Trial Outcomes & Findings for Multi-Center Comparative Trial of the ASR™-XL Acetabular Cup System vs. the Pinnacle™ Metal- on- Metal Total Hip System (NCT NCT00561600)
NCT ID: NCT00561600
Last Updated: 2017-08-09
Results Overview
"Composite success: 1) Revision free (life of study) 2) No evidence of radiographic failure (life of study) 3) Harris Hip score =\> 80 at 24 months"
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
265 participants
Primary outcome timeframe
24-month interval.
Results posted on
2017-08-09
Participant Flow
Recruitment at orthopaedic clinics began Nov 2006 and ended Dec 2009
Participant milestones
| Measure |
A ASR™-XL
ASR™-XL Modular Acetabular Cup System stem
|
B Pinnacle™
Pinnacle™ acetabular shell, with a 28mm or 36mm ULTAMET® metal liner, and a 28mm or 36mm Articul/eze M head.
|
|---|---|---|
|
Overall Study
STARTED
|
130
|
135
|
|
Overall Study
COMPLETED
|
112
|
119
|
|
Overall Study
NOT COMPLETED
|
18
|
16
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Multi-Center Comparative Trial of the ASR™-XL Acetabular Cup System vs. the Pinnacle™ Metal- on- Metal Total Hip System
Baseline characteristics by cohort
| Measure |
ASR XL
n=130 Participants
ASR™-XL Acetabular Cup System
|
Pinnacle MoM
n=135 Participants
Pinnacle metal on metal acetabular cup system
|
Total
n=265 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59.7 years
STANDARD_DEVIATION 8.6 • n=5 Participants
|
59.4 years
STANDARD_DEVIATION 9.4 • n=7 Participants
|
59.6 years
STANDARD_DEVIATION 9.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
60 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
111 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
70 Participants
n=5 Participants
|
84 Participants
n=7 Participants
|
154 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
130 participants
n=5 Participants
|
135 participants
n=7 Participants
|
265 participants
n=5 Participants
|
|
BMI
|
29.7 lb/in^2
STANDARD_DEVIATION 7.0 • n=5 Participants
|
30.1 lb/in^2
STANDARD_DEVIATION 6.0 • n=7 Participants
|
29.9 lb/in^2
STANDARD_DEVIATION 6.5 • n=5 Participants
|
PRIMARY outcome
Timeframe: 24-month interval.Population: Out of the 265 enrolled subjects, 51 subjects were removed from the analysis for the following reasons: 2 deaths (1 inv, 1 control); 4 protocol violations (0 inv, 4 control); 6 consent withdrawn (2 inv, 4 control); 39 lost to follow-up (17 inv, 22 control).
"Composite success: 1) Revision free (life of study) 2) No evidence of radiographic failure (life of study) 3) Harris Hip score =\> 80 at 24 months"
Outcome measures
| Measure |
ASR XL Acetabular Cup System
n=110 Participants
|
Pinnacle Acetabular Cup System
n=104 Participants
|
|---|---|---|
|
Composite Success Based Upon Harris Hip Score, Radiographic and Survivorship Outcomes
