Trial Outcomes & Findings for A Multicenter Prospective Randomized Control Study on Persona Total Knee System vs NexGen (NCT NCT03073941)
NCT ID: NCT03073941
Last Updated: 2025-01-17
Results Overview
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
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
NA
Target enrollment
332 participants
Primary outcome timeframe
3 months, 1 year and 2 years postoperatively
Results posted on
2025-01-17
Participant Flow
18 patients not assigned to any group: 5 rescinded consent before surgery, 13 recorded as lost to follow-up for other reasons
Participant milestones
| Measure |
Persona CR
Patients who received a Persona CR total knee implant
|
NexGen CR
Patients who received a NexGen CR total knee implant
|
|---|---|---|
|
Overall Study
STARTED
|
157
|
157
|
|
Overall Study
COMPLETED
|
146
|
145
|
|
Overall Study
NOT COMPLETED
|
11
|
12
|
Reasons for withdrawal
| Measure |
Persona CR
Patients who received a Persona CR total knee implant
|
NexGen CR
Patients who received a NexGen CR total knee implant
|
|---|---|---|
|
Overall Study
Received non-study device intraoperatively
|
0
|
2
|
|
Overall Study
Death
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
3
|
|
Overall Study
Lost to Follow-up
|
5
|
4
|
|
Overall Study
Adverse Event
|
4
|
2
|
|
Overall Study
Met an exclusion criterion
|
0
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Persona CR
n=156 Participants
Patients who received a Persona CR total knee implant
|
NexGen CR
n=155 Participants
Patients who received a NexGen CR total knee implant
|
Total
n=311 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
68.1 years
STANDARD_DEVIATION 8.2 • n=156 Participants
|
67.7 years
STANDARD_DEVIATION 9.0 • n=155 Participants
|
67.9 years
STANDARD_DEVIATION 8.6 • n=311 Participants
|
|
Sex: Female, Male
Female
|
99 Participants
n=156 Participants
|
90 Participants
n=155 Participants
|
189 Participants
n=311 Participants
|
|
Sex: Female, Male
Male
|
57 Participants
n=156 Participants
|
65 Participants
n=155 Participants
|
122 Participants
n=311 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Denmark
|
156 participants
n=156 Participants
|
155 participants
n=155 Participants
|
311 participants
n=311 Participants
|
PRIMARY outcome
Timeframe: 3 months, 1 year and 2 years postoperativelyPopulation: 157 patients were enrolled and randomized to each group, but 3 cases were excluded intraoperatively: 2 in the NexGen group and 1 in the Persona group. Additionally, 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 |
Persona CR
n=156 Participants
Patients who received a Persona CR total knee implant
|
NexGen CR
n=155 Participants
Patients who received a NexGen CR total knee implant
|
|---|---|---|
|
Oxford Knee Score
Preoperative
|
22.1 score on a scale
Standard Deviation 6.7
|
22.2 score on a scale
Standard Deviation 6.5
|
|
Oxford Knee Score
3 months
|
33.5 score on a scale
Standard Deviation 7.8
|
32.9 score on a scale
Standard Deviation 7.9
|
|
Oxford Knee Score
1 year
|
39.5 score on a scale
Standard Deviation 7.7
|
38.6 score on a scale
Standard Deviation 7.6
|
|
Oxford Knee Score
2 years
|
40.7 score on a scale
Standard Deviation 7.3
|
40.8 score on a scale
Standard Deviation 6.6
|
SECONDARY outcome
Timeframe: 3 months, 1 year and 2 years postoperativelyPopulation: 157 patients were enrolled and randomized to each group, but 3 cases were excluded intraoperatively: 2 in the NexGen group and 1 in the Persona group. Additionally, some data points are missing due to missed follow-up visits or incomplete form completion
The OKS-APQ is an 8 item questionnaire with each question scored from 0 (worst outcome) to 4 (best outcome). The resulting score is then summed and converted to a score ranging from 0 (worst possible score) to a maximum of 100 (best possible score).
