Trial Outcomes & Findings for ROSA Total Knee Post Market Study EMEA (NCT NCT04338893)
NCT ID: NCT04338893
Last Updated: 2026-05-12
Results Overview
Evaluate the accuracy of implant component alignment for ROSA Total Knee robotic instrumentation compared to conventional instrumentation, by measuring femoral rotation in the axial plane using pre op and post op CT assessments.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
252 participants
Primary outcome timeframe
Pre-operative, 3 months
Results posted on
2026-05-12
Participant Flow
31 patients not assigned to any group: 27 screen failures, 1 cancelled operation, 3 recorded as lost to follow-up for other reasons
Participant milestones
| Measure |
Robotic
Total knee arthroplasty performed with ROSA Total Knee Robotic instrumentation
|
Conventional
Total knee arthroplasty performed with conventional instrumentation
|
|---|---|---|
|
Overall Study
STARTED
|
120
|
101
|
|
Overall Study
COMPLETED
|
85
|
75
|
|
Overall Study
NOT COMPLETED
|
35
|
26
|
Reasons for withdrawal
| Measure |
Robotic
Total knee arthroplasty performed with ROSA Total Knee Robotic instrumentation
|
Conventional
Total knee arthroplasty performed with conventional instrumentation
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
10
|
10
|
|
Overall Study
Death
|
0
|
1
|
|
Overall Study
Adverse Event
|
2
|
0
|
|
Overall Study
Lost to Follow-up
|
23
|
15
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Robotic
n=120 Participants
Total knee arthroplasty performed with ROSA Total Knee Robotic instrumentation
|
Conventional
n=101 Participants
Total knee arthroplasty performed with conventional instrumentation
|
Total
n=221 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
70.6 years
STANDARD_DEVIATION 7.9 • n=120 Participants
|
70.4 years
STANDARD_DEVIATION 8.7 • n=101 Participants
|
70.5 years
STANDARD_DEVIATION 8.3 • n=221 Participants
|
|
Sex: Female, Male
Female
|
75 Participants
n=120 Participants
|
66 Participants
n=101 Participants
|
141 Participants
n=221 Participants
|
|
Sex: Female, Male
Male
|
45 Participants
n=120 Participants
|
35 Participants
n=101 Participants
|
80 Participants
n=221 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: Pre-operative, 3 monthsPopulation: CT scans were taken from participants enrolled in this patients sub-cohort; however, following longer study duration and fewer enrolled patients than originally planned, the scans analysis was not performed, as the reduced sample size limited interpretability, resources were reallocated, and the research question was no longer considered novel. The study documents did not specify what to do in the case of incomplete enrollment and there are no plans to process the images in the future.
Evaluate the accuracy of implant component alignment for ROSA Total Knee robotic instrumentation compared to conventional instrumentation, by measuring femoral rotation in the axial plane using pre op and post op CT assessments.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: IntraoperativePopulation: Information not collected for 2 conventional patients
Measure operative workflow efficiency by recording following time points during surgery: Patient in -and out time, incision - and incision closed time
Outcome measures
| Measure |
Robotic
n=120 Participants
Total knee arthroplasty performed with ROSA Total Knee Robotic instrumentation
|
Conventional
n=99 Participants
Total knee arthroplasty performed with conventional instrumentation
|
|---|---|---|
|
Operative Workflow Efficiency
Time from patient in to patient out
|
161.6 minutes
Standard Deviation 30.9
|
138.8 minutes
Standard Deviation 27.9
|
|
Operative Workflow Efficiency
