, 6-month, 1 year, and 2-year follow-ups.
Adverse events (AEs) and serious adverse events (SAEs) were assessed during the immediate postoperative period and at scheduled follow-up visits (6 weeks, 3 months, 6 months, 1 year, and 2 years). Subjects were queried regarding any AEs, SAEs, and reoperations of the index foot/ankle. Any AE resulting in reoperation or revision was recorded as an SAE. All reoperations were documented using the Surgical Reoperation Form.
|
0.00%
0/6 • Adverse event data were collected from the immediate postoperative period through the 6-week, 3-month, 6-month, 1 year, and 2-year follow-ups.
Adverse events (AEs) and serious adverse events (SAEs) were assessed during the immediate postoperative period and at scheduled follow-up visits (6 weeks, 3 months, 6 months, 1 year, and 2 years). Subjects were queried regarding any AEs, SAEs, and reoperations of the index foot/ankle. Any AE resulting in reoperation or revision was recorded as an SAE. All reoperations were documented using the Surgical Reoperation Form.
|
|
Musculoskeletal and connective tissue disorders
Severe postop pain
|
0.70%
1/142 • Number of events 1 • Adverse event data were collected from the immediate postoperative period through the 6-week, 3-month, 6-month, 1 year, and 2-year follow-ups.
Adverse events (AEs) and serious adverse events (SAEs) were assessed during the immediate postoperative period and at scheduled follow-up visits (6 weeks, 3 months, 6 months, 1 year, and 2 years). Subjects were queried regarding any AEs, SAEs, and reoperations of the index foot/ankle. Any AE resulting in reoperation or revision was recorded as an SAE. All reoperations were documented using the Surgical Reoperation Form.
|
0.00%
0/6 • Adverse event data were collected from the immediate postoperative period through the 6-week, 3-month, 6-month, 1 year, and 2-year follow-ups.
Adverse events (AEs) and serious adverse events (SAEs) were assessed during the immediate postoperative period and at scheduled follow-up visits (6 weeks, 3 months, 6 months, 1 year, and 2 years). Subjects were queried regarding any AEs, SAEs, and reoperations of the index foot/ankle. Any AE resulting in reoperation or revision was recorded as an SAE. All reoperations were documented using the Surgical Reoperation Form.
|
|
Musculoskeletal and connective tissue disorders
Increased right medial ankle/midfoot pain
|
0.70%
1/142 • Number of events 1 • Adverse event data were collected from the immediate postoperative period through the 6-week, 3-month, 6-month, 1 year, and 2-year follow-ups.
Adverse events (AEs) and serious adverse events (SAEs) were assessed during the immediate postoperative period and at scheduled follow-up visits (6 weeks, 3 months, 6 months, 1 year, and 2 years). Subjects were queried regarding any AEs, SAEs, and reoperations of the index foot/ankle. Any AE resulting in reoperation or revision was recorded as an SAE. All reoperations were documented using the Surgical Reoperation Form.
|
0.00%
0/6 • Adverse event data were collected from the immediate postoperative period through the 6-week, 3-month, 6-month, 1 year, and 2-year follow-ups.
Adverse events (AEs) and serious adverse events (SAEs) were assessed during the immediate postoperative period and at scheduled follow-up visits (6 weeks, 3 months, 6 months, 1 year, and 2 years). Subjects were queried regarding any AEs, SAEs, and reoperations of the index foot/ankle. Any AE resulting in reoperation or revision was recorded as an SAE. All reoperations were documented using the Surgical Reoperation Form.
|
|
Musculoskeletal and connective tissue disorders
Right ankle pain for months/years
|
0.70%
1/142 • Number of events 1 • Adverse event data were collected from the immediate postoperative period through the 6-week, 3-month, 6-month, 1 year, and 2-year follow-ups.
Adverse events (AEs) and serious adverse events (SAEs) were assessed during the immediate postoperative period and at scheduled follow-up visits (6 weeks, 3 months, 6 months, 1 year, and 2 years). Subjects were queried regarding any AEs, SAEs, and reoperations of the index foot/ankle. Any AE resulting in reoperation or revision was recorded as an SAE. All reoperations were documented using the Surgical Reoperation Form.
|
0.00%
0/6 • Adverse event data were collected from the immediate postoperative period through the 6-week, 3-month, 6-month, 1 year, and 2-year follow-ups.
Adverse events (AEs) and serious adverse events (SAEs) were assessed during the immediate postoperative period and at scheduled follow-up visits (6 weeks, 3 months, 6 months, 1 year, and 2 years). Subjects were queried regarding any AEs, SAEs, and reoperations of the index foot/ankle. Any AE resulting in reoperation or revision was recorded as an SAE. All reoperations were documented using the Surgical Reoperation Form.
|
Other adverse events
| Measure |
Subchondroplasty With AccuFill® (On-Label)
n=142 participants at risk
Subjects with at least one bone marrow lesion (BML) of any of the bones of the foot and/or ankle, who have elected to undergo or who have undergone the Subchondroplasty procedure using AccuFill® bone substitute material.
|
Subchondroplasty With AccuFill® (Off-Label)
n=6 participants at risk
Participants had ≥1 bone marrow lesion (BML) in the foot/ankle and underwent the Subchondroplasty® procedure using AccuFill® bone substitute material. Per the Instructions For Use (IFU), AccuFill® was intended to be mixed with blood or saline; however, some participants received off-label treatment where other materials (e.g., platelet rich plasma or bone marrow aspirate concentrate) were used.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Ankle instability
|
0.70%
1/142 • Number of events 1 • Adverse event data were collected from the immediate postoperative period through the 6-week, 3-month, 6-month, 1 year, and 2-year follow-ups.
Adverse events (AEs) and serious adverse events (SAEs) were assessed during the immediate postoperative period and at scheduled follow-up visits (6 weeks, 3 months, 6 months, 1 year, and 2 years). Subjects were queried regarding any AEs, SAEs, and reoperations of the index foot/ankle. Any AE resulting in reoperation or revision was recorded as an SAE. All reoperations were documented using the Surgical Reoperation Form.
|
0.00%
0/6 • Adverse event data were collected from the immediate postoperative period through the 6-week, 3-month, 6-month, 1 year, and 2-year follow-ups.
Adverse events (AEs) and serious adverse events (SAEs) were assessed during the immediate postoperative period and at scheduled follow-up visits (6 weeks, 3 months, 6 months, 1 year, and 2 years). Subjects were queried regarding any AEs, SAEs, and reoperations of the index foot/ankle. Any AE resulting in reoperation or revision was recorded as an SAE. All reoperations were documented using the Surgical Reoperation Form.
|
|
Musculoskeletal and connective tissue disorders
Plantar fasciitis
|
1.4%
2/142 • Number of events 2 • Adverse event data were collected from the immediate postoperative period through the 6-week, 3-month, 6-month, 1 year, and 2-year follow-ups.
Adverse events (AEs) and serious adverse events (SAEs) were assessed during the immediate postoperative period and at scheduled follow-up visits (6 weeks, 3 months, 6 months, 1 year, and 2 years). Subjects were queried regarding any AEs, SAEs, and reoperations of the index foot/ankle. Any AE resulting in reoperation or revision was recorded as an SAE. All reoperations were documented using the Surgical Reoperation Form.
|
0.00%
0/6 • Adverse event data were collected from the immediate postoperative period through the 6-week, 3-month, 6-month, 1 year, and 2-year follow-ups.