|
82 participants
|
92 participants
|
SECONDARY outcome
Timeframe: 24 monthsT-Test of Harris Hip total score means at 24 months
Outcome measures
| Measure |
ASR XL Acetabular Cup System
n=110 Participants
|
Pinnacle Acetabular Cup System
n=105 Participants
|
|---|---|---|
|
T-Test of Harris Hip Total Score Means at 24 Months
|
94.8 Units on a scale of 0-100,100 is best.
Standard Deviation 9.4
|
96.4 Units on a scale of 0-100,100 is best.
Standard Deviation 6.4
|
SECONDARY outcome
Timeframe: 24 monthsMean Harris Hip Pain sub score
Outcome measures
| Measure |
ASR XL Acetabular Cup System
n=110 Participants
|
Pinnacle Acetabular Cup System
n=106 Participants
|
|---|---|---|
|
Harris Hip Pain Sub Score at 24 Months
|
41.5 units on scale of 0-44. 44 is best
Standard Deviation 6.0
|
42.7 units on scale of 0-44. 44 is best
Standard Deviation 3.3
|
SECONDARY outcome
Timeframe: 24 monthsMean Harris Hip Function sub score at 24 months
Outcome measures
| Measure |
ASR XL Acetabular Cup System
n=110 Participants
|
Pinnacle Acetabular Cup System
n=105 Participants
|
|---|---|---|
|
Harris Hip Function Score at 24 Months
|
31.4 units on a scale 0-47. 47 is best
Standard Deviation 3.6
|
31.6 units on a scale 0-47. 47 is best
Standard Deviation 3.7
|
SECONDARY outcome
Timeframe: Pre-operativePopulation: Metal ion sub-study was limited to two sites. All participants with available data are presented below.
Serum Cobalt
Outcome measures
| Measure |
ASR XL Acetabular Cup System
n=31 Participants
|
Pinnacle Acetabular Cup System
n=32 Participants
|
|---|---|---|
|
Analysis of Metal Ion Release - Serum Cobalt
|
0.10 ug/L
Interval 0.07 to 0.18
|
0.10 ug/L
Interval 0.06 to 0.4
|
SECONDARY outcome
Timeframe: pre-operativePopulation: Metal ion sub-study was limited to two sites. All participants with available data are presented below.
Serum Chromium
Outcome measures
| Measure |
ASR XL Acetabular Cup System
n=31 Participants
|
Pinnacle Acetabular Cup System
n=32 Participants
|
|---|---|---|
|
Analysis of Metal Ion Release - Serum Chromium
|
0.12 ug/L
Interval 0.07 to 1.3
|
0.12 ug/L
Interval 0.07 to 2.73
|
SECONDARY outcome
Timeframe: pre-operativePopulation: Metal ion sub-study was limited to two sites. All participants with available data are presented below.
Erythrocyte cobalt
Outcome measures
| Measure |
ASR XL Acetabular Cup System
n=31 Participants
|
Pinnacle Acetabular Cup System
n=32 Participants
|
|---|---|---|
|
Analysis of Metal Ion Release - Erythrocyte Cobalt
|
0.07 ug/L
Interval 0.05 to 1.26
|
0.08 ug/L
Interval 0.04 to 0.2
|
SECONDARY outcome
Timeframe: Pre-operativePopulation: Metal ion sub-study was limited to two sites. All participants with available data are presented below.
Erythrocyte Chromium
Outcome measures
| Measure |
ASR XL Acetabular Cup System
n=31 Participants
|
Pinnacle Acetabular Cup System
n=32 Participants
|
|---|---|---|
|
Analysis of Metal Ion Release - Erythrocyte Chromium
|
0.55 ug/L
Interval 0.2 to 59.45
|
0.62 ug/L
Interval 0.15 to 2.23
|
SECONDARY outcome
Timeframe: 4 months post-operativePopulation: Metal ion sub-study was limited to two sites. All participants with available data are presented below.
Serum Cobalt
Outcome measures
| Measure |
ASR XL Acetabular Cup System
n=32 Participants
|
Pinnacle Acetabular Cup System
n=29 Participants
|
|---|---|---|
|
Analysis of Metal Ion Release - Serum Cobalt
|
1.39 ug/L
Interval 0.06 to 10.52
|
0.51 ug/L
Interval 0.22 to 2.14
|
SECONDARY outcome
Timeframe: 4 months post operativePopulation: Metal ion sub-study was limited to two sites. All participants with available data are presented below.
Serum Chromium
Outcome measures
| Measure |
ASR XL Acetabular Cup System
n=32 Participants
|
Pinnacle Acetabular Cup System
n=29 Participants
|
|---|---|---|
|
Analysis of Metal Ion Release - Serum Chromium
|
1.38 ug/L
Interval 0.17 to 7.67
|
0.72 ug/L
Interval 0.25 to 2.48
|
SECONDARY outcome
Timeframe: 4 months post-operativePopulation: Metal ion sub-study was limited to two sites. All participants with available data are presented below.
