Trial Outcomes & Findings for Scorpio NRG (eNeRGize) Cruciate Retaining (CR) Post-market International Outcome Study (NCT NCT02524730)
NCT ID: NCT02524730
Last Updated: 2024-02-22
Results Overview
Assess survival (absence of revision) at 7 year follow-up
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
205 participants
Primary outcome timeframe
7 year follow-up
Results posted on
2024-02-22
Participant Flow
205 participants who agreed to participate in the study following completion of the informed consent process were enrolled into the study
Participant milestones
| Measure |
Scorpio NRG CR Total Knee System
Primary total knee replacement
Primary total knee replacement (Scorpio NRG CR Total Knee System): Scorpio NRG CR Total Knee System
|
|---|---|
|
Overall Study
STARTED
|
205
|
|
Overall Study
COMPLETED
|
159
|
|
Overall Study
NOT COMPLETED
|
46
|
Reasons for withdrawal
| Measure |
Scorpio NRG CR Total Knee System
Primary total knee replacement
Primary total knee replacement (Scorpio NRG CR Total Knee System): Scorpio NRG CR Total Knee System
|
|---|---|
|
Overall Study
Lost to Follow-up
|
5
|
|
Overall Study
Withdrawal by Subject
|
18
|
|
Overall Study
Death
|
10
|
|
Overall Study
Adverse Event
|
8
|
|
Overall Study
Protocol Violation
|
1
|
|
Overall Study
Subjects received Scorpio NRG PS (Posterior Stabilizing)
|
4
|
Baseline Characteristics
Gender information permanently missing in one case.
Baseline characteristics by cohort
| Measure |
Scorpio NRG CR Total Knee System
n=205 Participants
Primary total knee replacement
Primary total knee replacement (Scorpio NRG CR Total Knee System): Scorpio NRG CR Total Knee System
|
|---|---|
|
Age, Continuous
|
65.53 years
STANDARD_DEVIATION 6.5 • n=205 Participants
|
|
Sex: Female, Male
Female
|
132 Participants
n=204 Participants • Gender information permanently missing in one case.
|
|
Sex: Female, Male
Male
|
72 Participants
n=204 Participants • Gender information permanently missing in one case.
|
|
Region of Enrollment
Europe
|
205 participants
n=205 Participants
|
|
Indication
Osteoarthritis
|
200 participants
n=204 Participants • Indication information permanently missing in one case.
|
|
Indication
Post-traumatic Arthritis
|
4 participants
n=204 Participants • Indication information permanently missing in one case.
|
PRIMARY outcome
Timeframe: 7 year follow-upAssess survival (absence of revision) at 7 year follow-up
Outcome measures
| Measure |
Scorpio NRG CR Total Knee System
n=197 Participants
Primary total knee replacement
Primary total knee replacement (Scorpio NRG CR Total Knee System): Scorpio NRG CR Total Knee System
|
|---|---|
|
Survival Rate
Femoral Component Revision
|
2 Participants
|
|
Survival Rate
Inlay Revision
|
1 Participants
|
|
Survival Rate
Tibial Tray Revision
|
1 Participants
|
|
Survival Rate
Total Knee Arthroplasty Revision
|
4 Participants
|
|
Survival Rate
No Revision
|
189 Participants
|
SECONDARY outcome
Timeframe: Pre-operative, 3 months, 1, 3, 5 and optional 7 yearsPopulation: Numbers analyzed represent evaluable cases
The Knee Society Clinical Rating System is comprised of two distinct sub-scores: one for pain, range of motion (ROM) and joint stability, and one for functional parameters. Sub-scores range from a potential minimum score of 0 to a maximum score of 100 points. Although the specific scores are not distinguished as "excellent," "good," "fair," or "poor," a higher value represents a better outcome.