Adverse events (AEs) and serious adverse events (SAEs) were assessed during the immediate postoperative period and at scheduled follow-up visits (6 weeks, 3 months, 6 months, 1 year, and 2 years). Subjects were queried regarding any AEs, SAEs, and reoperations of the index foot/ankle. Any AE resulting in reoperation or revision was recorded as an SAE. All reoperations were documented using the Surgical Reoperation Form.
|
|
Musculoskeletal and connective tissue disorders
Sinus tarsi syndrome
|
1.4%
2/142 • Number of events 2 • Adverse event data were collected from the immediate postoperative period through the 6-week, 3-month, 6-month, 1 year, and 2-year follow-ups.
Adverse events (AEs) and serious adverse events (SAEs) were assessed during the immediate postoperative period and at scheduled follow-up visits (6 weeks, 3 months, 6 months, 1 year, and 2 years). Subjects were queried regarding any AEs, SAEs, and reoperations of the index foot/ankle. Any AE resulting in reoperation or revision was recorded as an SAE. All reoperations were documented using the Surgical Reoperation Form.
|
0.00%
0/6 • Adverse event data were collected from the immediate postoperative period through the 6-week, 3-month, 6-month, 1 year, and 2-year follow-ups.
Adverse events (AEs) and serious adverse events (SAEs) were assessed during the immediate postoperative period and at scheduled follow-up visits (6 weeks, 3 months, 6 months, 1 year, and 2 years). Subjects were queried regarding any AEs, SAEs, and reoperations of the index foot/ankle. Any AE resulting in reoperation or revision was recorded as an SAE. All reoperations were documented using the Surgical Reoperation Form.
|
|
Musculoskeletal and connective tissue disorders
Increase in VAS pain score
|
2.8%
4/142 • Number of events 4 • Adverse event data were collected from the immediate postoperative period through the 6-week, 3-month, 6-month, 1 year, and 2-year follow-ups.
Adverse events (AEs) and serious adverse events (SAEs) were assessed during the immediate postoperative period and at scheduled follow-up visits (6 weeks, 3 months, 6 months, 1 year, and 2 years). Subjects were queried regarding any AEs, SAEs, and reoperations of the index foot/ankle. Any AE resulting in reoperation or revision was recorded as an SAE. All reoperations were documented using the Surgical Reoperation Form.
|
0.00%
0/6 • Adverse event data were collected from the immediate postoperative period through the 6-week, 3-month, 6-month, 1 year, and 2-year follow-ups.
Adverse events (AEs) and serious adverse events (SAEs) were assessed during the immediate postoperative period and at scheduled follow-up visits (6 weeks, 3 months, 6 months, 1 year, and 2 years). Subjects were queried regarding any AEs, SAEs, and reoperations of the index foot/ankle. Any AE resulting in reoperation or revision was recorded as an SAE. All reoperations were documented using the Surgical Reoperation Form.
|
|
Musculoskeletal and connective tissue disorders
Increased numeric pain score postop
|
0.70%
1/142 • Number of events 1 • Adverse event data were collected from the immediate postoperative period through the 6-week, 3-month, 6-month, 1 year, and 2-year follow-ups.
Adverse events (AEs) and serious adverse events (SAEs) were assessed during the immediate postoperative period and at scheduled follow-up visits (6 weeks, 3 months, 6 months, 1 year, and 2 years). Subjects were queried regarding any AEs, SAEs, and reoperations of the index foot/ankle. Any AE resulting in reoperation or revision was recorded as an SAE. All reoperations were documented using the Surgical Reoperation Form.
|
0.00%
0/6 • Adverse event data were collected from the immediate postoperative period through the 6-week, 3-month, 6-month, 1 year, and 2-year follow-ups.
Adverse events (AEs) and serious adverse events (SAEs) were assessed during the immediate postoperative period and at scheduled follow-up visits (6 weeks, 3 months, 6 months, 1 year, and 2 years). Subjects were queried regarding any AEs, SAEs, and reoperations of the index foot/ankle. Any AE resulting in reoperation or revision was recorded as an SAE. All reoperations were documented using the Surgical Reoperation Form.
|
|
Musculoskeletal and connective tissue disorders
Increased VAS pain score due to increased activity
|
0.70%
1/142 • Number of events 1 • Adverse event data were collected from the immediate postoperative period through the 6-week, 3-month, 6-month, 1 year, and 2-year follow-ups.
Adverse events (AEs) and serious adverse events (SAEs) were assessed during the immediate postoperative period and at scheduled follow-up visits (6 weeks, 3 months, 6 months, 1 year, and 2 years). Subjects were queried regarding any AEs, SAEs, and reoperations of the index foot/ankle. Any AE resulting in reoperation or revision was recorded as an SAE. All reoperations were documented using the Surgical Reoperation Form.
|
0.00%
0/6 • Adverse event data were collected from the immediate postoperative period through the 6-week, 3-month, 6-month, 1 year, and 2-year follow-ups.
Adverse events (AEs) and serious adverse events (SAEs) were assessed during the immediate postoperative period and at scheduled follow-up visits (6 weeks, 3 months, 6 months, 1 year, and 2 years). Subjects were queried regarding any AEs, SAEs, and reoperations of the index foot/ankle. Any AE resulting in reoperation or revision was recorded as an SAE. All reoperations were documented using the Surgical Reoperation Form.
|
|
Musculoskeletal and connective tissue disorders
Increased VAS pain score
|
0.70%
1/142 • Number of events 1 • Adverse event data were collected from the immediate postoperative period through the 6-week, 3-month, 6-month, 1 year, and 2-year follow-ups.
Adverse events (AEs) and serious adverse events (SAEs) were assessed during the immediate postoperative period and at scheduled follow-up visits (6 weeks, 3 months, 6 months, 1 year, and 2 years). Subjects were queried regarding any AEs, SAEs, and reoperations of the index foot/ankle. Any AE resulting in reoperation or revision was recorded as an SAE. All reoperations were documented using the Surgical Reoperation Form.
|
0.00%
0/6 • Adverse event data were collected from the immediate postoperative period through the 6-week, 3-month, 6-month, 1 year, and 2-year follow-ups.
Adverse events (AEs) and serious adverse events (SAEs) were assessed during the immediate postoperative period and at scheduled follow-up visits (6 weeks, 3 months, 6 months, 1 year, and 2 years). Subjects were queried regarding any AEs, SAEs, and reoperations of the index foot/ankle. Any AE resulting in reoperation or revision was recorded as an SAE. All reoperations were documented using the Surgical Reoperation Form.
|
|
Musculoskeletal and connective tissue disorders
Pain score increased from baseline to 2 weeks
|
0.00%
0/142 • Adverse event data were collected from the immediate postoperative period through the 6-week, 3-month, 6-month, 1 year, and 2-year follow-ups.
Adverse events (AEs) and serious adverse events (SAEs) were assessed during the immediate postoperative period and at scheduled follow-up visits (6 weeks, 3 months, 6 months, 1 year, and 2 years). Subjects were queried regarding any AEs, SAEs, and reoperations of the index foot/ankle. Any AE resulting in reoperation or revision was recorded as an SAE. All reoperations were documented using the Surgical Reoperation Form.
|
16.7%
1/6 • Number of events 1 • Adverse event data were collected from the immediate postoperative period through the 6-week, 3-month, 6-month, 1 year, and 2-year follow-ups.
Adverse events (AEs) and serious adverse events (SAEs) were assessed during the immediate postoperative period and at scheduled follow-up visits (6 weeks, 3 months, 6 months, 1 year, and 2 years). Subjects were queried regarding any AEs, SAEs, and reoperations of the index foot/ankle. Any AE resulting in reoperation or revision was recorded as an SAE. All reoperations were documented using the Surgical Reoperation Form.
|
|
Musculoskeletal and connective tissue disorders
Patient numeric pain scale increased intensity with resolution
|
0.00%
0/142 • Adverse event data were collected from the immediate postoperative period through the 6-week, 3-month, 6-month, 1 year, and 2-year follow-ups.