Erythrocyte Cobalt
Outcome measures
| Measure |
ASR XL Acetabular Cup System
n=32 Participants
|
Pinnacle Acetabular Cup System
n=28 Participants
|
|---|---|---|
|
Analysis of Metal Ion Release - Erythrocyte Cobalt
|
0.85 ug/L
Interval 0.06 to 8.41
|
0.26 ug/L
Interval 0.17 to 0.92
|
SECONDARY outcome
Timeframe: 4 months post-operativePopulation: Metal ion sub-study was limited to two sites. All participants with available data are presented below.
Erythrocyte Chromium
Outcome measures
| Measure |
ASR XL Acetabular Cup System
n=32 Participants
|
Pinnacle Acetabular Cup System
n=28 Participants
|
|---|---|---|
|
Analysis of Metal Ion Release - Erythrocyte Chromium
|
0.45 ug/L
Interval 0.24 to 11.53
|
0.50 ug/L
Interval 0.15 to 2.59
|
SECONDARY outcome
Timeframe: 12 months post-operativePopulation: Metal ion sub-study was limited to two sites. All participants with available data are presented below.
Serum Cobalt
Outcome measures
| Measure |
ASR XL Acetabular Cup System
n=30 Participants
|
Pinnacle Acetabular Cup System
n=30 Participants
|
|---|---|---|
|
Analysis of Metal Ion Release - Serum Cobalt
|
1.55 ug/L
Interval 0.35 to 25.38
|
0.98 ug/L
Interval 0.17 to 5.97
|
SECONDARY outcome
Timeframe: 12 MonthsPopulation: Metal ion sub-study was limited to two sites. All participants with available data are presented below.
Serum Chromium
Outcome measures
| Measure |
ASR XL Acetabular Cup System
n=30 Participants
|
Pinnacle Acetabular Cup System
n=30 Participants
|
|---|---|---|
|
Analysis of Metal Ion Release - Serum Chromium
|
1.37 ug/L
Interval 0.29 to 28.62
|
1.19 ug/L
Interval 0.39 to 7.19
|
SECONDARY outcome
Timeframe: 12 MonthsPopulation: Metal ion sub-study was limited to two sites. All participants with available data are presented below.
Erythrocyte Cobalt
Outcome measures
| Measure |
ASR XL Acetabular Cup System
n=30 Participants
|
Pinnacle Acetabular Cup System
n=30 Participants
|
|---|---|---|
|
Analysis of Metal Ion Release - Erythrocyte Cobalt
|
0.91 ug/L
Interval 0.26 to 29.6
|
0.41 ug/L
Interval 0.14 to 3.56
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Metal ion sub-study was limited to two sites. All participants with available data are presented below.
Erythrocyte Chromium
Outcome measures
| Measure |
ASR XL Acetabular Cup System
n=30 Participants
|
Pinnacle Acetabular Cup System
n=30 Participants
|
|---|---|---|
|
Analysis of Metal Ion Release - Erythrocyte Chromium
|
1.12 ug/L
Interval 0.35 to 22.83
|
0.58 ug/L
Interval 0.2 to 4.8
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: Metal ion sub-study was limited to two sites. All participants with available data are presented below.
Serum Cobalt
Outcome measures
| Measure |
ASR XL Acetabular Cup System
n=25 Participants
|
Pinnacle Acetabular Cup System
n=21 Participants
|
|---|---|---|
|
Analysis of Metal Ion Release - Serum Cobalt
|
3.26 ug/L
Interval 0.36 to 29.14
|
1.15 ug/L
Interval 0.22 to 9.39
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: Metal ion sub-study was limited to two sites. All participants with available data are presented below.
Serum Chromium
Outcome measures
| Measure |
ASR XL Acetabular Cup System
n=25 Participants
|
Pinnacle Acetabular Cup System
n=21 Participants
|
|---|---|---|
|
Analysis of Metal Ion Release - Serum Chromium
|
2.30 ug/L
Interval 0.32 to 26.67
|
1.48 ug/L
Interval 0.62 to 7.01
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: Metal ion sub-study was limited to two sites. All participants with available data are presented below.
Erythrocyte Cobalt
Outcome measures
| Measure |
ASR XL Acetabular Cup System
n=25 Participants
|
Pinnacle Acetabular Cup System
n=21 Participants
|
|---|---|---|
|
Analysis of Metal Ion Release - Erythrocyte Cobalt
|
1.61 ug/L
Interval 0.25 to 37.55
|
0.63 ug/L
Interval 0.2 to 2.7
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: Metal ion sub-study was limited to two sites. All participants with available data are presented below.