Outcome measures
| Measure |
Scorpio NRG CR Total Knee System
n=204 Participants
Primary total knee replacement
Primary total knee replacement (Scorpio NRG CR Total Knee System): Scorpio NRG CR Total Knee System
|
|---|---|
|
Investigation of Clinical Performance and Patient Outcome With the Knee Society Score (KSS)
Pre-operative pain motion score
|
57.84 units on a scale
Standard Deviation 13.34
|
|
Investigation of Clinical Performance and Patient Outcome With the Knee Society Score (KSS)
Pain motion score at 3 months
|
78.71 units on a scale
Standard Deviation 12.36
|
|
Investigation of Clinical Performance and Patient Outcome With the Knee Society Score (KSS)
Pain motion score at 1 year
|
83.27 units on a scale
Standard Deviation 10.15
|
|
Investigation of Clinical Performance and Patient Outcome With the Knee Society Score (KSS)
Pain motion score at 3 years
|
83.85 units on a scale
Standard Deviation 11.42
|
|
Investigation of Clinical Performance and Patient Outcome With the Knee Society Score (KSS)
Pain motion score at 5 years
|
84.73 units on a scale
Standard Deviation 11.57
|
|
Investigation of Clinical Performance and Patient Outcome With the Knee Society Score (KSS)
Pain motion score at 7 years
|
84.20 units on a scale
Standard Deviation 10.33
|
|
Investigation of Clinical Performance and Patient Outcome With the Knee Society Score (KSS)
Pre-operative function score
|
61.54 units on a scale
Standard Deviation 17.78
|
|
Investigation of Clinical Performance and Patient Outcome With the Knee Society Score (KSS)
Function score at 3 months
|
78.05 units on a scale
Standard Deviation 16.95
|
|
Investigation of Clinical Performance and Patient Outcome With the Knee Society Score (KSS)
Function score at 1 year
|
87.99 units on a scale
Standard Deviation 15.68
|
|
Investigation of Clinical Performance and Patient Outcome With the Knee Society Score (KSS)
Function score at 3 years
|
85.00 units on a scale
Standard Deviation 19.34
|
|
Investigation of Clinical Performance and Patient Outcome With the Knee Society Score (KSS)
Function score at 5 years
|
83.75 units on a scale
Standard Deviation 19.75
|
|
Investigation of Clinical Performance and Patient Outcome With the Knee Society Score (KSS)
Function score at 7 years
|
83.51 units on a scale
Standard Deviation 21.43
|
SECONDARY outcome
Timeframe: Pre-operative, 3 months,1, 3, 5 and optional 7 yearsPopulation: Numbers analyzed represent evaluable cases.
The LEAS is completed by the participant to assess activity level. Activity levels were ordered in terms of intensity from 1 to 18, with 18 indicating the highest activity level.
Outcome measures
| Measure |
Scorpio NRG CR Total Knee System
n=205 Participants
Primary total knee replacement
Primary total knee replacement (Scorpio NRG CR Total Knee System): Scorpio NRG CR Total Knee System
|
|---|---|
|
Investigation of Clinical Performance and Patient Outcome With the Lower Extremity Activity Scale (LEAS) Patient Questionnaire
pre-operative activity level
|
8.61 units on a scale
Standard Deviation 2.51
|
|
Investigation of Clinical Performance and Patient Outcome With the Lower Extremity Activity Scale (LEAS) Patient Questionnaire
Activity level at 3 months
|
9.43 units on a scale
Standard Deviation 2.81
|
|
Investigation of Clinical Performance and Patient Outcome With the Lower Extremity Activity Scale (LEAS) Patient Questionnaire
Activity level at 1 year
|
11.11 units on a scale
Standard Deviation 3.06
|
|
Investigation of Clinical Performance and Patient Outcome With the Lower Extremity Activity Scale (LEAS) Patient Questionnaire
Activity level at 3 years
|
10.68 units on a scale
Standard Deviation 3.00
|
|
Investigation of Clinical Performance and Patient Outcome With the Lower Extremity Activity Scale (LEAS) Patient Questionnaire
Activity level at 5 years
|
10.38 units on a scale
Standard Deviation 3.09
|
|
Investigation of Clinical Performance and Patient Outcome With the Lower Extremity Activity Scale (LEAS) Patient Questionnaire
Activity level at 7 years
|
10.75 units on a scale
Standard Deviation 3.20
|
SECONDARY outcome
Timeframe: Pre-operative, 3 months,1, 3, 5 and optional 7 yearsPopulation: Numbers analyzed represent evaluable cases.
The SF-36 is a 36-item patient completed questionnaire to measure general health and well-being. It includes physical and mental status component sub scores (physical function, physical role functioning, body pain, general health, vitality, social functioning, emotional role, mental health); each ranging from 0-100. Low values represent a poor health state and high values represent a good health state.