Time from incision cut to incision closed
|
91.5 minutes
Standard Deviation 21.1
|
77.5 minutes
Standard Deviation 20.3
|
SECONDARY outcome
Timeframe: Pre-operative, 6 weeks, 3 months, 1 yearPopulation: Some data points are missing due to missed follow-up visits or incomplete form completion
The OKS is a patient-reported outcome questionnaire that was developed to specifically assess the patient's perspective of outcome following TKA. The OKS consists of twelve questions covering function and pain associated with the knee. To calculate the total score, each question is scored from 0 (worst outcome) to 4 (best outcome) and the sum of all 12 items is reported with a maximum of 48, representing the best score possible. The outcome score can be categorized as Excellent: \> 41; Good: 34 - 41; Fair: 27 - 33; Poor: \< 27
Outcome measures
| Measure |
Robotic
n=120 Participants
Total knee arthroplasty performed with ROSA Total Knee Robotic instrumentation
|
Conventional
n=101 Participants
Total knee arthroplasty performed with conventional instrumentation
|
|---|---|---|
|
Oxford Knee Score (OKS)
Pre-operative
|
21.5 score on a scale
Standard Deviation 7.5
|
20.6 score on a scale
Standard Deviation 6.8
|
|
Oxford Knee Score (OKS)
6 weeks
|
30.5 score on a scale
Standard Deviation 7.1
|
29.0 score on a scale
Standard Deviation 7.8
|
|
Oxford Knee Score (OKS)
3 months
|
36.3 score on a scale
Standard Deviation 8.0
|
35.0 score on a scale
Standard Deviation 9.6
|
|
Oxford Knee Score (OKS)
1 year
|
38.5 score on a scale
Standard Deviation 8.9
|
38.2 score on a scale
Standard Deviation 9.2
|
SECONDARY outcome
Timeframe: Pre-operative, 6 weeks, 3 months, 1 yearPopulation: Some data points are missing due to missed follow-up visits or incomplete form completion
The EQ-5D is a standardized instrument widely used to measure health status, and it is a self-reported assessment about the patient's quality of life. The questionnaire includes 5 questions referring to mobility, self-care, daily/usual activities, pain/discomfort and anxiety/depression. For EQ-5D-5L, each question can be answered in five ways, indicating no, slight, moderate, severe or extreme pain. In the derived EQ-5D-5L score, the highest score is 1 and the lowest score is -0.573; negative numbers correspond to a self-assessed health state worse than being dead.
Outcome measures
| Measure |
Robotic
n=120 Participants
Total knee arthroplasty performed with ROSA Total Knee Robotic instrumentation
|
Conventional
n=101 Participants
Total knee arthroplasty performed with conventional instrumentation
|
|---|---|---|
|
EuroQol 5D (EQ-5D) - Score
Pre-operative
|
0.371 score on a scale
Standard Deviation 0.336
|
0.388 score on a scale
Standard Deviation 0.303
|
|
EuroQol 5D (EQ-5D) - Score
6 weeks
|
0.717 score on a scale
Standard Deviation 0.204
|
0.691 score on a scale
Standard Deviation 0.232
|
|
EuroQol 5D (EQ-5D) - Score
3 months
|
0.816 score on a scale
Standard Deviation 0.160
|
0.762 score on a scale
Standard Deviation 0.266
|
|
EuroQol 5D (EQ-5D) - Score
1 year
|
0.865 score on a scale
Standard Deviation 0.179
|
0.817 score on a scale
Standard Deviation 0.238
|
SECONDARY outcome
Timeframe: Pre-operative, 6 weeks, 3 months, 1 yearPopulation: Some data points are missing due to missed follow-up visits or incomplete form completion
The EQ-5D is a standardized instrument widely used to measure health status. It is a self-reported assessment about the patient's quality of life composed of two parts: a questionnaire and a visual analogue scale (VAS). The VAS is a vertical scale ranging from 100 ('The best health you can imagine') to 0 ('The worst health you can imagine') where the patient reports his/her self-rated health.