Outcome measures
| Measure |
Persona CR
n=156 Participants
Patients who received a Persona CR total knee implant
|
NexGen CR
n=155 Participants
Patients who received a NexGen CR total knee implant
|
|---|---|---|
|
Oxford Knee Score - Activity & Participation Questionnaire (APQ)
Preoperative
|
16.4 score on a scale
Standard Deviation 19.7
|
15.2 score on a scale
Standard Deviation 19.4
|
|
Oxford Knee Score - Activity & Participation Questionnaire (APQ)
3 months
|
50.0 score on a scale
Standard Deviation 30.8
|
49.3 score on a scale
Standard Deviation 30.5
|
|
Oxford Knee Score - Activity & Participation Questionnaire (APQ)
1 year
|
71.4 score on a scale
Standard Deviation 30.4
|
64.3 score on a scale
Standard Deviation 31.9
|
|
Oxford Knee Score - Activity & Participation Questionnaire (APQ)
2 years
|
70.5 score on a scale
Standard Deviation 31.2
|
69.4 score on a scale
Standard Deviation 31.0
|
SECONDARY outcome
Timeframe: 3 months, 1 year and 2 years postoperativelyPopulation: 157 patients were enrolled and randomized to each group, but 3 cases were excluded intraoperatively: 2 in the NexGen group and 1 in the Persona group. Additionally, 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 the joint 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 joint awareness, while a total score of 0 indicates the highest level of joint awareness.
Outcome measures
| Measure |
Persona CR
n=156 Participants
Patients who received a Persona CR total knee implant
|
NexGen CR
n=155 Participants
Patients who received a NexGen CR total knee implant
|
|---|---|---|
|
Forgotten Joint Score (FJS)
Preoperative
|
14.3 score on a scale
Standard Error 13.7
|
14.1 score on a scale
Standard Error 13.4
|
|
Forgotten Joint Score (FJS)
3 months
|
42.8 score on a scale
Standard Error 27.8
|
42.6 score on a scale
Standard Error 26.0
|
|
Forgotten Joint Score (FJS)
1 year
|
60.3 score on a scale
Standard Error 27.8
|
56.2 score on a scale
Standard Error 29.2
|
|
Forgotten Joint Score (FJS)
2 years
|
65.0 score on a scale
Standard Error 29.0
|
64.3 score on a scale
Standard Error 27.0
|
SECONDARY outcome
Timeframe: 3 months, 1 year and 2 years postoperativelyPopulation: 157 patients were enrolled and randomized to each group, but 3 cases were excluded intraoperatively: 2 in the NexGen group and 1 in the Persona group. Additionally, some data points are missing due to missed follow-up visits or incomplete form completion
Patients were asked to answer the following satisfaction/anchoring question: "How are your knee problems now, compared to prior to your operation?"
Outcome measures
| Measure |
Persona CR
n=156 Participants
Patients who received a Persona CR total knee implant
|
NexGen CR
n=155 Participants
Patients who received a NexGen CR total knee implant
|
|---|---|---|
|
Patient Satisfaction and Anchoring Questions - Question 1
1 year · About the same
|
0 Participants
|
1 Participants
|
|
Patient Satisfaction and Anchoring Questions - Question 1
3 months · Better, an important improvement
|
109 Participants
|
99 Participants
|
|
Patient Satisfaction and Anchoring Questions - Question 1
3 months · Somewhat better, but enough to be an important improvement
|
31 Participants
|
33 Participants
|
|
Patient Satisfaction and Anchoring Questions - Question 1
3 months · Very small change, not enough to be an important improvement
|
6 Participants
|
7 Participants
|
|
Patient Satisfaction and Anchoring Questions - Question 1
3 months · About the same
|
3 Participants
|
4 Participants
|
|
Patient Satisfaction and Anchoring Questions - Question 1
3 months · Very small change, not enough to be an important worsening
|
2 Participants
|
4 Participants
|
|
Patient Satisfaction and Anchoring Questions - Question 1
3 months · Somewhat worse, but enough to be an important worsening