Outcome measures
| Measure |
Scorpio NRG CR Total Knee System
n=205 Participants
Primary total knee replacement
Primary total knee replacement (Scorpio NRG CR Total Knee System): Scorpio NRG CR Total Knee System
|
|---|---|
|
Investigation of Clinical Performance and Patient Outcome With the Short Form - 36 Health Survey (SF-36)
Pre-operative physical function
|
30.62 units on a scale
Standard Deviation 7.91
|
|
Investigation of Clinical Performance and Patient Outcome With the Short Form - 36 Health Survey (SF-36)
Physical function at 3 months
|
40.2 units on a scale
Standard Deviation 8.86
|
|
Investigation of Clinical Performance and Patient Outcome With the Short Form - 36 Health Survey (SF-36)
Physical function at 1 year
|
44.67 units on a scale
Standard Deviation 8.6
|
|
Investigation of Clinical Performance and Patient Outcome With the Short Form - 36 Health Survey (SF-36)
Physical function at 3 years
|
43.97 units on a scale
Standard Deviation 9.8
|
|
Investigation of Clinical Performance and Patient Outcome With the Short Form - 36 Health Survey (SF-36)
Physical function at 5 years
|
42.41 units on a scale
Standard Deviation 10.8
|
|
Investigation of Clinical Performance and Patient Outcome With the Short Form - 36 Health Survey (SF-36)
Physical function at 7 years
|
43.07 units on a scale
Standard Deviation 10.71
|
|
Investigation of Clinical Performance and Patient Outcome With the Short Form - 36 Health Survey (SF-36)
Pre-operative physical role functioning
|
34.48 units on a scale
Standard Deviation 9.19
|
|
Investigation of Clinical Performance and Patient Outcome With the Short Form - 36 Health Survey (SF-36)
Physical role functioning at 3 months
|
39.04 units on a scale
Standard Deviation 9.34
|
|
Investigation of Clinical Performance and Patient Outcome With the Short Form - 36 Health Survey (SF-36)
Physical role functioning at 1 year
|
45.11 units on a scale
Standard Deviation 9.77
|
|
Investigation of Clinical Performance and Patient Outcome With the Short Form - 36 Health Survey (SF-36)
Physical role functioning at 3 years
|
44.0 units on a scale
Standard Deviation 9.77
|
|
Investigation of Clinical Performance and Patient Outcome With the Short Form - 36 Health Survey (SF-36)
Physical role functioning at 5 years
|
43.26 units on a scale
Standard Deviation 10.75
|
|
Investigation of Clinical Performance and Patient Outcome With the Short Form - 36 Health Survey (SF-36)
Physical role functioning at 7 years
|
43.65 units on a scale
Standard Deviation 10.56
|
|
Investigation of Clinical Performance and Patient Outcome With the Short Form - 36 Health Survey (SF-36)
Pre-operative body pain
|
42.24 units on a scale
Standard Deviation 3.23
|
|
Investigation of Clinical Performance and Patient Outcome With the Short Form - 36 Health Survey (SF-36)
Body pain at 3 months
|
40.69 units on a scale
Standard Deviation 3.52
|
|
Investigation of Clinical Performance and Patient Outcome With the Short Form - 36 Health Survey (SF-36)
Body pain at 1 year
|
39.72 units on a scale
Standard Deviation 3.28
|
|
Investigation of Clinical Performance and Patient Outcome With the Short Form - 36 Health Survey (SF-36)
Body pain at 3 years
|
39.47 units on a scale
Standard Deviation 3.17
|
|
Investigation of Clinical Performance and Patient Outcome With the Short Form - 36 Health Survey (SF-36)
Body pain at 5 years
|
39.48 units on a scale
Standard Deviation 3.74
|
|
Investigation of Clinical Performance and Patient Outcome With the Short Form - 36 Health Survey (SF-36)
Body pain at 7 years
|
39.35 units on a scale
Standard Deviation 3.3
|
|
Investigation of Clinical Performance and Patient Outcome With the Short Form - 36 Health Survey (SF-36)
Pre-operative general health
|
49.2 units on a scale
Standard Deviation 8.15
|
|
Investigation of Clinical Performance and Patient Outcome With the Short Form - 36 Health Survey (SF-36)
General health at 3 months
|
51.48 units on a scale
Standard Deviation 7.57
|
|
Investigation of Clinical Performance and Patient Outcome With the Short Form - 36 Health Survey (SF-36)
General health at 1 year
|
51.6 units on a scale
Standard Deviation 8.28
|
|
Investigation of Clinical Performance and Patient Outcome With the Short Form - 36 Health Survey (SF-36)
General health at 3 years
|
49.9 units on a scale
Standard Deviation 8.38
|
|
Investigation of Clinical Performance and Patient Outcome With the Short Form - 36 Health Survey (SF-36)
General health at 5 years
|
48.95 units on a scale
Standard Deviation 9.02
|
|
Investigation of Clinical Performance and Patient Outcome With the Short Form - 36 Health Survey (SF-36)
General health at 7 years
|