Outcome measures
| Measure |
Robotic
n=120 Participants
Total knee arthroplasty performed with ROSA Total Knee Robotic instrumentation
|
Conventional
n=101 Participants
Total knee arthroplasty performed with conventional instrumentation
|
|---|---|---|
|
EuroQol 5D (EQ-5D) VAS Scale
3 months
|
78.6 score on a scale
Standard Deviation 15.4
|
78.1 score on a scale
Standard Deviation 14.7
|
|
EuroQol 5D (EQ-5D) VAS Scale
1 year
|
76.1 score on a scale
Standard Deviation 18.8
|
78.6 score on a scale
Standard Deviation 17.7
|
|
EuroQol 5D (EQ-5D) VAS Scale
Pre-operative
|
64.8 score on a scale
Standard Deviation 18.0
|
64.6 score on a scale
Standard Deviation 20.0
|
|
EuroQol 5D (EQ-5D) VAS Scale
6 weeks
|
73.8 score on a scale
Standard Deviation 15.1
|
73.9 score on a scale
Standard Deviation 15.6
|
SECONDARY outcome
Timeframe: Pre-operative, 6 weeks, 3 months, 1 yearPopulation: Some data points are missing due to missed follow-up visits or incomplete form completion
The NRS Pain is an outcome measure of pain intensity in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain. The common format is a horizontal bar or line. Scores range from 0-10 points, with 0 representing "no pain" to 10 representing "worst imaginable pain".
Outcome measures
| Measure |
Robotic
n=120 Participants
Total knee arthroplasty performed with ROSA Total Knee Robotic instrumentation
|
Conventional
n=101 Participants
Total knee arthroplasty performed with conventional instrumentation
|
|---|---|---|
|
NRS (Numeric Rating Scale) Pain
Pre-operative
|
7.2 score on a scale
Standard Deviation 2.0
|
7.5 score on a scale
Standard Deviation 1.5
|
|
NRS (Numeric Rating Scale) Pain
6 weeks
|
3.4 score on a scale
Standard Deviation 2.0
|
3.2 score on a scale
Standard Deviation 2.1
|
|
NRS (Numeric Rating Scale) Pain
3 months
|
2.3 score on a scale
Standard Deviation 2.2
|
2.3 score on a scale
Standard Deviation 2.1
|
|
NRS (Numeric Rating Scale) Pain
1 year
|
1.5 score on a scale
Standard Deviation 2.0
|
1.7 score on a scale
Standard Deviation 1.9
|
SECONDARY outcome
Timeframe: Pre-operative, 6 weeks, 3 months, 1 yearPopulation: Some data points are missing due to missed follow-up visits or incomplete form completion
The FJS-12 is a patient-reported outcome questionnaire that was developed to specifically assess the patient's level of awareness of having a joint prosthesis during daily activities. The FJS consists of twelve questions covering function and pain associated with the knee. For each question, there is a choice of five answers between never (0), almost never (1), seldom (2), sometimes (3) and mostly (4). All scores are summed up and divided by the number of completed items. This value is then multiplied by 25 and thereafter subtracted from 100. An outcome score of 100 (highest possible score) indicates the lowest level of awareness of having a joint prosthesis, while a total score of 0 indicates the highest level of awareness of having a joint prosthesis.
Outcome measures
| Measure |
Robotic
n=120 Participants
Total knee arthroplasty performed with ROSA Total Knee Robotic instrumentation
|
Conventional
n=101 Participants
Total knee arthroplasty performed with conventional instrumentation
|
|---|---|---|
|
Forgotten Joint Score (FJS)
Pre-operative
|
21.3 score on a scale
Standard Deviation 14.5
|
17.6 score on a scale
Standard Deviation 13.1
|
|
Forgotten Joint Score (FJS)
6 weeks
|
42.4 score on a scale
Standard Deviation 22.5
|
37.1 score on a scale
Standard Deviation 22.1
|
|
Forgotten Joint Score (FJS)
3 months
|
60.5 score on a scale
Standard Deviation 24.6
|
55.3 score on a scale
Standard Deviation 26.2
|
|
Forgotten Joint Score (FJS)
1 year
|
67.4 score on a scale
Standard Deviation 25.2
|
64.7 score on a scale
Standard Deviation 27.2
|
SECONDARY outcome
Timeframe: 6 weeks, 3 months, 1 yearPopulation: Some data points are missing due to missed follow-up visits or incomplete form completion
Patients were asked to answer the following question: "How satisfied are you with the results of your surgery?" by selecting from the answers: very satisfied, somewhat satisfied, somewhat dissatisfied and very dissatisfied.