|
2 Participants
|
3 Participants
|
|
Patient Satisfaction and Anchoring Questions - Question 1
3 months · Worse, an important worsening
|
0 Participants
|
0 Participants
|
|
Patient Satisfaction and Anchoring Questions - Question 1
3 months · Better, an important improvement + About the same
|
1 Participants
|
0 Participants
|
|
Patient Satisfaction and Anchoring Questions - Question 1
3 months · Very small change,not enough to be an important worsening + Somewhat worse
|
0 Participants
|
1 Participants
|
|
Patient Satisfaction and Anchoring Questions - Question 1
1 year · Better, an important improvement
|
123 Participants
|
111 Participants
|
|
Patient Satisfaction and Anchoring Questions - Question 1
1 year · Somewhat better, but enough to be an important improvement
|
16 Participants
|
29 Participants
|
|
Patient Satisfaction and Anchoring Questions - Question 1
1 year · Very small change, not enough to be an important improvement
|
6 Participants
|
2 Participants
|
|
Patient Satisfaction and Anchoring Questions - Question 1
1 year · Very small change, not enough to be an important worsening
|
2 Participants
|
0 Participants
|
|
Patient Satisfaction and Anchoring Questions - Question 1
1 year · Somewhat worse, but enough to be an important worsening
|
1 Participants
|
5 Participants
|
|
Patient Satisfaction and Anchoring Questions - Question 1
1 year · Worse, an important worsening
|
1 Participants
|
3 Participants
|
|
Patient Satisfaction and Anchoring Questions - Question 1
1 year · Better, an important improvement + About the same
|
0 Participants
|
0 Participants
|
|
Patient Satisfaction and Anchoring Questions - Question 1
1 year · Very small change,not enough to be an important worsening + Somewhat worse
|
0 Participants
|
0 Participants
|
|
Patient Satisfaction and Anchoring Questions - Question 1
2 years · Better, an important improvement
|
118 Participants
|
123 Participants
|
|
Patient Satisfaction and Anchoring Questions - Question 1
2 years · Somewhat better, but enough to be an important improvement
|
18 Participants
|
19 Participants
|
|
Patient Satisfaction and Anchoring Questions - Question 1
2 years · Very small change, not enough to be an important improvement
|
3 Participants
|
2 Participants
|
|
Patient Satisfaction and Anchoring Questions - Question 1
2 years · About the same
|
1 Participants
|
0 Participants
|
|
Patient Satisfaction and Anchoring Questions - Question 1
2 years · Very small change, not enough to be an important worsening
|
1 Participants
|
1 Participants
|
|
Patient Satisfaction and Anchoring Questions - Question 1
2 years · Somewhat worse, but enough to be an important worsening
|
1 Participants
|
1 Participants
|
|
Patient Satisfaction and Anchoring Questions - Question 1
2 years · Worse, an important worsening
|
0 Participants
|
1 Participants
|
|
Patient Satisfaction and Anchoring Questions - Question 1
2 years · Better, an important improvement + About the same
|
0 Participants
|
0 Participants
|
|
Patient Satisfaction and Anchoring Questions - Question 1
2 years · Very small change,not enough to be an important worsening + Somewhat worse
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 3 months, 1 year and 2 years postoperativelyPopulation: 157 patients were enrolled and randomized to each group, but 3 cases were excluded intraoperatively: 2 in the NexGen group and 1 in the Persona group. Additionally, some data points are missing due to missed follow-up visits or incomplete form completion
Patients were asked to answer the following satisfaction/anchoring question: "Taking into account all the activities you have during your daily life, your level of pain and functional impairment, do you consider that your current state is satisfactory?"