48.11 units on a scale
Standard Deviation 8.82
|
|
Investigation of Clinical Performance and Patient Outcome With the Short Form - 36 Health Survey (SF-36)
Pre-operative vitality
|
49.94 units on a scale
Standard Deviation 8.61
|
|
Investigation of Clinical Performance and Patient Outcome With the Short Form - 36 Health Survey (SF-36)
Vitality at 3 months
|
52.73 units on a scale
Standard Deviation 8.93
|
|
Investigation of Clinical Performance and Patient Outcome With the Short Form - 36 Health Survey (SF-36)
Vitality at 1 year
|
55.71 units on a scale
Standard Deviation 9.4
|
|
Investigation of Clinical Performance and Patient Outcome With the Short Form - 36 Health Survey (SF-36)
Vitality at 3 years
|
54.61 units on a scale
Standard Deviation 9.46
|
|
Investigation of Clinical Performance and Patient Outcome With the Short Form - 36 Health Survey (SF-36)
Vitality at 5 years
|
54.42 units on a scale
Standard Deviation 8.56
|
|
Investigation of Clinical Performance and Patient Outcome With the Short Form - 36 Health Survey (SF-36)
Vitality at 7 years
|
54.52 units on a scale
Standard Deviation 9.38
|
|
Investigation of Clinical Performance and Patient Outcome With the Short Form - 36 Health Survey (SF-36)
Pre-operative social functioning
|
44.67 units on a scale
Standard Deviation 10.12
|
|
Investigation of Clinical Performance and Patient Outcome With the Short Form - 36 Health Survey (SF-36)
Social functioning at 3 months
|
49.17 units on a scale
Standard Deviation 8.91
|
|
Investigation of Clinical Performance and Patient Outcome With the Short Form - 36 Health Survey (SF-36)
Social functioning at 1 year
|
51.16 units on a scale
Standard Deviation 8.54
|
|
Investigation of Clinical Performance and Patient Outcome With the Short Form - 36 Health Survey (SF-36)
Social functioning at 3 years
|
51.27 units on a scale
Standard Deviation 8.26
|
|
Investigation of Clinical Performance and Patient Outcome With the Short Form - 36 Health Survey (SF-36)
Social functioning at 5 years
|
50.83 units on a scale
Standard Deviation 7.96
|
|
Investigation of Clinical Performance and Patient Outcome With the Short Form - 36 Health Survey (SF-36)
Social functioning at 7 years
|
49.97 units on a scale
Standard Deviation 8.98
|
|
Investigation of Clinical Performance and Patient Outcome With the Short Form - 36 Health Survey (SF-36)
Pre-operative emotional role
|
43.41 units on a scale
Standard Deviation 12.92
|
|
Investigation of Clinical Performance and Patient Outcome With the Short Form - 36 Health Survey (SF-36)
Emotional role at 3 months
|
46.65 units on a scale
Standard Deviation 11.65
|
|
Investigation of Clinical Performance and Patient Outcome With the Short Form - 36 Health Survey (SF-36)
Emotional role at 1 year
|
47.81 units on a scale
Standard Deviation 11.10
|
|
Investigation of Clinical Performance and Patient Outcome With the Short Form - 36 Health Survey (SF-36)
Emotional role at 3 years
|
46.83 units on a scale
Standard Deviation 10.81
|
|
Investigation of Clinical Performance and Patient Outcome With the Short Form - 36 Health Survey (SF-36)
Emotional role at 5 years
|
47.47 units on a scale
Standard Deviation 11.4
|
|
Investigation of Clinical Performance and Patient Outcome With the Short Form - 36 Health Survey (SF-36)
Emotional role at 7 years
|
46.0 units on a scale
Standard Deviation 11.78
|
|
Investigation of Clinical Performance and Patient Outcome With the Short Form - 36 Health Survey (SF-36)
Pre-operative mental health
|
50.23 units on a scale
Standard Deviation 9.4
|
|
Investigation of Clinical Performance and Patient Outcome With the Short Form - 36 Health Survey (SF-36)
Mental health at 3 months
|
52.6 units on a scale
Standard Deviation 9.86
|
|
Investigation of Clinical Performance and Patient Outcome With the Short Form - 36 Health Survey (SF-36)
Mental health at 1 year
|
53.39 units on a scale
Standard Deviation 9.96
|
|
Investigation of Clinical Performance and Patient Outcome With the Short Form - 36 Health Survey (SF-36)
Mental health at 3 years
|
53.06 units on a scale
Standard Deviation 8.80
|
|
Investigation of Clinical Performance and Patient Outcome With the Short Form - 36 Health Survey (SF-36)
Mental health at 5 years
|
53.52 units on a scale
Standard Deviation 8.63
|
|
Investigation of Clinical Performance and Patient Outcome With the Short Form - 36 Health Survey (SF-36)
Mental health at 7 years
|
52.5 units on a scale
Standard Deviation 9.36
|
SECONDARY outcome
Timeframe: Pre-operative,1, 5 and optional 7 yearsPopulation: Numbers analyzed represent evaluable cases. The KOOS was collected pre-operatively and at 1, 5 and 7 years only.