Erythrocyte Chromium
Outcome measures
| Measure |
ASR XL Acetabular Cup System
n=25 Participants
|
Pinnacle Acetabular Cup System
n=21 Participants
|
|---|---|---|
|
Analysis of Metal Ion Release - Erythrocyte Chromium
|
1.29 ug/L
Interval 0.24 to 7.9
|
1.00 ug/L
Interval 0.2 to 3.61
|
SECONDARY outcome
Timeframe: 36 monthsPopulation: Metal ion sub-study was limited to two sites. All participants with available data are presented below.
Serum Cobalt
Outcome measures
| Measure |
ASR XL Acetabular Cup System
n=30 Participants
|
Pinnacle Acetabular Cup System
n=19 Participants
|
|---|---|---|
|
Analysis of Metal Ion Release - Serum Cobalt
|
3.17 ug/L
Interval 0.77 to 33.85
|
2.19 ug/L
Interval 0.36 to 12.63
|
SECONDARY outcome
Timeframe: 36 monthsPopulation: Metal ion sub-study was limited to two sites. All participants with available data are presented below.
Serum Chromium
Outcome measures
| Measure |
ASR XL Acetabular Cup System
n=30 Participants
|
Pinnacle Acetabular Cup System
n=19 Participants
|
|---|---|---|
|
Analysis of Metal Ion Release - Serum Chromium
|
1.80 ug/L
Interval 0.59 to 26.77
|
1.57 ug/L
Interval 0.27 to 8.73
|
SECONDARY outcome
Timeframe: 36 monthsPopulation: Metal ion sub-study was limited to two sites. All participants with available data are presented below.
Erythrocyte cobalt
Outcome measures
| Measure |
ASR XL Acetabular Cup System
n=30 Participants
|
Pinnacle Acetabular Cup System
n=19 Participants
|
|---|---|---|
|
Analysis of Metal Ion Release - Erythrocyte Cobalt
|
2.06 ug/L
Interval 0.47 to 54.65
|
1.20 ug/L
Interval 0.26 to 4.74
|
SECONDARY outcome
Timeframe: 36 monthsPopulation: Metal ion sub-study was limited to two sites. All participants with available data are presented below.
Erythrocyte chromium
Outcome measures
| Measure |
ASR XL Acetabular Cup System
n=30 Participants
|
Pinnacle Acetabular Cup System
n=19 Participants
|
|---|---|---|
|
Analysis of Metal Ion Release - Erythrocyte Chromium
|
0.76 ug/L
Interval 0.18 to 7.82
|
0.73 ug/L
Interval 0.22 to 3.85
|
SECONDARY outcome
Timeframe: 48 monthsPopulation: Metal ion sub-study was limited to two sites. All participants with available data are presented below.
Serum Cobalt
Outcome measures
| Measure |
ASR XL Acetabular Cup System
n=15 Participants
|
Pinnacle Acetabular Cup System
n=13 Participants
|
|---|---|---|
|
Analysis of Metal Ion Release - Serum Cobalt
|
3.16 ug/L
Interval 0.66 to 33.78
|
1.83 ug/L
Interval 0.46 to 7.37
|
SECONDARY outcome
Timeframe: 48 monthsPopulation: Metal ion sub-study was limited to two sites. All participants with available data are presented below.
Serum Chromium
Outcome measures
| Measure |
ASR XL Acetabular Cup System
n=15 Participants
|
Pinnacle Acetabular Cup System
n=13 Participants
|
|---|---|---|
|
Analysis of Metal Ion Release - Serum Chromium
|
2.04 ug/L
Interval 0.68 to 25.25
|
1.66 ug/L
Interval 0.36 to 6.04
|
SECONDARY outcome
Timeframe: 48 monthsPopulation: Metal ion sub-study was limited to two sites. All participants with available data are presented below.