Outcome measures
| Measure |
Persona CR
n=156 Participants
Patients who received a Persona CR total knee implant
|
NexGen CR
n=155 Participants
Patients who received a NexGen CR total knee implant
|
|---|---|---|
|
Patient Satisfaction and Anchoring Questions - Question 2
3 months · Yes
|
122 Participants
|
119 Participants
|
|
Patient Satisfaction and Anchoring Questions - Question 2
3 months · No
|
32 Participants
|
32 Participants
|
|
Patient Satisfaction and Anchoring Questions - Question 2
1 year · Yes
|
127 Participants
|
132 Participants
|
|
Patient Satisfaction and Anchoring Questions - Question 2
1 year · No
|
22 Participants
|
19 Participants
|
|
Patient Satisfaction and Anchoring Questions - Question 2
2 years · Yes
|
130 Participants
|
137 Participants
|
|
Patient Satisfaction and Anchoring Questions - Question 2
2 years · No
|
12 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: 3 months, 1 year and 2 years postoperativelyPopulation: 157 patients were enrolled and randomized to each group, but 3 cases were excluded intraoperatively: 2 in the NexGen group and 1 in the Persona group. Additionally, some data points are missing due to missed follow-up visits or incomplete form completion
Patients were asked to answer the following satisfaction/anchoring question: "If you answered No, i.e. not satisfied to the result would you consider your current state as being so unsatisfactory that you think the treatment has failed?"
Outcome measures
| Measure |
Persona CR
n=32 Participants
Patients who received a Persona CR total knee implant
|
NexGen CR
n=32 Participants
Patients who received a NexGen CR total knee implant
|
|---|---|---|
|
Patient Satisfaction and Anchoring Questions - Question 3
3 months · Yes
|
5 Participants
|
1 Participants
|
|
Patient Satisfaction and Anchoring Questions - Question 3
3 months · No
|
27 Participants
|
29 Participants
|
|
Patient Satisfaction and Anchoring Questions - Question 3
3 months · No answer provided
|
0 Participants
|
2 Participants
|
|
Patient Satisfaction and Anchoring Questions - Question 3
1 year · Yes
|
4 Participants
|
8 Participants
|
|
Patient Satisfaction and Anchoring Questions - Question 3
1 year · No
|
18 Participants
|
11 Participants
|
|
Patient Satisfaction and Anchoring Questions - Question 3
1 year · No answer provided
|
0 Participants
|
0 Participants
|
|
Patient Satisfaction and Anchoring Questions - Question 3
2 years · Yes
|
4 Participants
|
4 Participants
|
|
Patient Satisfaction and Anchoring Questions - Question 3
2 years · No
|
8 Participants
|
5 Participants
|
|
Patient Satisfaction and Anchoring Questions - Question 3
2 years · No answer provided
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 3 months, 1 year and 2 years postoperativelyPopulation: 157 patients were enrolled and randomized to each group, but 3 cases were excluded intraoperatively: 2 in the NexGen group and 1 in the Persona group. Additionally, some data points are missing due to missed follow-up visits or incomplete form completion
Patients were asked to answer the following satisfaction/anchoring question: "Would you have your knee operated again?"
Outcome measures
| Measure |
Persona CR
n=156 Participants
Patients who received a Persona CR total knee implant
|
NexGen CR
n=155 Participants
Patients who received a NexGen CR total knee implant
|
|---|---|---|
|
Patient Satisfaction and Anchoring Questions - Question 4
3 months · Yes, definitely
|
112 Participants
|
116 Participants
|
|
Patient Satisfaction and Anchoring Questions - Question 4
3 months · Maybe, don't know
|
32 Participants
|
27 Participants
|
|
Patient Satisfaction and Anchoring Questions - Question 4
3 months · No
|
10 Participants
|
8 Participants
|
|
Patient Satisfaction and Anchoring Questions - Question 4
1 year · Yes, definitely
|
121 Participants
|
119 Participants
|
|
Patient Satisfaction and Anchoring Questions - Question 4
1 year · Maybe, don't know
|
25 Participants
|
25 Participants
|
|
Patient Satisfaction and Anchoring Questions - Question 4
1 year · No
|
3 Participants
|
7 Participants
|
|
Patient Satisfaction and Anchoring Questions - Question 4
2 years · Yes, definitely
|
114 Participants
|
114 Participants
|
|
Patient Satisfaction and Anchoring Questions - Question 4
2 years · Maybe, don't know
|
22 Participants
|
23 Participants
|
|
Patient Satisfaction and Anchoring Questions - Question 4
2 years · No
|
6 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: 3 months, 1 year and 2 years postoperativelyPopulation: 157 patients were enrolled and randomized to each group, but 3 cases were excluded intraoperatively: 2 in the NexGen group and 1 in the Persona group. Additionally, 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 questionnaire includes 5 questions referring to mobility, self-care, daily/usual activities, pain/discomfort and anxiety/depression. For EQ-5D-3L, each question can be answered in three ways, indicating no, moderate, or extreme pain. In the derived EQ-5D-3L score, the highest score is 1 and the lowest score is -0.59; negative numbers correspond to a self-assessed health state worse than being dead.