Outcome measures
| Measure |
Robotic
n=120 Participants
Total knee arthroplasty performed with ROSA Total Knee Robotic instrumentation
|
Conventional
n=101 Participants
Total knee arthroplasty performed with conventional instrumentation
|
|---|---|---|
|
Patient Satisfaction - Question 1
3 months · Somewhat dissatisfied
|
6 Participants
|
4 Participants
|
|
Patient Satisfaction - Question 1
3 months · Very dissatisfied
|
1 Participants
|
3 Participants
|
|
Patient Satisfaction - Question 1
1 year · Very satisfied
|
50 Participants
|
44 Participants
|
|
Patient Satisfaction - Question 1
1 year · Somewhat satisfied
|
31 Participants
|
25 Participants
|
|
Patient Satisfaction - Question 1
1 year · Somewhat dissatisfied
|
3 Participants
|
4 Participants
|
|
Patient Satisfaction - Question 1
1 year · Very dissatisfied
|
0 Participants
|
1 Participants
|
|
Patient Satisfaction - Question 1
3 months · Very satisfied
|
62 Participants
|
48 Participants
|
|
Patient Satisfaction - Question 1
3 months · Somewhat satisfied
|
35 Participants
|
33 Participants
|
|
Patient Satisfaction - Question 1
6 weeks · Very satisfied
|
54 Participants
|
49 Participants
|
|
Patient Satisfaction - Question 1
6 weeks · Somewhat satisfied
|
42 Participants
|
29 Participants
|
|
Patient Satisfaction - Question 1
6 weeks · Somewhat dissatisfied
|
8 Participants
|
10 Participants
|
|
Patient Satisfaction - Question 1
6 weeks · Very dissatisfied
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 6 weeks, 3 months, 1 yearPopulation: Some data points are missing due to missed follow-up visits or incomplete form completion
Patients were asked to answer the following question: "How satisfied are you with the results of your surgery for improving your pain?" by selecting from the answers: very satisfied, somewhat satisfied, somewhat dissatisfied and very dissatisfied.
Outcome measures
| Measure |
Robotic
n=120 Participants
Total knee arthroplasty performed with ROSA Total Knee Robotic instrumentation
|
Conventional
n=101 Participants
Total knee arthroplasty performed with conventional instrumentation
|
|---|---|---|
|
Patient Satisfaction - Question 2
6 weeks · Very satisified
|
41 Participants
|
31 Participants
|
|
Patient Satisfaction - Question 2
6 weeks · Somewhat satisfied
|
51 Participants
|
43 Participants
|
|
Patient Satisfaction - Question 2
6 weeks · Somewhat dissatisfied
|
11 Participants
|
15 Participants
|
|
Patient Satisfaction - Question 2
6 weeks · Very dissatisfied
|
3 Participants
|
0 Participants
|
|
Patient Satisfaction - Question 2
3 months · Very satisified
|
63 Participants
|
49 Participants
|
|
Patient Satisfaction - Question 2
3 months · Somewhat satisfied
|
31 Participants
|
31 Participants
|
|
Patient Satisfaction - Question 2
3 months · Somewhat dissatisfied
|
9 Participants
|
5 Participants
|
|
Patient Satisfaction - Question 2
3 months · Very dissatisfied
|
0 Participants
|
3 Participants
|
|
Patient Satisfaction - Question 2
1 year · Very satisified
|
51 Participants
|
53 Participants
|
|
Patient Satisfaction - Question 2
1 year · Somewhat satisfied
|
28 Participants
|
14 Participants
|
|
Patient Satisfaction - Question 2
1 year · Somewhat dissatisfied
|
4 Participants
|
4 Participants
|
|
Patient Satisfaction - Question 2
1 year · Very dissatisfied
|
1 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 6 weeks, 3 months, 1 yearPopulation: Some data points are missing due to missed follow-up visits or incomplete form completion
Patients were asked to answer the following question: "How satisfied are you with the results of your surgery for improving your ability to do home or yard work?" by selecting from the answers: very satisfied, somewhat satisfied, somewhat dissatisfied and very dissatisfied.