KOOS consists of 5 subscales: Pain, other symptoms, function in daily living , function in sport and recreation and knee related quality of life (QOL). The previous week is the time period considered when answering the questions. Standardized answer options are given (5 Likert boxes) and each question is assigned a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms).
Outcome measures
| Measure |
Scorpio NRG CR Total Knee System
n=202 Participants
Primary total knee replacement
Primary total knee replacement (Scorpio NRG CR Total Knee System): Scorpio NRG CR Total Knee System
|
|---|---|
|
Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire.
Function, daily living at 5 years
|
83.47 units on a scale
Standard Deviation 18.46
|
|
Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire.
Function, daily living at 7 years
|
84.24 units on a scale
Standard Deviation 19.23
|
|
Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire.
Quality of life (QoL) pre-operative
|
24.36 units on a scale
Standard Deviation 14.86
|
|
Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire.
QoL at 1 year
|
66.19 units on a scale
Standard Deviation 24.11
|
|
Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire.
QoL at 5 years
|
66.78 units on a scale
Standard Deviation 23.41
|
|
Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire.
QoL at 7 years
|
65.54 units on a scale
Standard Deviation 21.81
|
|
Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire.
Function, daily living pre-operative
|
46.59 units on a scale
Standard Deviation 18.2
|
|
Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire.
Function, daily living at 1 year
|
82.7 units on a scale
Standard Deviation 17.35
|
|
Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire.
Symptoms pre-operative
|
49.91 units on a scale
Standard Deviation 18.55
|
|
Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire.
Symptoms at 1 year
|
79.58 units on a scale
Standard Deviation 15.73
|
|
Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire.
Symptoms at 5 years
|
83.38 units on a scale
Standard Deviation 16.1
|
|
Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire.
Symptoms at 7 years
|
85.83 units on a scale
Standard Deviation 15.46
|
|
Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire.
Pain pre-operative
|
41.28 units on a scale
Standard Deviation 17.82
|
|
Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire.
Pain at 1 year
|
82.9 units on a scale
Standard Deviation 19.14
|
|
Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire.
Pain at 5 years
|
84.36 units on a scale
Standard Deviation 19.38
|
|
Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire.
Pain at 7 years
|
86.99 units on a scale
Standard Deviation 17.74
|
|
Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire.
Function, sports and recreation activities pre-operative
|
14.15 units on a scale
Standard Deviation 16.26
|
|
Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire.
Function, sports and recreation activities at 1 year
|
47.89 units on a scale
Standard Deviation 29.08
|
|
Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire.
Function, sports and recreation activities at 5 years
|
48.71 units on a scale
Standard Deviation 31.05
|
|
Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire.
Function, sports and recreation activities at 7 years
|
52.79 units on a scale
Standard Deviation 33.45
|
SECONDARY outcome
Timeframe: Pre-operative, 3 months,1, 3, 5 and optional 7 yearsPopulation: Numbers analyzed represent evaluable cases.
The EuroQol-5 Dimension (EQ-5D) is a subject-completed questionnaire designed to assess subject health state values. The EQ-5D consists of 2 areas; EQ-5D descriptive system and the visual analogue scale (VAS). The EQ-5D descriptive system comprises the following five dimensions: mobility self care, usual activities, pain/comfort and anxiety/depression. Each dimension has 3 levels indicating no problems, some problems or extreme problems. The index values on a scale between -1 (low) and 1 (high) are showing the average health status according to the 5 dimensions: A low score shows worse health and a high score shows better health. With the EQ VAS the respondents can report their perceived health status with a grade ranging from 0 (the worst possible health status) to 100 (the best possible health status).
Outcome measures
| Measure |
Scorpio NRG CR Total Knee System
n=203 Participants
Primary total knee replacement
Primary total knee replacement (Scorpio NRG CR Total Knee System): Scorpio NRG CR Total Knee System
|
|---|---|
|
Investigation of Clinical Performance and Patient Outcome With the EuroQuol-5 Dimension Health Questionnaire (EQ-5D).
Pre-operative visual analogue scale (VAS)
|
70.97 units on a scale
Standard Deviation 16.75
|
|
Investigation of Clinical Performance and Patient Outcome With the EuroQuol-5 Dimension Health Questionnaire (EQ-5D).
VAS at 3 months
|
76.96 units on a scale
Standard Deviation 13.92
|
|
Investigation of Clinical Performance and Patient Outcome With the EuroQuol-5 Dimension Health Questionnaire (EQ-5D).