Erythrocyte Cobalt
Outcome measures
| Measure |
ASR XL Acetabular Cup System
n=13 Participants
|
Pinnacle Acetabular Cup System
n=12 Participants
|
|---|---|---|
|
Analysis of Metal Ion Release - Erythrocyte Cobalt
|
1.90 ug/L
Interval 0.58 to 40.89
|
1.18 ug/L
Interval 0.2 to 3.45
|
SECONDARY outcome
Timeframe: 48 monthsPopulation: Metal ion sub-study was limited to two sites. All participants with available data are presented below.
Erythrocyte chromium
Outcome measures
| Measure |
ASR XL Acetabular Cup System
n=13 Participants
|
Pinnacle Acetabular Cup System
n=12 Participants
|
|---|---|---|
|
Analysis of Metal Ion Release - Erythrocyte Chromium
|
0.62 ug/L
Interval 0.21 to 4.21
|
0.62 ug/L
Interval 0.33 to 1.25
|
Adverse Events
ASR XL Acetabular Cup System
Serious events: 0 serious events
Other events: 72 other events
Deaths: 0 deaths
Pinnacle Acetabular Cup System
Serious events: 0 serious events
Other events: 59 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
ASR XL Acetabular Cup System
n=130 participants at risk
|
Pinnacle Acetabular Cup System
n=135 participants at risk
|
|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
0.77%
1/130 • Number of events 1 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
2.2%
3/135 • Number of events 3 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
|
Cardiac disorders
Atrial flutter
|
0.77%
1/130 • Number of events 1 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
0.00%
0/135 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/130 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
0.74%
1/135 • Number of events 1 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
|
Cardiac disorders
Coronary artery occlusion
|
0.00%
0/130 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
0.74%
1/135 • Number of events 1 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
|
Cardiac disorders
Myocardial infarction
|
1.5%
2/130 • Number of events 2 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
0.74%
1/135 • Number of events 1 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
|
Cardiac disorders
Sinus tachycardia
|
0.77%
1/130 • Number of events 1 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
0.00%
0/135 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/130 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
0.74%
1/135 • Number of events 1 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
|
Congenital, familial and genetic disorders
Hip dysplasia
|
0.00%
0/130 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
0.74%
1/135 • Number of events 1 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/130 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
0.74%
1/135 • Number of events 1 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
|
Gastrointestinal disorders
Colitis
|
0.77%
1/130 • Number of events 1 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
0.00%
0/135 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/130 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
0.74%
1/135 • Number of events 1 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.77%
1/130 • Number of events 2 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
0.74%
1/135 • Number of events 1 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
|
General disorders
Asthenia
|
0.00%
0/130 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
0.74%
1/135 • Number of events 1 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
|
General disorders
Death
|
0.77%
1/130 • Number of events 1 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
0.00%
0/135 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
|
General disorders
Device component issue
|
4.6%
6/130 • Number of events 7 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
0.00%
0/135 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
|
General disorders
Device dislocation
|
0.00%
0/130 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
0.74%
1/135 • Number of events 1 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
|
General disorders
Medical device complication
|
0.00%
0/130 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
0.74%
1/135 • Number of events 1 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
|
General disorders
Medical device site reaction
|
3.8%
5/130 • Number of events 5 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
0.74%
1/135 • Number of events 1 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
|
General disorders
Pain
|
3.1%
4/130 • Number of events 4 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
1.5%
2/135 • Number of events 2 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/130 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
0.74%
1/135 • Number of events 1 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
|
Immune system disorders
Multiple sclerosis
|
0.77%
1/130 • Number of events 1 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
0.00%
0/135 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
|
Infections and infestations
Abscess
|
0.00%
0/130 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
0.74%
1/135 • Number of events 1 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
|
Infections and infestations
Cellulitis
|
0.77%
1/130 • Number of events 1 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
0.74%
1/135 • Number of events 2 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
|
Infections and infestations
Infection
|
0.77%
1/130 • Number of events 1 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
2.2%
3/135 • Number of events 5 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
|
Infections and infestations
Laryngitis
|
0.00%
0/130 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
0.74%
1/135 • Number of events 1 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
|
Infections and infestations
Oral candidacies
|
0.77%
1/130 • Number of events 1 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
0.00%
0/135 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
|
Infections and infestations
Pneumonia
|
0.77%
1/130 • Number of events 1 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
0.00%
0/135 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/130 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
0.74%
1/135 • Number of events 1 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
|
Infections and infestations
Urinary tract infection
|
0.77%
1/130 • Number of events 1 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
0.74%
1/135 • Number of events 1 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
|
Injury, poisoning and procedural complications
Fracture
|
2.3%