Outcome measures
| Measure |
Robotic
n=120 Participants
Total knee arthroplasty performed with ROSA Total Knee Robotic instrumentation
|
Conventional
n=101 Participants
Total knee arthroplasty performed with conventional instrumentation
|
|---|---|---|
|
Patient Satisfaction - Question 3
6 weeks · Very satisified
|
34 Participants
|
13 Participants
|
|
Patient Satisfaction - Question 3
6 weeks · Somewhat satisfied
|
57 Participants
|
60 Participants
|
|
Patient Satisfaction - Question 3
6 weeks · Somewhat dissatisfied
|
12 Participants
|
15 Participants
|
|
Patient Satisfaction - Question 3
6 weeks · Very dissatisfied
|
3 Participants
|
1 Participants
|
|
Patient Satisfaction - Question 3
3 months · Very satisified
|
56 Participants
|
33 Participants
|
|
Patient Satisfaction - Question 3
3 months · Somewhat satisfied
|
40 Participants
|
42 Participants
|
|
Patient Satisfaction - Question 3
3 months · Somewhat dissatisfied
|
6 Participants
|
8 Participants
|
|
Patient Satisfaction - Question 3
3 months · Very dissatisfied
|
2 Participants
|
5 Participants
|
|
Patient Satisfaction - Question 3
1 year · Very satisified
|
46 Participants
|
36 Participants
|
|
Patient Satisfaction - Question 3
1 year · Somewhat satisfied
|
32 Participants
|
29 Participants
|
|
Patient Satisfaction - Question 3
1 year · Somewhat dissatisfied
|
4 Participants
|
9 Participants
|
|
Patient Satisfaction - Question 3
1 year · Very dissatisfied
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 6 weeks, 3 months, 1 yearPopulation: Some data points are missing due to missed follow-up visits or incomplete form completion
Patients were asked to answer the following question: "How satisfied are you with the results of your surgery for improving your ability to do recreational activities?" by selecting from the answers: very satisfied, somewhat satisfied, somewhat dissatisfied and very dissatisfied.
Outcome measures
| Measure |
Robotic
n=120 Participants
Total knee arthroplasty performed with ROSA Total Knee Robotic instrumentation
|
Conventional
n=101 Participants
Total knee arthroplasty performed with conventional instrumentation
|
|---|---|---|
|
Patient Satisfaction - Question 4
6 weeks · Very satisified
|
34 Participants
|
17 Participants
|
|
Patient Satisfaction - Question 4
6 weeks · Somewhat satisfied
|
54 Participants
|
52 Participants
|
|
Patient Satisfaction - Question 4
1 year · Very dissatisfied
|
1 Participants
|
0 Participants
|
|
Patient Satisfaction - Question 4
6 weeks · Somewhat dissatisfied
|
14 Participants
|
16 Participants
|
|
Patient Satisfaction - Question 4
6 weeks · Very dissatisfied
|
4 Participants
|
4 Participants
|
|
Patient Satisfaction - Question 4
3 months · Very satisified
|
55 Participants
|
37 Participants
|
|
Patient Satisfaction - Question 4
3 months · Somewhat satisfied
|
37 Participants
|
36 Participants
|
|
Patient Satisfaction - Question 4
3 months · Somewhat dissatisfied
|
10 Participants
|
10 Participants
|
|
Patient Satisfaction - Question 4
3 months · Very dissatisfied
|
2 Participants
|
5 Participants
|
|
Patient Satisfaction - Question 4
1 year · Very satisified
|
45 Participants
|
43 Participants
|
|
Patient Satisfaction - Question 4
1 year · Somewhat satisfied
|
33 Participants
|
22 Participants
|
|
Patient Satisfaction - Question 4
1 year · Somewhat dissatisfied
|
3 Participants
|
9 Participants
|
Adverse Events
Robotic
Serious events: 19 serious events
Other events: 21 other events
Deaths: 0 deaths
Conventional
Serious events: 13 serious events
Other events: 21 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Robotic
n=120 participants at risk
Total knee arthroplasty performed with ROSA Total Knee Robotic instrumentation
|
Conventional
n=101 participants at risk
Total knee arthroplasty performed with conventional instrumentation
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Vastus Lateralis Querruptur
|
0.00%
0/120 • From study start up to 1 year post-operatively
Adverse events have been documented continuously by checking with the study patients at every follow-up visit.