Outcome measures
| Measure |
Persona CR
n=156 Participants
Patients who received a Persona CR total knee implant
|
NexGen CR
n=155 Participants
Patients who received a NexGen CR total knee implant
|
|---|---|---|
|
EuroQol 5D (EQ-5D) Score
Preoperative
|
0.500 score on a scale
Standard Deviation 0.272
|
0.516 score on a scale
Standard Deviation 0.272
|
|
EuroQol 5D (EQ-5D) Score
3 months
|
0.765 score on a scale
Standard Deviation 0.190
|
0.778 score on a scale
Standard Deviation 0.173
|
|
EuroQol 5D (EQ-5D) Score
1 year
|
0.840 score on a scale
Standard Deviation 0.201
|
0.840 score on a scale
Standard Deviation 0.173
|
|
EuroQol 5D (EQ-5D) Score
2 years
|
0.868 score on a scale
Standard Deviation 0.187
|
0.866 score on a scale
Standard Deviation 0.197
|
SECONDARY outcome
Timeframe: Immediate postoperative and 3 months, 1 year and 2 years postoperativelyPopulation: 157 patients were enrolled and randomized to each group, but 3 cases were excluded intraoperatively: 2 in the NexGen group and 1 in the Persona group. Additionally, some data points are missing due to missed follow-up visits or incomplete form completion
All X-rays were sent to an independent radiographer. Postoperative lucency was determined as presence of radiolucent intervals at the cement-bone interface. Femoral lucency and tibial lucency are reported separately.
Outcome measures
| Measure |
Persona CR
n=156 Participants
Patients who received a Persona CR total knee implant
|
NexGen CR
n=155 Participants
Patients who received a NexGen CR total knee implant
|
|---|---|---|
|
Radiolucency / Osteolysis
Immediate postoperative : Tibial lucency
|
0 Participants
|
0 Participants
|
|
Radiolucency / Osteolysis
Immediate postoperative : Femoral lucency
|
1 Participants
|
2 Participants
|
|
Radiolucency / Osteolysis
3 months : Tibial lucency
|
3 Participants
|
9 Participants
|
|
Radiolucency / Osteolysis
3 months : Femoral lucency
|
7 Participants
|
9 Participants
|
|
Radiolucency / Osteolysis
1 year : Tibial lucency
|
6 Participants
|
16 Participants
|
|
Radiolucency / Osteolysis
1 year : Femoral lucency
|
14 Participants
|
22 Participants
|
|
Radiolucency / Osteolysis
2 years : Tibial lucency
|
14 Participants
|
16 Participants
|
|
Radiolucency / Osteolysis
2 years : Femoral lucency
|
21 Participants
|
20 Participants
|
SECONDARY outcome
Timeframe: 5, 7 and 10 years postoperatively.Registry data at 5, 7 and 10 years postoperatively.
Outcome measures
Outcome data not reported
Adverse Events
Persona CR
Serious events: 23 serious events
Other events: 16 other events
Deaths: 1 deaths
NexGen CR
Serious events: 28 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Persona CR
n=156 participants at risk
Patients who received a Persona CR total knee implant, excluding the 1 case excluded intraoperatively.
|
NexGen CR
n=155 participants at risk
Patients who received a NexGen CR total knee implant, excluding the 2 cases excluded intraoperatively.
|
|---|---|---|
|
Hepatobiliary disorders
Gallstone + Pancreatitis
|
0.64%
1/156 • Number of events 1 • From study start up to 2 years post-operatively
Adverse events have been documented continuously by checking with the study patients at every follow-up visit.
|
0.00%
0/155 • From study start up to 2 years post-operatively
Adverse events have been documented continuously by checking with the study patients at every follow-up visit.