3/130 • Number of events 4 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
0.74%
1/135 • Number of events 1 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
|
Injury, poisoning and procedural complications
Gun shot wound
|
0.00%
0/130 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
0.74%
1/135 • Number of events 1 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
|
Injury, poisoning and procedural complications
Iliotibial band syndrome
|
1.5%
2/130 • Number of events 3 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
1.5%
2/135 • Number of events 2 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/130 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
2.2%
3/135 • Number of events 3 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.77%
1/130 • Number of events 2 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
0.00%
0/135 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
1.5%
2/130 • Number of events 2 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
0.00%
0/135 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.77%
1/130 • Number of events 1 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
1.5%
2/135 • Number of events 2 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
|
Injury, poisoning and procedural complications
Postoperative heterotopic calcification
|
0.00%
0/130 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
0.74%
1/135 • Number of events 1 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.77%
1/130 • Number of events 1 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
0.00%
0/135 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.77%
1/130 • Number of events 1 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
0.00%
0/135 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
|
Injury, poisoning and procedural complications
Wound complication
|
1.5%
2/130 • Number of events 3 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
3.0%
4/135 • Number of events 5 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
|
Investigations
Blood heavy metal increased
|
3.1%
4/130 • Number of events 4 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
0.00%
0/135 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
|
Investigations
Hematocrit decreased
|
0.00%
0/130 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
0.74%
1/135 • Number of events 1 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
|
Investigations
White blood cell increased
|
0.00%
0/130 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
0.74%
1/135 • Number of events 1 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/130 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
0.74%
1/135 • Number of events 2 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.77%
1/130 • Number of events 1 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
0.00%
0/135 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.9%
9/130 • Number of events 20 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
8.1%
11/135 • Number of events 15 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia joint swelling
|
0.77%
1/130 • Number of events 1 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
0.00%
0/135 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.77%
1/130 • Number of events 1 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
0.74%
1/135 • Number of events 1 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
|
Musculoskeletal and connective tissue disorders
Back disorder
|
0.00%
0/130 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
0.74%
1/135 • Number of events 1 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.8%
5/130 • Number of events 5 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
4.4%
6/135 • Number of events 6 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
|
Musculoskeletal and connective tissue disorders
Bone loss
|
0.77%
1/130 • Number of events 1 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
0.00%
0/135 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
9.2%
12/130 • Number of events 19 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
5.9%
8/135 • Number of events 10 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
3.8%
5/130 • Number of events 6 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
2.2%
3/135 • Number of events 5 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.77%
1/130 • Number of events 1 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
0.00%
0/135 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
|
Musculoskeletal and connective tissue disorders
Joint crepitation
|
0.00%
0/130 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
0.74%
1/135 • Number of events 1 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
|
Musculoskeletal and connective tissue disorders
Joint lock
|
0.77%
1/130 • Number of events 1 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
0.00%
0/135 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.77%
1/130 • Number of events 1 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
0.00%
0/135 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
|
Musculoskeletal and connective tissue disorders
Muscle disorder
|
0.00%
0/130 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
0.74%
1/135 • Number of events 1 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/130 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
0.74%
1/135 • Number of events 1 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
0.77%
1/130 • Number of events 1 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
0.00%
0/135 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.77%
1/130 • Number of events 1 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
0.74%
1/135 • Number of events 1 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.3%
3/130 • Number of events 3 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
0.00%
0/135 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.00%
0/130 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
0.74%
1/135 • Number of events 1 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
6.2%
8/130 • Number of events 11 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
5.2%
7/135 • Number of events 9 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.5%
2/130 • Number of events 3 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
0.74%
1/135 • Number of events 1 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.77%
1/130 • Number of events 1 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
0.00%
0/135 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
|
Musculoskeletal and connective tissue disorders
Plantar Fascitis