VAS at 1 year
|
77.41 units on a scale
Standard Deviation 14.40
|
|
Investigation of Clinical Performance and Patient Outcome With the EuroQuol-5 Dimension Health Questionnaire (EQ-5D).
VAS at 3 years
|
75.09 units on a scale
Standard Deviation 14.11
|
|
Investigation of Clinical Performance and Patient Outcome With the EuroQuol-5 Dimension Health Questionnaire (EQ-5D).
VAS at 5 years
|
76.84 units on a scale
Standard Deviation 13.23
|
|
Investigation of Clinical Performance and Patient Outcome With the EuroQuol-5 Dimension Health Questionnaire (EQ-5D).
VAS at 7 years
|
77.03 units on a scale
Standard Deviation 14.77
|
|
Investigation of Clinical Performance and Patient Outcome With the EuroQuol-5 Dimension Health Questionnaire (EQ-5D).
Pre-operative descriptive EQ-5D
|
0.55 units on a scale
Standard Deviation 0.26
|
|
Investigation of Clinical Performance and Patient Outcome With the EuroQuol-5 Dimension Health Questionnaire (EQ-5D).
Descriptive EQ-5D at 3 months
|
0.77 units on a scale
Standard Deviation 0.17
|
|
Investigation of Clinical Performance and Patient Outcome With the EuroQuol-5 Dimension Health Questionnaire (EQ-5D).
Descriptive EQ-5D at 1 year
|
0.84 units on a scale
Standard Deviation 0.17
|
|
Investigation of Clinical Performance and Patient Outcome With the EuroQuol-5 Dimension Health Questionnaire (EQ-5D).
Descriptive EQ-5D at 3 years
|
0.83 units on a scale
Standard Deviation 0.19
|
|
Investigation of Clinical Performance and Patient Outcome With the EuroQuol-5 Dimension Health Questionnaire (EQ-5D).
Descriptive EQ-5D at 5 years
|
0.82 units on a scale
Standard Deviation 0.20
|
|
Investigation of Clinical Performance and Patient Outcome With the EuroQuol-5 Dimension Health Questionnaire (EQ-5D).
Descriptive EQ-5D at 7 years
|
0.83 units on a scale
Standard Deviation 0.19
|
Adverse Events
Scorpio NRG CR Total Knee System
Serious events: 88 serious events
Other events: 15 other events
Deaths: 10 deaths
Serious adverse events
| Measure |
Scorpio NRG CR Total Knee System
n=205 participants at risk
Primary total knee replacement
Primary total knee replacement (Scorpio NRG CR Total Knee System): Scorpio NRG CR Total Knee System
|
|---|---|
|
Musculoskeletal and connective tissue disorders
Quadriceps tendon rupture
|
0.49%
1/205 • Number of events 2 • Recording of Adverse Events ongoing from when the subject has signed the informed consent up to 5 years follow-up or optional 7 years follow-up.
|
|
Musculoskeletal and connective tissue disorders
Inlay wear
|
0.49%
1/205 • Number of events 1 • Recording of Adverse Events ongoing from when the subject has signed the informed consent up to 5 years follow-up or optional 7 years follow-up.
|
|
Musculoskeletal and connective tissue disorders
Instability
|
0.98%
2/205 • Number of events 2 • Recording of Adverse Events ongoing from when the subject has signed the informed consent up to 5 years follow-up or optional 7 years follow-up.
|
|
Musculoskeletal and connective tissue disorders
Aseptic loosening
|
0.98%
2/205 • Number of events 2 • Recording of Adverse Events ongoing from when the subject has signed the informed consent up to 5 years follow-up or optional 7 years follow-up.
|
|
Musculoskeletal and connective tissue disorders
Post cruciate ligament rupture
|
0.98%
2/205 • Number of events 2 • Recording of Adverse Events ongoing from when the subject has signed the informed consent up to 5 years follow-up or optional 7 years follow-up.
|
|
Musculoskeletal and connective tissue disorders
Great toe surgery
|
1.5%
3/205 • Number of events 4 • Recording of Adverse Events ongoing from when the subject has signed the informed consent up to 5 years follow-up or optional 7 years follow-up.
|
|
Musculoskeletal and connective tissue disorders
Retropatellar arthritis
|
0.98%
2/205 • Number of events 2 • Recording of Adverse Events ongoing from when the subject has signed the informed consent up to 5 years follow-up or optional 7 years follow-up.
|
|
Musculoskeletal and connective tissue disorders
Arthrofibrosis
|
2.4%
5/205 • Number of events 6 • Recording of Adverse Events ongoing from when the subject has signed the informed consent up to 5 years follow-up or optional 7 years follow-up.