|
0.99%
1/101 • From study start up to 1 year post-operatively
Adverse events have been documented continuously by checking with the study patients at every follow-up visit.
|
|
Musculoskeletal and connective tissue disorders
Stiffness/Limited ROM
|
0.83%
1/120 • From study start up to 1 year post-operatively
Adverse events have been documented continuously by checking with the study patients at every follow-up visit.
|
3.0%
3/101 • From study start up to 1 year post-operatively
Adverse events have been documented continuously by checking with the study patients at every follow-up visit.
|
|
Musculoskeletal and connective tissue disorders
Knee pain
|
0.00%
0/120 • From study start up to 1 year post-operatively
Adverse events have been documented continuously by checking with the study patients at every follow-up visit.
|
0.99%
1/101 • From study start up to 1 year post-operatively
Adverse events have been documented continuously by checking with the study patients at every follow-up visit.
|
|
Skin and subcutaneous tissue disorders
Wound complication
|
0.83%
1/120 • From study start up to 1 year post-operatively
Adverse events have been documented continuously by checking with the study patients at every follow-up visit.
|
0.99%
1/101 • From study start up to 1 year post-operatively
Adverse events have been documented continuously by checking with the study patients at every follow-up visit.
|
|
Gastrointestinal disorders
Diverticulitis
|
0.83%
1/120 • From study start up to 1 year post-operatively
Adverse events have been documented continuously by checking with the study patients at every follow-up visit.
|
0.00%
0/101 • From study start up to 1 year post-operatively
Adverse events have been documented continuously by checking with the study patients at every follow-up visit.
|
|
Cardiac disorders
Coronary heart disease
|
0.83%
1/120 • From study start up to 1 year post-operatively
Adverse events have been documented continuously by checking with the study patients at every follow-up visit.
|
0.00%
0/101 • From study start up to 1 year post-operatively
Adverse events have been documented continuously by checking with the study patients at every follow-up visit.
|
|
Surgical and medical procedures
Cardiac catheterization
|
0.83%
1/120 • From study start up to 1 year post-operatively
Adverse events have been documented continuously by checking with the study patients at every follow-up visit.
|
0.99%
1/101 • From study start up to 1 year post-operatively
Adverse events have been documented continuously by checking with the study patients at every follow-up visit.
|
|
Surgical and medical procedures
Shoulder replacement
|
0.83%
1/120 • From study start up to 1 year post-operatively
Adverse events have been documented continuously by checking with the study patients at every follow-up visit.
|
0.00%
0/101 • From study start up to 1 year post-operatively
Adverse events have been documented continuously by checking with the study patients at every follow-up visit.
|
|
Cardiac disorders
Myocardial infarction
|
0.83%
1/120 • From study start up to 1 year post-operatively
Adverse events have been documented continuously by checking with the study patients at every follow-up visit.
|
0.00%
0/101 • From study start up to 1 year post-operatively
Adverse events have been documented continuously by checking with the study patients at every follow-up visit.