|
|
Musculoskeletal and connective tissue disorders
Shoulder Fracture Due to Fall
|
0.64%
1/156 • Number of events 1 • From study start up to 2 years post-operatively
Adverse events have been documented continuously by checking with the study patients at every follow-up visit.
|
0.65%
1/155 • Number of events 1 • From study start up to 2 years post-operatively
Adverse events have been documented continuously by checking with the study patients at every follow-up visit.
|
|
Musculoskeletal and connective tissue disorders
Effusion
|
0.64%
1/156 • Number of events 1 • From study start up to 2 years post-operatively
Adverse events have been documented continuously by checking with the study patients at every follow-up visit.
|
0.00%
0/155 • From study start up to 2 years post-operatively
Adverse events have been documented continuously by checking with the study patients at every follow-up visit.
|
|
Surgical and medical procedures
Shoulder Surgery
|
0.64%
1/156 • Number of events 1 • From study start up to 2 years post-operatively
Adverse events have been documented continuously by checking with the study patients at every follow-up visit.
|
0.00%
0/155 • From study start up to 2 years post-operatively
Adverse events have been documented continuously by checking with the study patients at every follow-up visit.
|
|
Cardiac disorders
Arythmia
|
0.00%
0/156 • From study start up to 2 years post-operatively
Adverse events have been documented continuously by checking with the study patients at every follow-up visit.
|
2.6%
4/155 • Number of events 4 • From study start up to 2 years post-operatively
Adverse events have been documented continuously by checking with the study patients at every follow-up visit.
|
|
Cardiac disorders
Congestive Hearth Failure
|
0.64%
1/156 • Number of events 1 • From study start up to 2 years post-operatively
Adverse events have been documented continuously by checking with the study patients at every follow-up visit.
|
0.00%
0/155 • From study start up to 2 years post-operatively
Adverse events have been documented continuously by checking with the study patients at every follow-up visit.
|
|
Cardiac disorders
Myocardial Infarction
|
0.00%
0/156 • From study start up to 2 years post-operatively
Adverse events have been documented continuously by checking with the study patients at every follow-up visit.
|
0.65%
1/155 • Number of events 1 • From study start up to 2 years post-operatively
Adverse events have been documented continuously by checking with the study patients at every follow-up visit.
|
|
Endocrine disorders
Pancreatitis
|
0.00%
0/156 • From study start up to 2 years post-operatively
Adverse events have been documented continuously by checking with the study patients at every follow-up visit.
|
0.65%
1/155 • Number of events 1 • From study start up to 2 years post-operatively
Adverse events have been documented continuously by checking with the study patients at every follow-up visit.
|
|
Gastrointestinal disorders
Infection (non-knee)
|
0.00%
0/156 • From study start up to 2 years post-operatively
Adverse events have been documented continuously by checking with the study patients at every follow-up visit.
|
1.3%
2/155 • Number of events 2 • From study start up to 2 years 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%
0/156 • From study start up to 2 years post-operatively
Adverse events have been documented continuously by checking with the study patients at every follow-up visit.
|
1.3%
2/155 • Number of events 2 • From study start up to 2 years 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 Due to Fall
|
0.64%
1/156 • Number of events 1 • From study start up to 2 years post-operatively
Adverse events have been documented continuously by checking with the study patients at every follow-up visit.
|
0.00%
0/155 • From study start up to 2 years 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 Stiffness
|
0.00%
0/156 • From study start up to 2 years post-operatively
Adverse events have been documented continuously by checking with the study patients at every follow-up visit.
|
1.9%
3/155 • Number of events 3 • From study start up to 2 years post-operatively
Adverse events have been documented continuously by checking with the study patients at every follow-up visit.
|
|
Musculoskeletal and connective tissue disorders
Patella Fracture
|
0.00%
0/156 • From study start up to 2 years post-operatively
Adverse events have been documented continuously by checking with the study patients at every follow-up visit.
|
0.65%
1/155 • Number of events 1 • From study start up to 2 years post-operatively
Adverse events have been documented continuously by checking with the study patients at every follow-up visit.