Adverse events (AEs) and serious adverse events (SAEs) were assessed during the immediate postoperative period and at scheduled follow-up visits (6 weeks, 3 months, 6 months, 1 year, and 2 years). Subjects were queried regarding any AEs, SAEs, and reoperations of the index foot/ankle. Any AE resulting in reoperation or revision was recorded as an SAE. All reoperations were documented using the Surgical Reoperation Form.
|
16.7%
1/6 • Number of events 1 • Adverse event data were collected from the immediate postoperative period through the 6-week, 3-month, 6-month, 1 year, and 2-year follow-ups.
Adverse events (AEs) and serious adverse events (SAEs) were assessed during the immediate postoperative period and at scheduled follow-up visits (6 weeks, 3 months, 6 months, 1 year, and 2 years). Subjects were queried regarding any AEs, SAEs, and reoperations of the index foot/ankle. Any AE resulting in reoperation or revision was recorded as an SAE. All reoperations were documented using the Surgical Reoperation Form.
|
|
Musculoskeletal and connective tissue disorders
Increased pain scale postop with subsequent improvement
|
0.00%
0/142 • Adverse event data were collected from the immediate postoperative period through the 6-week, 3-month, 6-month, 1 year, and 2-year follow-ups.
Adverse events (AEs) and serious adverse events (SAEs) were assessed during the immediate postoperative period and at scheduled follow-up visits (6 weeks, 3 months, 6 months, 1 year, and 2 years). Subjects were queried regarding any AEs, SAEs, and reoperations of the index foot/ankle. Any AE resulting in reoperation or revision was recorded as an SAE. All reoperations were documented using the Surgical Reoperation Form.
|
16.7%
1/6 • Number of events 1 • Adverse event data were collected from the immediate postoperative period through the 6-week, 3-month, 6-month, 1 year, and 2-year follow-ups.
Adverse events (AEs) and serious adverse events (SAEs) were assessed during the immediate postoperative period and at scheduled follow-up visits (6 weeks, 3 months, 6 months, 1 year, and 2 years). Subjects were queried regarding any AEs, SAEs, and reoperations of the index foot/ankle. Any AE resulting in reoperation or revision was recorded as an SAE. All reoperations were documented using the Surgical Reoperation Form.
|
|
Musculoskeletal and connective tissue disorders
Post traumatic arthritis
|
1.4%
2/142 • Number of events 2 • Adverse event data were collected from the immediate postoperative period through the 6-week, 3-month, 6-month, 1 year, and 2-year follow-ups.
Adverse events (AEs) and serious adverse events (SAEs) were assessed during the immediate postoperative period and at scheduled follow-up visits (6 weeks, 3 months, 6 months, 1 year, and 2 years). Subjects were queried regarding any AEs, SAEs, and reoperations of the index foot/ankle. Any AE resulting in reoperation or revision was recorded as an SAE. All reoperations were documented using the Surgical Reoperation Form.
|
0.00%
0/6 • Adverse event data were collected from the immediate postoperative period through the 6-week, 3-month, 6-month, 1 year, and 2-year follow-ups.
Adverse events (AEs) and serious adverse events (SAEs) were assessed during the immediate postoperative period and at scheduled follow-up visits (6 weeks, 3 months, 6 months, 1 year, and 2 years). Subjects were queried regarding any AEs, SAEs, and reoperations of the index foot/ankle. Any AE resulting in reoperation or revision was recorded as an SAE. All reoperations were documented using the Surgical Reoperation Form.
|
|
Musculoskeletal and connective tissue disorders
Tendinitis
|
0.70%
1/142 • Number of events 1 • Adverse event data were collected from the immediate postoperative period through the 6-week, 3-month, 6-month, 1 year, and 2-year follow-ups.
Adverse events (AEs) and serious adverse events (SAEs) were assessed during the immediate postoperative period and at scheduled follow-up visits (6 weeks, 3 months, 6 months, 1 year, and 2 years). Subjects were queried regarding any AEs, SAEs, and reoperations of the index foot/ankle. Any AE resulting in reoperation or revision was recorded as an SAE. All reoperations were documented using the Surgical Reoperation Form.
|
0.00%
0/6 • Adverse event data were collected from the immediate postoperative period through the 6-week, 3-month, 6-month, 1 year, and 2-year follow-ups.
Adverse events (AEs) and serious adverse events (SAEs) were assessed during the immediate postoperative period and at scheduled follow-up visits (6 weeks, 3 months, 6 months, 1 year, and 2 years). Subjects were queried regarding any AEs, SAEs, and reoperations of the index foot/ankle. Any AE resulting in reoperation or revision was recorded as an SAE. All reoperations were documented using the Surgical Reoperation Form.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.70%
1/142 • Number of events 1 • Adverse event data were collected from the immediate postoperative period through the 6-week, 3-month, 6-month, 1 year, and 2-year follow-ups.
Adverse events (AEs) and serious adverse events (SAEs) were assessed during the immediate postoperative period and at scheduled follow-up visits (6 weeks, 3 months, 6 months, 1 year, and 2 years). Subjects were queried regarding any AEs, SAEs, and reoperations of the index foot/ankle. Any AE resulting in reoperation or revision was recorded as an SAE. All reoperations were documented using the Surgical Reoperation Form.
|
0.00%
0/6 • Adverse event data were collected from the immediate postoperative period through the 6-week, 3-month, 6-month, 1 year, and 2-year follow-ups.
Adverse events (AEs) and serious adverse events (SAEs) were assessed during the immediate postoperative period and at scheduled follow-up visits (6 weeks, 3 months, 6 months, 1 year, and 2 years). Subjects were queried regarding any AEs, SAEs, and reoperations of the index foot/ankle. Any AE resulting in reoperation or revision was recorded as an SAE. All reoperations were documented using the Surgical Reoperation Form.
|
|
Musculoskeletal and connective tissue disorders
No resolution in pain
|
0.70%
1/142 • Number of events 1 • Adverse event data were collected from the immediate postoperative period through the 6-week, 3-month, 6-month, 1 year, and 2-year follow-ups.
Adverse events (AEs) and serious adverse events (SAEs) were assessed during the immediate postoperative period and at scheduled follow-up visits (6 weeks, 3 months, 6 months, 1 year, and 2 years). Subjects were queried regarding any AEs, SAEs, and reoperations of the index foot/ankle. Any AE resulting in reoperation or revision was recorded as an SAE. All reoperations were documented using the Surgical Reoperation Form.
|
0.00%
0/6 • Adverse event data were collected from the immediate postoperative period through the 6-week, 3-month, 6-month, 1 year, and 2-year follow-ups.
Adverse events (AEs) and serious adverse events (SAEs) were assessed during the immediate postoperative period and at scheduled follow-up visits (6 weeks, 3 months, 6 months, 1 year, and 2 years). Subjects were queried regarding any AEs, SAEs, and reoperations of the index foot/ankle. Any AE resulting in reoperation or revision was recorded as an SAE. All reoperations were documented using the Surgical Reoperation Form.
|
|
Musculoskeletal and connective tissue disorders
Suspected Morton's neuroma
|
0.70%
1/142 • Number of events 1 • Adverse event data were collected from the immediate postoperative period through the 6-week, 3-month, 6-month, 1 year, and 2-year follow-ups.
Adverse events (AEs) and serious adverse events (SAEs) were assessed during the immediate postoperative period and at scheduled follow-up visits (6 weeks, 3 months, 6 months, 1 year, and 2 years). Subjects were queried regarding any AEs, SAEs, and reoperations of the index foot/ankle. Any AE resulting in reoperation or revision was recorded as an SAE. All reoperations were documented using the Surgical Reoperation Form.
|
0.00%
0/6 • Adverse event data were collected from the immediate postoperative period through the 6-week, 3-month, 6-month, 1 year, and 2-year follow-ups.