|
|
Musculoskeletal and connective tissue disorders
Shoulder tendon rupture
|
0.49%
1/205 • Number of events 1 • Recording of Adverse Events ongoing from when the subject has signed the informed consent up to 5 years follow-up or optional 7 years follow-up.
|
|
Musculoskeletal and connective tissue disorders
Carpal tunnel syndrome
|
0.49%
1/205 • Number of events 1 • Recording of Adverse Events ongoing from when the subject has signed the informed consent up to 5 years follow-up or optional 7 years follow-up.
|
|
Musculoskeletal and connective tissue disorders
Hemarthrosis
|
0.49%
1/205 • Number of events 1 • Recording of Adverse Events ongoing from when the subject has signed the informed consent up to 5 years follow-up or optional 7 years follow-up.
|
|
Musculoskeletal and connective tissue disorders
Elbow fracture
|
0.49%
1/205 • Number of events 1 • Recording of Adverse Events ongoing from when the subject has signed the informed consent up to 5 years follow-up or optional 7 years follow-up.
|
|
Musculoskeletal and connective tissue disorders
Per-trochanteric fracture
|
0.49%
1/205 • Number of events 1 • Recording of Adverse Events ongoing from when the subject has signed the informed consent up to 5 years follow-up or optional 7 years follow-up.
|
|
Musculoskeletal and connective tissue disorders
Knee pain
|
0.49%
1/205 • Number of events 1 • Recording of Adverse Events ongoing from when the subject has signed the informed consent up to 5 years follow-up or optional 7 years follow-up.
|
|
Musculoskeletal and connective tissue disorders
Ankle arthrosis
|
0.49%
1/205 • Number of events 1 • Recording of Adverse Events ongoing from when the subject has signed the informed consent up to 5 years follow-up or optional 7 years follow-up.
|
|
Musculoskeletal and connective tissue disorders
Patella subluxation
|
0.49%
1/205 • Number of events 1 • Recording of Adverse Events ongoing from when the subject has signed the informed consent up to 5 years follow-up or optional 7 years follow-up.
|
|
Musculoskeletal and connective tissue disorders
Adhesion
|
0.49%
1/205 • Number of events 1 • Recording of Adverse Events ongoing from when the subject has signed the informed consent up to 5 years follow-up or optional 7 years follow-up.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer
|
8.3%
17/205 • Number of events 18 • Recording of Adverse Events ongoing from when the subject has signed the informed consent up to 5 years follow-up or optional 7 years follow-up.
|
|
Cardiac disorders
Myocard infarction
|
3.4%
7/205 • Number of events 7 • Recording of Adverse Events ongoing from when the subject has signed the informed consent up to 5 years follow-up or optional 7 years follow-up.
|
|
Cardiac disorders
Heart valve disease
|
0.98%
2/205 • Number of events 2 • Recording of Adverse Events ongoing from when the subject has signed the informed consent up to 5 years follow-up or optional 7 years follow-up.
|
|
Cardiac disorders
Cardiovascular collapse
|
0.98%
2/205 • Number of events 2 • Recording of Adverse Events ongoing from when the subject has signed the informed consent up to 5 years follow-up or optional 7 years follow-up.
|
|
Cardiac disorders
Coronary artery disease
|
1.5%
3/205 • Number of events 3 • Recording of Adverse Events ongoing from when the subject has signed the informed consent up to 5 years follow-up or optional 7 years follow-up.
|
|
Cardiac disorders
Cehst pain
|
0.49%
1/205 • Number of events 1 • Recording of Adverse Events ongoing from when the subject has signed the informed consent up to 5 years follow-up or optional 7 years follow-up.
|
|
Cardiac disorders
Heart failure and dyspnea
|
0.49%
1/205 • Number of events 1 • Recording of Adverse Events ongoing from when the subject has signed the informed consent up to 5 years follow-up or optional 7 years follow-up.
|
|
Gastrointestinal disorders
Diverticulitis
|
0.49%
1/205 • Number of events 1 • Recording of Adverse Events ongoing from when the subject has signed the informed consent up to 5 years follow-up or optional 7 years follow-up.
|
|
Gastrointestinal disorders
Ileus
|
0.49%
1/205 • Number of events 1 • Recording of Adverse Events ongoing from when the subject has signed the informed consent up to 5 years follow-up or optional 7 years follow-up.
|
|
General disorders
Suicide
|
0.49%
1/205 • Number of events 1 • Recording of Adverse Events ongoing from when the subject has signed the informed consent up to 5 years follow-up or optional 7 years follow-up.