|
|
Renal and urinary disorders
Kidney Failure
|
0.83%
1/120 • From study start up to 1 year post-operatively
Adverse events have been documented continuously by checking with the study patients at every follow-up visit.
|
0.00%
0/101 • From study start up to 1 year post-operatively
Adverse events have been documented continuously by checking with the study patients at every follow-up visit.
|
|
Surgical and medical procedures
Cholecystitis
|
0.83%
1/120 • From study start up to 1 year post-operatively
Adverse events have been documented continuously by checking with the study patients at every follow-up visit.
|
0.00%
0/101 • From study start up to 1 year post-operatively
Adverse events have been documented continuously by checking with the study patients at every follow-up visit.
|
|
Surgical and medical procedures
Contralateral Knee Replacement
|
1.7%
2/120 • From study start up to 1 year post-operatively
Adverse events have been documented continuously by checking with the study patients at every follow-up visit.
|
2.0%
2/101 • From study start up to 1 year post-operatively
Adverse events have been documented continuously by checking with the study patients at every follow-up visit.
|
|
Surgical and medical procedures
Ureteral stenosis
|
0.83%
1/120 • From study start up to 1 year post-operatively
Adverse events have been documented continuously by checking with the study patients at every follow-up visit.
|
0.00%
0/101 • From study start up to 1 year post-operatively
Adverse events have been documented continuously by checking with the study patients at every follow-up visit.
|
|
Surgical and medical procedures
Nephrostomy
|
0.83%
1/120 • From study start up to 1 year post-operatively
Adverse events have been documented continuously by checking with the study patients at every follow-up visit.
|
0.00%
0/101 • From study start up to 1 year post-operatively
Adverse events have been documented continuously by checking with the study patients at every follow-up visit.
|
|
Nervous system disorders
Post-operative encephalopathy
|
0.00%
0/120 • From study start up to 1 year post-operatively
Adverse events have been documented continuously by checking with the study patients at every follow-up visit.
|
0.99%
1/101 • From study start up to 1 year post-operatively
Adverse events have been documented continuously by checking with the study patients at every follow-up visit.
|
|
Surgical and medical procedures
Gastric bypass
|
0.83%
1/120 • From study start up to 1 year post-operatively
Adverse events have been documented continuously by checking with the study patients at every follow-up visit.
|
0.00%
0/101 • From study start up to 1 year post-operatively
Adverse events have been documented continuously by checking with the study patients at every follow-up visit.
|
|
Surgical and medical procedures
Discectomy
|
0.00%
0/120 • From study start up to 1 year post-operatively
Adverse events have been documented continuously by checking with the study patients at every follow-up visit.
|
0.99%
1/101 • From study start up to 1 year post-operatively
Adverse events have been documented continuously by checking with the study patients at every follow-up visit.
|
|
Surgical and medical procedures
Infection (knee)
|
0.83%
1/120 • From study start up to 1 year post-operatively
Adverse events have been documented continuously by checking with the study patients at every follow-up visit.
|
0.00%
0/101 • From study start up to 1 year post-operatively
Adverse events have been documented continuously by checking with the study patients at every follow-up visit.
|
|
Surgical and medical procedures
Post-operative cement leftover
|
0.83%
1/120 • From study start up to 1 year post-operatively
Adverse events have been documented continuously by checking with the study patients at every follow-up visit.
|
0.00%
0/101 • From study start up to 1 year post-operatively
Adverse events have been documented continuously by checking with the study patients at every follow-up visit.
|
|
Product Issues
Robotic malfunction
|
0.83%
1/120 • From study start up to 1 year post-operatively
Adverse events have been documented continuously by checking with the study patients at every follow-up visit.
|
0.00%
0/101 • From study start up to 1 year post-operatively
Adverse events have been documented continuously by checking with the study patients at every follow-up visit.