Adverse events (AEs) and serious adverse events (SAEs) were assessed during the immediate postoperative period and at scheduled follow-up visits (6 weeks, 3 months, 6 months, 1 year, and 2 years). Subjects were queried regarding any AEs, SAEs, and reoperations of the index foot/ankle. Any AE resulting in reoperation or revision was recorded as an SAE. All reoperations were documented using the Surgical Reoperation Form.
|
|
Musculoskeletal and connective tissue disorders
Morton's Neuroma, right
|
0.70%
1/142 • Number of events 1 • Adverse event data were collected from the immediate postoperative period through the 6-week, 3-month, 6-month, 1 year, and 2-year follow-ups.
Adverse events (AEs) and serious adverse events (SAEs) were assessed during the immediate postoperative period and at scheduled follow-up visits (6 weeks, 3 months, 6 months, 1 year, and 2 years). Subjects were queried regarding any AEs, SAEs, and reoperations of the index foot/ankle. Any AE resulting in reoperation or revision was recorded as an SAE. All reoperations were documented using the Surgical Reoperation Form.
|
0.00%
0/6 • Adverse event data were collected from the immediate postoperative period through the 6-week, 3-month, 6-month, 1 year, and 2-year follow-ups.
Adverse events (AEs) and serious adverse events (SAEs) were assessed during the immediate postoperative period and at scheduled follow-up visits (6 weeks, 3 months, 6 months, 1 year, and 2 years). Subjects were queried regarding any AEs, SAEs, and reoperations of the index foot/ankle. Any AE resulting in reoperation or revision was recorded as an SAE. All reoperations were documented using the Surgical Reoperation Form.
|
|
Musculoskeletal and connective tissue disorders
Expected routine postoperative pain
|
0.70%
1/142 • Number of events 1 • Adverse event data were collected from the immediate postoperative period through the 6-week, 3-month, 6-month, 1 year, and 2-year follow-ups.
Adverse events (AEs) and serious adverse events (SAEs) were assessed during the immediate postoperative period and at scheduled follow-up visits (6 weeks, 3 months, 6 months, 1 year, and 2 years). Subjects were queried regarding any AEs, SAEs, and reoperations of the index foot/ankle. Any AE resulting in reoperation or revision was recorded as an SAE. All reoperations were documented using the Surgical Reoperation Form.
|
0.00%
0/6 • Adverse event data were collected from the immediate postoperative period through the 6-week, 3-month, 6-month, 1 year, and 2-year follow-ups.
Adverse events (AEs) and serious adverse events (SAEs) were assessed during the immediate postoperative period and at scheduled follow-up visits (6 weeks, 3 months, 6 months, 1 year, and 2 years). Subjects were queried regarding any AEs, SAEs, and reoperations of the index foot/ankle. Any AE resulting in reoperation or revision was recorded as an SAE. All reoperations were documented using the Surgical Reoperation Form.
|
|
Musculoskeletal and connective tissue disorders
Posterolateral ankle pain
|
0.70%
1/142 • Number of events 1 • Adverse event data were collected from the immediate postoperative period through the 6-week, 3-month, 6-month, 1 year, and 2-year follow-ups.
Adverse events (AEs) and serious adverse events (SAEs) were assessed during the immediate postoperative period and at scheduled follow-up visits (6 weeks, 3 months, 6 months, 1 year, and 2 years). Subjects were queried regarding any AEs, SAEs, and reoperations of the index foot/ankle. Any AE resulting in reoperation or revision was recorded as an SAE. All reoperations were documented using the Surgical Reoperation Form.
|
0.00%
0/6 • Adverse event data were collected from the immediate postoperative period through the 6-week, 3-month, 6-month, 1 year, and 2-year follow-ups.
Adverse events (AEs) and serious adverse events (SAEs) were assessed during the immediate postoperative period and at scheduled follow-up visits (6 weeks, 3 months, 6 months, 1 year, and 2 years). Subjects were queried regarding any AEs, SAEs, and reoperations of the index foot/ankle. Any AE resulting in reoperation or revision was recorded as an SAE. All reoperations were documented using the Surgical Reoperation Form.
|
|
Musculoskeletal and connective tissue disorders
First MTP pain with increased activity
|
0.70%
1/142 • Number of events 1 • Adverse event data were collected from the immediate postoperative period through the 6-week, 3-month, 6-month, 1 year, and 2-year follow-ups.
Adverse events (AEs) and serious adverse events (SAEs) were assessed during the immediate postoperative period and at scheduled follow-up visits (6 weeks, 3 months, 6 months, 1 year, and 2 years). Subjects were queried regarding any AEs, SAEs, and reoperations of the index foot/ankle. Any AE resulting in reoperation or revision was recorded as an SAE. All reoperations were documented using the Surgical Reoperation Form.
|
0.00%
0/6 • Adverse event data were collected from the immediate postoperative period through the 6-week, 3-month, 6-month, 1 year, and 2-year follow-ups.
Adverse events (AEs) and serious adverse events (SAEs) were assessed during the immediate postoperative period and at scheduled follow-up visits (6 weeks, 3 months, 6 months, 1 year, and 2 years). Subjects were queried regarding any AEs, SAEs, and reoperations of the index foot/ankle. Any AE resulting in reoperation or revision was recorded as an SAE. All reoperations were documented using the Surgical Reoperation Form.
|
|
Musculoskeletal and connective tissue disorders
Further ankle surgery (right)
|
0.70%
1/142 • Number of events 1 • Adverse event data were collected from the immediate postoperative period through the 6-week, 3-month, 6-month, 1 year, and 2-year follow-ups.
Adverse events (AEs) and serious adverse events (SAEs) were assessed during the immediate postoperative period and at scheduled follow-up visits (6 weeks, 3 months, 6 months, 1 year, and 2 years). Subjects were queried regarding any AEs, SAEs, and reoperations of the index foot/ankle. Any AE resulting in reoperation or revision was recorded as an SAE. All reoperations were documented using the Surgical Reoperation Form.
|
0.00%
0/6 • Adverse event data were collected from the immediate postoperative period through the 6-week, 3-month, 6-month, 1 year, and 2-year follow-ups.
Adverse events (AEs) and serious adverse events (SAEs) were assessed during the immediate postoperative period and at scheduled follow-up visits (6 weeks, 3 months, 6 months, 1 year, and 2 years). Subjects were queried regarding any AEs, SAEs, and reoperations of the index foot/ankle. Any AE resulting in reoperation or revision was recorded as an SAE. All reoperations were documented using the Surgical Reoperation Form.
|
|
Musculoskeletal and connective tissue disorders
Small spur on the lateral foot causing shoe gear irritation
|
0.70%
1/142 • Number of events 1 • Adverse event data were collected from the immediate postoperative period through the 6-week, 3-month, 6-month, 1 year, and 2-year follow-ups.
Adverse events (AEs) and serious adverse events (SAEs) were assessed during the immediate postoperative period and at scheduled follow-up visits (6 weeks, 3 months, 6 months, 1 year, and 2 years). Subjects were queried regarding any AEs, SAEs, and reoperations of the index foot/ankle. Any AE resulting in reoperation or revision was recorded as an SAE. All reoperations were documented using the Surgical Reoperation Form.
|
0.00%
0/6 • Adverse event data were collected from the immediate postoperative period through the 6-week, 3-month, 6-month, 1 year, and 2-year follow-ups.