|
|
General disorders
General health issues
|
0.49%
1/205 • Number of events 1 • Recording of Adverse Events ongoing from when the subject has signed the informed consent up to 5 years follow-up or optional 7 years follow-up.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.49%
1/205 • Number of events 1 • Recording of Adverse Events ongoing from when the subject has signed the informed consent up to 5 years follow-up or optional 7 years follow-up.
|
|
Hepatobiliary disorders
Hepatitis E
|
0.49%
1/205 • Number of events 1 • Recording of Adverse Events ongoing from when the subject has signed the informed consent up to 5 years follow-up or optional 7 years follow-up.
|
|
Immune system disorders
Polyarteritis nodosa
|
0.49%
1/205 • Number of events 1 • Recording of Adverse Events ongoing from when the subject has signed the informed consent up to 5 years follow-up or optional 7 years follow-up.
|
|
Infections and infestations
Pneumonia infections
|
2.0%
4/205 • Number of events 4 • Recording of Adverse Events ongoing from when the subject has signed the informed consent up to 5 years follow-up or optional 7 years follow-up.
|
|
Infections and infestations
Deep joint infection
|
0.49%
1/205 • Number of events 1 • Recording of Adverse Events ongoing from when the subject has signed the informed consent up to 5 years follow-up or optional 7 years follow-up.
|
|
Infections and infestations
pre-patellar bursitis
|
0.49%
1/205 • Number of events 1 • Recording of Adverse Events ongoing from when the subject has signed the informed consent up to 5 years follow-up or optional 7 years follow-up.
|
|
Injury, poisoning and procedural complications
head/spinal cord trauma
|
0.98%
2/205 • Number of events 2 • Recording of Adverse Events ongoing from when the subject has signed the informed consent up to 5 years follow-up or optional 7 years follow-up.
|
|
Injury, poisoning and procedural complications
Wound dehiscence/hematoma
|
0.98%
2/205 • Number of events 2 • Recording of Adverse Events ongoing from when the subject has signed the informed consent up to 5 years follow-up or optional 7 years follow-up.
|
|
General disorders
Death unknown cause
|
0.98%
2/205 • Number of events 2 • Recording of Adverse Events ongoing from when the subject has signed the informed consent up to 5 years follow-up or optional 7 years follow-up.
|
|
Nervous system disorders
Dementia
|
0.49%
1/205 • Number of events 1 • Recording of Adverse Events ongoing from when the subject has signed the informed consent up to 5 years follow-up or optional 7 years follow-up.
|
|
Product Issues
Fraxiparine allergy
|
0.49%
1/205 • Number of events 1 • Recording of Adverse Events ongoing from when the subject has signed the informed consent up to 5 years follow-up or optional 7 years follow-up.
|
|
Renal and urinary disorders
Kidney stone
|
0.49%
1/205 • Number of events 1 • Recording of Adverse Events ongoing from when the subject has signed the informed consent up to 5 years follow-up or optional 7 years follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
COPD
|
0.49%
1/205 • Number of events 1 • Recording of Adverse Events ongoing from when the subject has signed the informed consent up to 5 years follow-up or optional 7 years follow-up.
|
|
Skin and subcutaneous tissue disorders
Necrotic wound
|
0.49%
1/205 • Number of events 1 • Recording of Adverse Events ongoing from when the subject has signed the informed consent up to 5 years follow-up or optional 7 years follow-up.
|
|
Surgical and medical procedures
Posterior intervaginal plasty
|
0.49%
1/205 • Number of events 1 • Recording of Adverse Events ongoing from when the subject has signed the informed consent up to 5 years follow-up or optional 7 years follow-up.
|
|
Vascular disorders
Pulmonary embolism
|
0.49%
1/205 • Number of events 1 • Recording of Adverse Events ongoing from when the subject has signed the informed consent up to 5 years follow-up or optional 7 years follow-up.
|
|
Vascular disorders
Stroke
|
0.98%
2/205 • Number of events 2 • Recording of Adverse Events ongoing from when the subject has signed the informed consent up to 5 years follow-up or optional 7 years follow-up.
|
Other adverse events
| Measure |
Scorpio NRG CR Total Knee System
n=205 participants at risk
Primary total knee replacement
Primary total knee replacement (Scorpio NRG CR Total Knee System): Scorpio NRG CR Total Knee System
|
|---|---|
|
Musculoskeletal and connective tissue disorders
Knee pain
|
7.3%
15/205 • Number of events 15 • Recording of Adverse Events ongoing from when the subject has signed the informed consent up to 5 years follow-up or optional 7 years follow-up.
|
Additional Information
Britta von den Brincken, Sr. Clinical Study Manager
Stryker
Phone: +491638999202
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60