|
0.00%
0/130 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
0.74%
1/135 • Number of events 1 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.77%
1/130 • Number of events 1 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
0.00%
0/135 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
|
Musculoskeletal and connective tissue disorders
Rotataor cuff syndrome
|
0.77%
1/130 • Number of events 1 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
0.00%
0/135 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.77%
1/130 • Number of events 1 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
0.00%
0/135 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
0.77%
1/130 • Number of events 2 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
0.00%
0/135 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
1.5%
2/130 • Number of events 2 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
1.5%
2/135 • Number of events 2 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/130 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
1.5%
2/135 • Number of events 2 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/130 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
1.5%
2/135 • Number of events 2 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer metastatic
|
0.77%
1/130 • Number of events 2 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
0.00%
0/135 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm malignant
|
0.77%
1/130 • Number of events 1 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
0.00%
0/135 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.77%
1/130 • Number of events 1 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
0.74%
1/135 • Number of events 1 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.00%
0/130 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
0.74%
1/135 • Number of events 1 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
|
Nervous system disorders
Paresthesia
|
0.00%
0/130 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
1.5%
2/135 • Number of events 2 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
|
Nervous system disorders
Piriformis syndrome
|
0.77%
1/130 • Number of events 1 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
0.00%
0/135 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
|
Nervous system disorders
Sciatica
|
1.5%
2/130 • Number of events 2 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
0.00%
0/135 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
|
Psychiatric disorders
Anxiety
|
0.77%
1/130 • Number of events 1 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
0.00%
0/135 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
|
Renal and urinary disorders
Renal failure acute
|
0.77%
1/130 • Number of events 1 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
0.00%
0/135 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
|
Respiratory, thoracic and mediastinal disorders
Chest discomfort
|
0.00%
0/130 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
0.74%
1/135 • Number of events 1 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/130 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
0.74%
1/135 • Number of events 1 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
0.00%
0/130 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
0.74%
1/135 • Number of events 2 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.77%
1/130 • Number of events 1 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
0.00%
0/135 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.5%
2/130 • Number of events 2 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
0.00%
0/135 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
|
Surgical and medical procedures
Angioplasty
|
0.77%
1/130 • Number of events 1 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
0.74%
1/135 • Number of events 1 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
|
Surgical and medical procedures
Hip arthroplasty
|
3.8%
5/130 • Number of events 6 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
2.2%
3/135 • Number of events 3 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
|
Surgical and medical procedures
Knee arthroplasty
|
1.5%
2/130 • Number of events 3 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
0.74%
1/135 • Number of events 1 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
|
Surgical and medical procedures
Knee operation
|
0.00%
0/130 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
0.74%
1/135 • Number of events 1 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
|
Surgical and medical procedures
Post procedural drainage
|
0.00%
0/130 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
0.74%
1/135 • Number of events 1 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
|
Surgical and medical procedures
Shoulder operation
|
0.77%
1/130 • Number of events 1 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
0.00%
0/135 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
|
Vascular disorders
Aortic aneurysm
|
0.00%
0/130 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
0.74%
1/135 • Number of events 1 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
|
Vascular disorders
Haematoma
|
0.77%
1/130 • Number of events 1 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
0.00%
0/135 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
|
Vascular disorders
Hypertension
|
0.00%
0/130 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
0.74%
1/135 • Number of events 1 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
|
Vascular disorders
Hypotension
|
1.5%
2/130 • Number of events 2 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
0.00%
0/135 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
|
Vascular disorders
Varicose vein
|
0.00%
0/130 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
0.74%
1/135 • Number of events 1 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
|
Injury, poisoning and procedural complications
Epicondylitis
|
0.77%
1/130 • Number of events 1 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
0.00%
0/135 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
|
General disorders
Adverse drug reaction
|
0.77%
1/130 • Number of events 1 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
0.00%
0/135 • AE data were collected at 1 month, 4 months, 12 months, 24 months, and annually until study closure. Longest post operative interval with AE data was 60 months.
|
Additional Information
Dave Whalen Clinical Portfolio Leader
DePuy Orthopaedics
Phone: 574-372-7028
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60