Adverse events (AEs) and serious adverse events (SAEs) were assessed during the immediate postoperative period and at scheduled follow-up visits (6 weeks, 3 months, 6 months, 1 year, and 2 years). Subjects were queried regarding any AEs, SAEs, and reoperations of the index foot/ankle. Any AE resulting in reoperation or revision was recorded as an SAE. All reoperations were documented using the Surgical Reoperation Form.
|
|
Musculoskeletal and connective tissue disorders
Pain and inflammation of surgically treated foot
|
0.70%
1/142 • Number of events 1 • Adverse event data were collected from the immediate postoperative period through the 6-week, 3-month, 6-month, 1 year, and 2-year follow-ups.
Adverse events (AEs) and serious adverse events (SAEs) were assessed during the immediate postoperative period and at scheduled follow-up visits (6 weeks, 3 months, 6 months, 1 year, and 2 years). Subjects were queried regarding any AEs, SAEs, and reoperations of the index foot/ankle. Any AE resulting in reoperation or revision was recorded as an SAE. All reoperations were documented using the Surgical Reoperation Form.
|
0.00%
0/6 • Adverse event data were collected from the immediate postoperative period through the 6-week, 3-month, 6-month, 1 year, and 2-year follow-ups.
Adverse events (AEs) and serious adverse events (SAEs) were assessed during the immediate postoperative period and at scheduled follow-up visits (6 weeks, 3 months, 6 months, 1 year, and 2 years). Subjects were queried regarding any AEs, SAEs, and reoperations of the index foot/ankle. Any AE resulting in reoperation or revision was recorded as an SAE. All reoperations were documented using the Surgical Reoperation Form.
|
|
Musculoskeletal and connective tissue disorders
MCJ Arthritis
|
0.70%
1/142 • Number of events 1 • Adverse event data were collected from the immediate postoperative period through the 6-week, 3-month, 6-month, 1 year, and 2-year follow-ups.
Adverse events (AEs) and serious adverse events (SAEs) were assessed during the immediate postoperative period and at scheduled follow-up visits (6 weeks, 3 months, 6 months, 1 year, and 2 years). Subjects were queried regarding any AEs, SAEs, and reoperations of the index foot/ankle. Any AE resulting in reoperation or revision was recorded as an SAE. All reoperations were documented using the Surgical Reoperation Form.
|
0.00%
0/6 • Adverse event data were collected from the immediate postoperative period through the 6-week, 3-month, 6-month, 1 year, and 2-year follow-ups.
Adverse events (AEs) and serious adverse events (SAEs) were assessed during the immediate postoperative period and at scheduled follow-up visits (6 weeks, 3 months, 6 months, 1 year, and 2 years). Subjects were queried regarding any AEs, SAEs, and reoperations of the index foot/ankle. Any AE resulting in reoperation or revision was recorded as an SAE. All reoperations were documented using the Surgical Reoperation Form.
|
|
Musculoskeletal and connective tissue disorders
New fracture in the cuboid bone (operative foot)
|
0.70%
1/142 • Number of events 1 • Adverse event data were collected from the immediate postoperative period through the 6-week, 3-month, 6-month, 1 year, and 2-year follow-ups.
Adverse events (AEs) and serious adverse events (SAEs) were assessed during the immediate postoperative period and at scheduled follow-up visits (6 weeks, 3 months, 6 months, 1 year, and 2 years). Subjects were queried regarding any AEs, SAEs, and reoperations of the index foot/ankle. Any AE resulting in reoperation or revision was recorded as an SAE. All reoperations were documented using the Surgical Reoperation Form.
|
0.00%
0/6 • Adverse event data were collected from the immediate postoperative period through the 6-week, 3-month, 6-month, 1 year, and 2-year follow-ups.
Adverse events (AEs) and serious adverse events (SAEs) were assessed during the immediate postoperative period and at scheduled follow-up visits (6 weeks, 3 months, 6 months, 1 year, and 2 years). Subjects were queried regarding any AEs, SAEs, and reoperations of the index foot/ankle. Any AE resulting in reoperation or revision was recorded as an SAE. All reoperations were documented using the Surgical Reoperation Form.
|
|
Musculoskeletal and connective tissue disorders
Peroneal tendon repair surgery (left foot)
|
0.70%
1/142 • Number of events 1 • Adverse event data were collected from the immediate postoperative period through the 6-week, 3-month, 6-month, 1 year, and 2-year follow-ups.
Adverse events (AEs) and serious adverse events (SAEs) were assessed during the immediate postoperative period and at scheduled follow-up visits (6 weeks, 3 months, 6 months, 1 year, and 2 years). Subjects were queried regarding any AEs, SAEs, and reoperations of the index foot/ankle. Any AE resulting in reoperation or revision was recorded as an SAE. All reoperations were documented using the Surgical Reoperation Form.
|
0.00%
0/6 • Adverse event data were collected from the immediate postoperative period through the 6-week, 3-month, 6-month, 1 year, and 2-year follow-ups.
Adverse events (AEs) and serious adverse events (SAEs) were assessed during the immediate postoperative period and at scheduled follow-up visits (6 weeks, 3 months, 6 months, 1 year, and 2 years). Subjects were queried regarding any AEs, SAEs, and reoperations of the index foot/ankle. Any AE resulting in reoperation or revision was recorded as an SAE. All reoperations were documented using the Surgical Reoperation Form.
|
|
Injury, poisoning and procedural complications
Cortical perforation during cannula placement
|
0.70%
1/142 • Number of events 1 • Adverse event data were collected from the immediate postoperative period through the 6-week, 3-month, 6-month, 1 year, and 2-year follow-ups.
Adverse events (AEs) and serious adverse events (SAEs) were assessed during the immediate postoperative period and at scheduled follow-up visits (6 weeks, 3 months, 6 months, 1 year, and 2 years). Subjects were queried regarding any AEs, SAEs, and reoperations of the index foot/ankle. Any AE resulting in reoperation or revision was recorded as an SAE. All reoperations were documented using the Surgical Reoperation Form.
|
0.00%
0/6 • Adverse event data were collected from the immediate postoperative period through the 6-week, 3-month, 6-month, 1 year, and 2-year follow-ups.
Adverse events (AEs) and serious adverse events (SAEs) were assessed during the immediate postoperative period and at scheduled follow-up visits (6 weeks, 3 months, 6 months, 1 year, and 2 years). Subjects were queried regarding any AEs, SAEs, and reoperations of the index foot/ankle. Any AE resulting in reoperation or revision was recorded as an SAE. All reoperations were documented using the Surgical Reoperation Form.
|
|
Musculoskeletal and connective tissue disorders
Pain score at 3 month is higher than baseline
|
0.70%
1/142 • Number of events 1 • Adverse event data were collected from the immediate postoperative period through the 6-week, 3-month, 6-month, 1 year, and 2-year follow-ups.
Adverse events (AEs) and serious adverse events (SAEs) were assessed during the immediate postoperative period and at scheduled follow-up visits (6 weeks, 3 months, 6 months, 1 year, and 2 years). Subjects were queried regarding any AEs, SAEs, and reoperations of the index foot/ankle. Any AE resulting in reoperation or revision was recorded as an SAE. All reoperations were documented using the Surgical Reoperation Form.
|
0.00%
0/6 • Adverse event data were collected from the immediate postoperative period through the 6-week, 3-month, 6-month, 1 year, and 2-year follow-ups.
Adverse events (AEs) and serious adverse events (SAEs) were assessed during the immediate postoperative period and at scheduled follow-up visits (6 weeks, 3 months, 6 months, 1 year, and 2 years). Subjects were queried regarding any AEs, SAEs, and reoperations of the index foot/ankle. Any AE resulting in reoperation or revision was recorded as an SAE. All reoperations were documented using the Surgical Reoperation Form.
|
|
Musculoskeletal and connective tissue disorders
Sinus tarsi inflammation (Left foot)
|
0.70%
1/142 • Number of events 1 • Adverse event data were collected from the immediate postoperative period through the 6-week, 3-month, 6-month, 1 year, and 2-year follow-ups.