|
|
Musculoskeletal and connective tissue disorders
Patella Pain
|
0.64%
1/156 • Number of events 1 • From study start up to 2 years post-operatively
Adverse events have been documented continuously by checking with the study patients at every follow-up visit.
|
0.00%
0/155 • From study start up to 2 years post-operatively
Adverse events have been documented continuously by checking with the study patients at every follow-up visit.
|
|
Musculoskeletal and connective tissue disorders
Trochanteric Bursitis
|
0.00%
0/156 • From study start up to 2 years post-operatively
Adverse events have been documented continuously by checking with the study patients at every follow-up visit.
|
0.65%
1/155 • Number of events 1 • From study start up to 2 years post-operatively
Adverse events have been documented continuously by checking with the study patients at every follow-up visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer
|
1.3%
2/156 • Number of events 2 • From study start up to 2 years post-operatively
Adverse events have been documented continuously by checking with the study patients at every follow-up visit.
|
1.9%
3/155 • Number of events 3 • From study start up to 2 years post-operatively
Adverse events have been documented continuously by checking with the study patients at every follow-up visit.
|
|
Nervous system disorders
Nerve Injury
|
0.64%
1/156 • Number of events 1 • From study start up to 2 years post-operatively
Adverse events have been documented continuously by checking with the study patients at every follow-up visit.
|
0.00%
0/155 • From study start up to 2 years post-operatively
Adverse events have been documented continuously by checking with the study patients at every follow-up visit.
|
|
Nervous system disorders
Stroke
|
0.00%
0/156 • From study start up to 2 years post-operatively
Adverse events have been documented continuously by checking with the study patients at every follow-up visit.
|
0.65%
1/155 • Number of events 1 • From study start up to 2 years post-operatively
Adverse events have been documented continuously by checking with the study patients at every follow-up visit.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Infection
|
1.3%
2/156 • Number of events 2 • From study start up to 2 years post-operatively
Adverse events have been documented continuously by checking with the study patients at every follow-up visit.
|
0.00%
0/155 • From study start up to 2 years post-operatively
Adverse events have been documented continuously by checking with the study patients at every follow-up visit.
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of Breath/Dyspnea
|
0.00%
0/156 • From study start up to 2 years post-operatively
Adverse events have been documented continuously by checking with the study patients at every follow-up visit.
|
1.3%
2/155 • Number of events 2 • From study start up to 2 years post-operatively
Adverse events have been documented continuously by checking with the study patients at every follow-up visit.
|
|
Surgical and medical procedures
Bowel Rupture
|
0.00%
0/156 • From study start up to 2 years post-operatively
Adverse events have been documented continuously by checking with the study patients at every follow-up visit.
|
0.65%
1/155 • Number of events 1 • From study start up to 2 years 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
|
1.9%
3/156 • Number of events 3 • From study start up to 2 years post-operatively
Adverse events have been documented continuously by checking with the study patients at every follow-up visit.
|
3.2%
5/155 • Number of events 5 • From study start up to 2 years post-operatively
Adverse events have been documented continuously by checking with the study patients at every follow-up visit.
|
|
Surgical and medical procedures
Foot Surgery
|
0.64%
1/156 • Number of events 1 • From study start up to 2 years post-operatively
Adverse events have been documented continuously by checking with the study patients at every follow-up visit.
|
0.65%
1/155 • Number of events 1 • From study start up to 2 years 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
|
0.64%
1/156 • Number of events 1 • From study start up to 2 years post-operatively
Adverse events have been documented continuously by checking with the study patients at every follow-up visit.
|
0.00%
0/155 • From study start up to 2 years post-operatively
Adverse events have been documented continuously by checking with the study patients at every follow-up visit.
|
|
Surgical and medical procedures
Hip Surgery
|
0.64%
1/156 • Number of events 1 • From study start up to 2 years post-operatively
Adverse events have been documented continuously by checking with the study patients at every follow-up visit.
|
0.65%
1/155 • Number of events 1 • From study start up to 2 years post-operatively
Adverse events have been documented continuously by checking with the study patients at every follow-up visit.