|
|
Blood and lymphatic system disorders
Effusion/Swelling/Edema
|
1.7%
2/120 • From study start up to 1 year post-operatively
Adverse events have been documented continuously by checking with the study patients at every follow-up visit.
|
2.0%
2/101 • From study start up to 1 year post-operatively
Adverse events have been documented continuously by checking with the study patients at every follow-up visit.
|
Other adverse events
| Measure |
Robotic
n=120 participants at risk
Total knee arthroplasty performed with ROSA Total Knee Robotic instrumentation
|
Conventional
n=101 participants at risk
Total knee arthroplasty performed with conventional instrumentation
|
|---|---|---|
|
Surgical and medical procedures
Eye surgery
|
0.83%
1/120 • From study start up to 1 year post-operatively
Adverse events have been documented continuously by checking with the study patients at every follow-up visit.
|
0.99%
1/101 • From study start up to 1 year post-operatively
Adverse events have been documented continuously by checking with the study patients at every follow-up visit.
|
|
Musculoskeletal and connective tissue disorders
Restricted Mobility Patella / Abnormal Patellar Tracking
|
5.0%
6/120 • From study start up to 1 year post-operatively
Adverse events have been documented continuously by checking with the study patients at every follow-up visit.
|
5.9%
6/101 • From study start up to 1 year post-operatively
Adverse events have been documented continuously by checking with the study patients at every follow-up visit.
|
|
Musculoskeletal and connective tissue disorders
Stiffness/Limited ROM
|
1.7%
2/120 • From study start up to 1 year post-operatively
Adverse events have been documented continuously by checking with the study patients at every follow-up visit.
|
0.99%
1/101 • From study start up to 1 year post-operatively
Adverse events have been documented continuously by checking with the study patients at every follow-up visit.
|
|
Vascular disorders
Effusion/Swelling/Edema
|
1.7%
2/120 • From study start up to 1 year post-operatively
Adverse events have been documented continuously by checking with the study patients at every follow-up visit.
|
2.0%
2/101 • From study start up to 1 year post-operatively
Adverse events have been documented continuously by checking with the study patients at every follow-up visit.
|
|
Musculoskeletal and connective tissue disorders
Spinal stenosis
|
0.83%
1/120 • From study start up to 1 year post-operatively
Adverse events have been documented continuously by checking with the study patients at every follow-up visit.
|
0.99%
1/101 • From study start up to 1 year post-operatively
Adverse events have been documented continuously by checking with the study patients at every follow-up visit.
|
|
Musculoskeletal and connective tissue disorders
Dental-related problems
|
1.7%
2/120 • From study start up to 1 year post-operatively
Adverse events have been documented continuously by checking with the study patients at every follow-up visit.
|
3.0%
3/101 • From study start up to 1 year post-operatively
Adverse events have been documented continuously by checking with the study patients at every follow-up visit.
|
|
Infections and infestations
Covid infection
|
4.2%
5/120 • From study start up to 1 year post-operatively
Adverse events have been documented continuously by checking with the study patients at every follow-up visit.
|
5.0%
5/101 • From study start up to 1 year post-operatively
Adverse events have been documented continuously by checking with the study patients at every follow-up visit.
|
|
Cardiac disorders
Tachycardia
|
0.83%
1/120 • From study start up to 1 year post-operatively
Adverse events have been documented continuously by checking with the study patients at every follow-up visit.
|
0.99%
1/101 • From study start up to 1 year post-operatively
Adverse events have been documented continuously by checking with the study patients at every follow-up visit.
|
|
Surgical and medical procedures
Heart surgery
|
0.83%
1/120 • From study start up to 1 year post-operatively
Adverse events have been documented continuously by checking with the study patients at every follow-up visit.
|
0.99%
1/101 • From study start up to 1 year post-operatively
Adverse events have been documented continuously by checking with the study patients at every follow-up visit.
|
Additional Information
Chiara Griffoni, Clinical Project Senior Lead
Zimmer Biomet
Phone: +41 79 560 16 28
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60