Adverse events (AEs) and serious adverse events (SAEs) were assessed during the immediate postoperative period and at scheduled follow-up visits (6 weeks, 3 months, 6 months, 1 year, and 2 years). Subjects were queried regarding any AEs, SAEs, and reoperations of the index foot/ankle. Any AE resulting in reoperation or revision was recorded as an SAE. All reoperations were documented using the Surgical Reoperation Form.
|
0.00%
0/6 • Adverse event data were collected from the immediate postoperative period through the 6-week, 3-month, 6-month, 1 year, and 2-year follow-ups.
Adverse events (AEs) and serious adverse events (SAEs) were assessed during the immediate postoperative period and at scheduled follow-up visits (6 weeks, 3 months, 6 months, 1 year, and 2 years). Subjects were queried regarding any AEs, SAEs, and reoperations of the index foot/ankle. Any AE resulting in reoperation or revision was recorded as an SAE. All reoperations were documented using the Surgical Reoperation Form.
|
|
Musculoskeletal and connective tissue disorders
Small abscess/cellulitis on upper left calf due
|
0.70%
1/142 • Number of events 1 • Adverse event data were collected from the immediate postoperative period through the 6-week, 3-month, 6-month, 1 year, and 2-year follow-ups.
Adverse events (AEs) and serious adverse events (SAEs) were assessed during the immediate postoperative period and at scheduled follow-up visits (6 weeks, 3 months, 6 months, 1 year, and 2 years). Subjects were queried regarding any AEs, SAEs, and reoperations of the index foot/ankle. Any AE resulting in reoperation or revision was recorded as an SAE. All reoperations were documented using the Surgical Reoperation Form.
|
0.00%
0/6 • Adverse event data were collected from the immediate postoperative period through the 6-week, 3-month, 6-month, 1 year, and 2-year follow-ups.
Adverse events (AEs) and serious adverse events (SAEs) were assessed during the immediate postoperative period and at scheduled follow-up visits (6 weeks, 3 months, 6 months, 1 year, and 2 years). Subjects were queried regarding any AEs, SAEs, and reoperations of the index foot/ankle. Any AE resulting in reoperation or revision was recorded as an SAE. All reoperations were documented using the Surgical Reoperation Form.
|
|
Musculoskeletal and connective tissue disorders
Worsening of pain and decreased mobility
|
0.70%
1/142 • Number of events 1 • Adverse event data were collected from the immediate postoperative period through the 6-week, 3-month, 6-month, 1 year, and 2-year follow-ups.
Adverse events (AEs) and serious adverse events (SAEs) were assessed during the immediate postoperative period and at scheduled follow-up visits (6 weeks, 3 months, 6 months, 1 year, and 2 years). Subjects were queried regarding any AEs, SAEs, and reoperations of the index foot/ankle. Any AE resulting in reoperation or revision was recorded as an SAE. All reoperations were documented using the Surgical Reoperation Form.
|
0.00%
0/6 • Adverse event data were collected from the immediate postoperative period through the 6-week, 3-month, 6-month, 1 year, and 2-year follow-ups.
Adverse events (AEs) and serious adverse events (SAEs) were assessed during the immediate postoperative period and at scheduled follow-up visits (6 weeks, 3 months, 6 months, 1 year, and 2 years). Subjects were queried regarding any AEs, SAEs, and reoperations of the index foot/ankle. Any AE resulting in reoperation or revision was recorded as an SAE. All reoperations were documented using the Surgical Reoperation Form.
|
|
Psychiatric disorders
Nocturnal seizure
|
0.70%
1/142 • Number of events 1 • Adverse event data were collected from the immediate postoperative period through the 6-week, 3-month, 6-month, 1 year, and 2-year follow-ups.
Adverse events (AEs) and serious adverse events (SAEs) were assessed during the immediate postoperative period and at scheduled follow-up visits (6 weeks, 3 months, 6 months, 1 year, and 2 years). Subjects were queried regarding any AEs, SAEs, and reoperations of the index foot/ankle. Any AE resulting in reoperation or revision was recorded as an SAE. All reoperations were documented using the Surgical Reoperation Form.
|
0.00%
0/6 • Adverse event data were collected from the immediate postoperative period through the 6-week, 3-month, 6-month, 1 year, and 2-year follow-ups.
Adverse events (AEs) and serious adverse events (SAEs) were assessed during the immediate postoperative period and at scheduled follow-up visits (6 weeks, 3 months, 6 months, 1 year, and 2 years). Subjects were queried regarding any AEs, SAEs, and reoperations of the index foot/ankle. Any AE resulting in reoperation or revision was recorded as an SAE. All reoperations were documented using the Surgical Reoperation Form.
|
|
Musculoskeletal and connective tissue disorders
X-ray finding of minimal extravasation...of the right ankle
|
0.70%
1/142 • Number of events 1 • Adverse event data were collected from the immediate postoperative period through the 6-week, 3-month, 6-month, 1 year, and 2-year follow-ups.
Adverse events (AEs) and serious adverse events (SAEs) were assessed during the immediate postoperative period and at scheduled follow-up visits (6 weeks, 3 months, 6 months, 1 year, and 2 years). Subjects were queried regarding any AEs, SAEs, and reoperations of the index foot/ankle. Any AE resulting in reoperation or revision was recorded as an SAE. All reoperations were documented using the Surgical Reoperation Form.
|
0.00%
0/6 • Adverse event data were collected from the immediate postoperative period through the 6-week, 3-month, 6-month, 1 year, and 2-year follow-ups.
Adverse events (AEs) and serious adverse events (SAEs) were assessed during the immediate postoperative period and at scheduled follow-up visits (6 weeks, 3 months, 6 months, 1 year, and 2 years). Subjects were queried regarding any AEs, SAEs, and reoperations of the index foot/ankle. Any AE resulting in reoperation or revision was recorded as an SAE. All reoperations were documented using the Surgical Reoperation Form.
|
|
Musculoskeletal and connective tissue disorders
Increased pain in foot/ankle after ambulation
|
0.70%
1/142 • Number of events 1 • Adverse event data were collected from the immediate postoperative period through the 6-week, 3-month, 6-month, 1 year, and 2-year follow-ups.
Adverse events (AEs) and serious adverse events (SAEs) were assessed during the immediate postoperative period and at scheduled follow-up visits (6 weeks, 3 months, 6 months, 1 year, and 2 years). Subjects were queried regarding any AEs, SAEs, and reoperations of the index foot/ankle. Any AE resulting in reoperation or revision was recorded as an SAE. All reoperations were documented using the Surgical Reoperation Form.
|
0.00%
0/6 • Adverse event data were collected from the immediate postoperative period through the 6-week, 3-month, 6-month, 1 year, and 2-year follow-ups.
Adverse events (AEs) and serious adverse events (SAEs) were assessed during the immediate postoperative period and at scheduled follow-up visits (6 weeks, 3 months, 6 months, 1 year, and 2 years). Subjects were queried regarding any AEs, SAEs, and reoperations of the index foot/ankle. Any AE resulting in reoperation or revision was recorded as an SAE. All reoperations were documented using the Surgical Reoperation Form.
|
|
Musculoskeletal and connective tissue disorders
Pain overlying left cuboid
|
0.70%
1/142 • Number of events 1 • Adverse event data were collected from the immediate postoperative period through the 6-week, 3-month, 6-month, 1 year, and 2-year follow-ups.
Adverse events (AEs) and serious adverse events (SAEs) were assessed during the immediate postoperative period and at scheduled follow-up visits (6 weeks, 3 months, 6 months, 1 year, and 2 years). Subjects were queried regarding any AEs, SAEs, and reoperations of the index foot/ankle. Any AE resulting in reoperation or revision was recorded as an SAE. All reoperations were documented using the Surgical Reoperation Form.
|
0.00%
0/6 • Adverse event data were collected from the immediate postoperative period through the 6-week, 3-month, 6-month, 1 year, and 2-year follow-ups.
Adverse events (AEs) and serious adverse events (SAEs) were assessed during the immediate postoperative period and at scheduled follow-up visits (6 weeks, 3 months, 6 months, 1 year, and 2 years). Subjects were queried regarding any AEs, SAEs, and reoperations of the index foot/ankle. Any AE resulting in reoperation or revision was recorded as an SAE. All reoperations were documented using the Surgical Reoperation Form.
|
|
Musculoskeletal and connective tissue disorders
Left tarsal tunnel syndrome with bone marrow edema
|
0.70%
1/142 • Number of events 1 • Adverse event data were collected from the immediate postoperative period through the 6-week, 3-month, 6-month, 1 year, and 2-year follow-ups.
Adverse events (AEs) and serious adverse events (SAEs) were assessed during the immediate postoperative period and at scheduled follow-up visits (6 weeks, 3 months, 6 months, 1 year, and 2 years). Subjects were queried regarding any AEs, SAEs, and reoperations of the index foot/ankle. Any AE resulting in reoperation or revision was recorded as an SAE. All reoperations were documented using the Surgical Reoperation Form.
|
0.00%
0/6 • Adverse event data were collected from the immediate postoperative period through the 6-week, 3-month, 6-month, 1 year, and 2-year follow-ups.
Adverse events (AEs) and serious adverse events (SAEs) were assessed during the immediate postoperative period and at scheduled follow-up visits (6 weeks, 3 months, 6 months, 1 year, and 2 years). Subjects were queried regarding any AEs, SAEs, and reoperations of the index foot/ankle. Any AE resulting in reoperation or revision was recorded as an SAE. All reoperations were documented using the Surgical Reoperation Form.
|
|
Musculoskeletal and connective tissue disorders
Severe erythema of left ankle (non-study) site incision
|
0.70%
1/142 • Number of events 1 • Adverse event data were collected from the immediate postoperative period through the 6-week, 3-month, 6-month, 1 year, and 2-year follow-ups.
Adverse events (AEs) and serious adverse events (SAEs) were assessed during the immediate postoperative period and at scheduled follow-up visits (6 weeks, 3 months, 6 months, 1 year, and 2 years). Subjects were queried regarding any AEs, SAEs, and reoperations of the index foot/ankle. Any AE resulting in reoperation or revision was recorded as an SAE. All reoperations were documented using the Surgical Reoperation Form.
|
0.00%
0/6 • Adverse event data were collected from the immediate postoperative period through the 6-week, 3-month, 6-month, 1 year, and 2-year follow-ups.
Adverse events (AEs) and serious adverse events (SAEs) were assessed during the immediate postoperative period and at scheduled follow-up visits (6 weeks, 3 months, 6 months, 1 year, and 2 years). Subjects were queried regarding any AEs, SAEs, and reoperations of the index foot/ankle. Any AE resulting in reoperation or revision was recorded as an SAE. All reoperations were documented using the Surgical Reoperation Form.
|
|
Injury, poisoning and procedural complications
Wound dehiscence with drainage
|
0.70%
1/142 • Number of events 1 • Adverse event data were collected from the immediate postoperative period through the 6-week, 3-month, 6-month, 1 year, and 2-year follow-ups.
Adverse events (AEs) and serious adverse events (SAEs) were assessed during the immediate postoperative period and at scheduled follow-up visits (6 weeks, 3 months, 6 months, 1 year, and 2 years). Subjects were queried regarding any AEs, SAEs, and reoperations of the index foot/ankle. Any AE resulting in reoperation or revision was recorded as an SAE. All reoperations were documented using the Surgical Reoperation Form.
|
0.00%
0/6 • Adverse event data were collected from the immediate postoperative period through the 6-week, 3-month, 6-month, 1 year, and 2-year follow-ups.
Adverse events (AEs) and serious adverse events (SAEs) were assessed during the immediate postoperative period and at scheduled follow-up visits (6 weeks, 3 months, 6 months, 1 year, and 2 years). Subjects were queried regarding any AEs, SAEs, and reoperations of the index foot/ankle. Any AE resulting in reoperation or revision was recorded as an SAE. All reoperations were documented using the Surgical Reoperation Form.
|
|
Musculoskeletal and connective tissue disorders
Bursitis (right ankle)
|
0.70%
1/142 • Number of events 1 • Adverse event data were collected from the immediate postoperative period through the 6-week, 3-month, 6-month, 1 year, and 2-year follow-ups.
Adverse events (AEs) and serious adverse events (SAEs) were assessed during the immediate postoperative period and at scheduled follow-up visits (6 weeks, 3 months, 6 months, 1 year, and 2 years). Subjects were queried regarding any AEs, SAEs, and reoperations of the index foot/ankle. Any AE resulting in reoperation or revision was recorded as an SAE. All reoperations were documented using the Surgical Reoperation Form.
|
0.00%
0/6 • Adverse event data were collected from the immediate postoperative period through the 6-week, 3-month, 6-month, 1 year, and 2-year follow-ups.
Adverse events (AEs) and serious adverse events (SAEs) were assessed during the immediate postoperative period and at scheduled follow-up visits (6 weeks, 3 months, 6 months, 1 year, and 2 years). Subjects were queried regarding any AEs, SAEs, and reoperations of the index foot/ankle. Any AE resulting in reoperation or revision was recorded as an SAE. All reoperations were documented using the Surgical Reoperation Form.
|
|
Musculoskeletal and connective tissue disorders
Attenuation/scarring of posterior right tibial tendon
|
0.70%
1/142 • Number of events 1 • Adverse event data were collected from the immediate postoperative period through the 6-week, 3-month, 6-month, 1 year, and 2-year follow-ups.
Adverse events (AEs) and serious adverse events (SAEs) were assessed during the immediate postoperative period and at scheduled follow-up visits (6 weeks, 3 months, 6 months, 1 year, and 2 years). Subjects were queried regarding any AEs, SAEs, and reoperations of the index foot/ankle. Any AE resulting in reoperation or revision was recorded as an SAE. All reoperations were documented using the Surgical Reoperation Form.
|
0.00%
0/6 • Adverse event data were collected from the immediate postoperative period through the 6-week, 3-month, 6-month, 1 year, and 2-year follow-ups.
Adverse events (AEs) and serious adverse events (SAEs) were assessed during the immediate postoperative period and at scheduled follow-up visits (6 weeks, 3 months, 6 months, 1 year, and 2 years). Subjects were queried regarding any AEs, SAEs, and reoperations of the index foot/ankle. Any AE resulting in reoperation or revision was recorded as an SAE. All reoperations were documented using the Surgical Reoperation Form.
|
|
Musculoskeletal and connective tissue disorders
Pain (Left Ankle)
|
0.70%
1/142 • Number of events 1 • Adverse event data were collected from the immediate postoperative period through the 6-week, 3-month, 6-month, 1 year, and 2-year follow-ups.
Adverse events (AEs) and serious adverse events (SAEs) were assessed during the immediate postoperative period and at scheduled follow-up visits (6 weeks, 3 months, 6 months, 1 year, and 2 years). Subjects were queried regarding any AEs, SAEs, and reoperations of the index foot/ankle. Any AE resulting in reoperation or revision was recorded as an SAE. All reoperations were documented using the Surgical Reoperation Form.
|
0.00%
0/6 • Adverse event data were collected from the immediate postoperative period through the 6-week, 3-month, 6-month, 1 year, and 2-year follow-ups.
Adverse events (AEs) and serious adverse events (SAEs) were assessed during the immediate postoperative period and at scheduled follow-up visits (6 weeks, 3 months, 6 months, 1 year, and 2 years). Subjects were queried regarding any AEs, SAEs, and reoperations of the index foot/ankle. Any AE resulting in reoperation or revision was recorded as an SAE. All reoperations were documented using the Surgical Reoperation Form.
|
|
Injury, poisoning and procedural complications
Right medial ankle erythema
|
0.70%
1/142 • Number of events 1 • Adverse event data were collected from the immediate postoperative period through the 6-week, 3-month, 6-month, 1 year, and 2-year follow-ups.
Adverse events (AEs) and serious adverse events (SAEs) were assessed during the immediate postoperative period and at scheduled follow-up visits (6 weeks, 3 months, 6 months, 1 year, and 2 years). Subjects were queried regarding any AEs, SAEs, and reoperations of the index foot/ankle. Any AE resulting in reoperation or revision was recorded as an SAE. All reoperations were documented using the Surgical Reoperation Form.
|
0.00%
0/6 • Adverse event data were collected from the immediate postoperative period through the 6-week, 3-month, 6-month, 1 year, and 2-year follow-ups.
Adverse events (AEs) and serious adverse events (SAEs) were assessed during the immediate postoperative period and at scheduled follow-up visits (6 weeks, 3 months, 6 months, 1 year, and 2 years). Subjects were queried regarding any AEs, SAEs, and reoperations of the index foot/ankle. Any AE resulting in reoperation or revision was recorded as an SAE. All reoperations were documented using the Surgical Reoperation Form.
|
|
Injury, poisoning and procedural complications
1 inch superficial non healing wound
|
0.70%
1/142 • Number of events 1 • Adverse event data were collected from the immediate postoperative period through the 6-week, 3-month, 6-month, 1 year, and 2-year follow-ups.
Adverse events (AEs) and serious adverse events (SAEs) were assessed during the immediate postoperative period and at scheduled follow-up visits (6 weeks, 3 months, 6 months, 1 year, and 2 years). Subjects were queried regarding any AEs, SAEs, and reoperations of the index foot/ankle. Any AE resulting in reoperation or revision was recorded as an SAE. All reoperations were documented using the Surgical Reoperation Form.
|
16.7%
1/6 • Number of events 1 • Adverse event data were collected from the immediate postoperative period through the 6-week, 3-month, 6-month, 1 year, and 2-year follow-ups.
Adverse events (AEs) and serious adverse events (SAEs) were assessed during the immediate postoperative period and at scheduled follow-up visits (6 weeks, 3 months, 6 months, 1 year, and 2 years). Subjects were queried regarding any AEs, SAEs, and reoperations of the index foot/ankle. Any AE resulting in reoperation or revision was recorded as an SAE. All reoperations were documented using the Surgical Reoperation Form.
|
|
Musculoskeletal and connective tissue disorders
increased pain at the metatarsal ORIF surgical site
|
0.70%
1/142 • Number of events 1 • Adverse event data were collected from the immediate postoperative period through the 6-week, 3-month, 6-month, 1 year, and 2-year follow-ups.
Adverse events (AEs) and serious adverse events (SAEs) were assessed during the immediate postoperative period and at scheduled follow-up visits (6 weeks, 3 months, 6 months, 1 year, and 2 years). Subjects were queried regarding any AEs, SAEs, and reoperations of the index foot/ankle. Any AE resulting in reoperation or revision was recorded as an SAE. All reoperations were documented using the Surgical Reoperation Form.
|
0.00%
0/6 • Adverse event data were collected from the immediate postoperative period through the 6-week, 3-month, 6-month, 1 year, and 2-year follow-ups.
Adverse events (AEs) and serious adverse events (SAEs) were assessed during the immediate postoperative period and at scheduled follow-up visits (6 weeks, 3 months, 6 months, 1 year, and 2 years). Subjects were queried regarding any AEs, SAEs, and reoperations of the index foot/ankle. Any AE resulting in reoperation or revision was recorded as an SAE. All reoperations were documented using the Surgical Reoperation Form.
|
|
Injury, poisoning and procedural complications
Fall
|
0.70%
1/142 • Number of events 1 • Adverse event data were collected from the immediate postoperative period through the 6-week, 3-month, 6-month, 1 year, and 2-year follow-ups.
Adverse events (AEs) and serious adverse events (SAEs) were assessed during the immediate postoperative period and at scheduled follow-up visits (6 weeks, 3 months, 6 months, 1 year, and 2 years). Subjects were queried regarding any AEs, SAEs, and reoperations of the index foot/ankle. Any AE resulting in reoperation or revision was recorded as an SAE. All reoperations were documented using the Surgical Reoperation Form.
|
0.00%
0/6 • Adverse event data were collected from the immediate postoperative period through the 6-week, 3-month, 6-month, 1 year, and 2-year follow-ups.
Adverse events (AEs) and serious adverse events (SAEs) were assessed during the immediate postoperative period and at scheduled follow-up visits (6 weeks, 3 months, 6 months, 1 year, and 2 years). Subjects were queried regarding any AEs, SAEs, and reoperations of the index foot/ankle. Any AE resulting in reoperation or revision was recorded as an SAE. All reoperations were documented using the Surgical Reoperation Form.
|
|
Musculoskeletal and connective tissue disorders
Increased pain and swelling (Left ankle)
|
0.70%
1/142 • Number of events 1 • Adverse event data were collected from the immediate postoperative period through the 6-week, 3-month, 6-month, 1 year, and 2-year follow-ups.
Adverse events (AEs) and serious adverse events (SAEs) were assessed during the immediate postoperative period and at scheduled follow-up visits (6 weeks, 3 months, 6 months, 1 year, and 2 years). Subjects were queried regarding any AEs, SAEs, and reoperations of the index foot/ankle. Any AE resulting in reoperation or revision was recorded as an SAE. All reoperations were documented using the Surgical Reoperation Form.
|
0.00%
0/6 • Adverse event data were collected from the immediate postoperative period through the 6-week, 3-month, 6-month, 1 year, and 2-year follow-ups.
Adverse events (AEs) and serious adverse events (SAEs) were assessed during the immediate postoperative period and at scheduled follow-up visits (6 weeks, 3 months, 6 months, 1 year, and 2 years). Subjects were queried regarding any AEs, SAEs, and reoperations of the index foot/ankle. Any AE resulting in reoperation or revision was recorded as an SAE. All reoperations were documented using the Surgical Reoperation Form.
|
|
Musculoskeletal and connective tissue disorders
Right ankle pain
|
2.1%
3/142 • Number of events 6 • Adverse event data were collected from the immediate postoperative period through the 6-week, 3-month, 6-month, 1 year, and 2-year follow-ups.
Adverse events (AEs) and serious adverse events (SAEs) were assessed during the immediate postoperative period and at scheduled follow-up visits (6 weeks, 3 months, 6 months, 1 year, and 2 years). Subjects were queried regarding any AEs, SAEs, and reoperations of the index foot/ankle. Any AE resulting in reoperation or revision was recorded as an SAE. All reoperations were documented using the Surgical Reoperation Form.
|
0.00%
0/6 • Adverse event data were collected from the immediate postoperative period through the 6-week, 3-month, 6-month, 1 year, and 2-year follow-ups.
Adverse events (AEs) and serious adverse events (SAEs) were assessed during the immediate postoperative period and at scheduled follow-up visits (6 weeks, 3 months, 6 months, 1 year, and 2 years). Subjects were queried regarding any AEs, SAEs, and reoperations of the index foot/ankle. Any AE resulting in reoperation or revision was recorded as an SAE. All reoperations were documented using the Surgical Reoperation Form.
|
Additional Information
Annette Tieu, Clinical Research Specialist
Zimmer Biomet
Phone: 971-482-9622
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60