|
|
Surgical and medical procedures
Spinal Stenosis
|
0.00%
0/156 • From study start up to 2 years post-operatively
Adverse events have been documented continuously by checking with the study patients at every follow-up visit.
|
0.65%
1/155 • Number of events 1 • From study start up to 2 years post-operatively
Adverse events have been documented continuously by checking with the study patients at every follow-up visit.
|
|
Vascular disorders
Deep Vein Thrombosis
|
0.00%
0/156 • From study start up to 2 years post-operatively
Adverse events have been documented continuously by checking with the study patients at every follow-up visit.
|
0.65%
1/155 • Number of events 1 • From study start up to 2 years post-operatively
Adverse events have been documented continuously by checking with the study patients at every follow-up visit.
|
|
Nervous system disorders
Cerebral Aneurysma
|
0.64%
1/156 • Number of events 1 • From study start up to 2 years post-operatively
Adverse events have been documented continuously by checking with the study patients at every follow-up visit.
|
0.00%
0/155 • From study start up to 2 years post-operatively
Adverse events have been documented continuously by checking with the study patients at every follow-up visit.
|
|
Infections and infestations
Hypoglycemia + Influenza
|
0.00%
0/156 • From study start up to 2 years post-operatively
Adverse events have been documented continuously by checking with the study patients at every follow-up visit.
|
0.65%
1/155 • Number of events 1 • From study start up to 2 years post-operatively
Adverse events have been documented continuously by checking with the study patients at every follow-up visit.
|
|
Surgical and medical procedures
Revision Contralateral Knee
|
0.00%
0/156 • From study start up to 2 years post-operatively
Adverse events have been documented continuously by checking with the study patients at every follow-up visit.
|
0.65%
1/155 • Number of events 1 • From study start up to 2 years post-operatively
Adverse events have been documented continuously by checking with the study patients at every follow-up visit.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.64%
1/156 • Number of events 1 • From study start up to 2 years post-operatively
Adverse events have been documented continuously by checking with the study patients at every follow-up visit.
|
0.00%
0/155 • From study start up to 2 years post-operatively
Adverse events have been documented continuously by checking with the study patients at every follow-up visit.
|
|
Surgical and medical procedures
Tibial Base Plate Loosening
|
0.00%
0/156 • From study start up to 2 years post-operatively
Adverse events have been documented continuously by checking with the study patients at every follow-up visit.
|
0.65%
1/155 • Number of events 1 • From study start up to 2 years 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)
|
0.00%
0/156 • From study start up to 2 years post-operatively
Adverse events have been documented continuously by checking with the study patients at every follow-up visit.
|
0.65%
1/155 • Number of events 1 • From study start up to 2 years post-operatively
Adverse events have been documented continuously by checking with the study patients at every follow-up visit.
|
|
Surgical and medical procedures
Dislocated Liner
|
0.64%
1/156 • Number of events 1 • From study start up to 2 years post-operatively
Adverse events have been documented continuously by checking with the study patients at every follow-up visit.
|
0.00%
0/155 • From study start up to 2 years post-operatively
Adverse events have been documented continuously by checking with the study patients at every follow-up visit.
|
|
Surgical and medical procedures
Knee Instability
|
1.3%
2/156 • Number of events 2 • From study start up to 2 years post-operatively
Adverse events have been documented continuously by checking with the study patients at every follow-up visit.
|
0.00%
0/155 • From study start up to 2 years post-operatively
Adverse events have been documented continuously by checking with the study patients at every follow-up visit.
|
|
Surgical and medical procedures
Flexion Contracture
|
0.64%
1/156 • Number of events 1 • From study start up to 2 years post-operatively
Adverse events have been documented continuously by checking with the study patients at every follow-up visit.
|
0.00%
0/155 • From study start up to 2 years post-operatively
Adverse events have been documented continuously by checking with the study patients at every follow-up visit.
|
Other adverse events
| Measure |
Persona CR
n=156 participants at risk
Patients who received a Persona CR total knee implant, excluding the 1 case excluded intraoperatively.
|
NexGen CR
n=155 participants at risk
Patients who received a NexGen CR total knee implant, excluding the 2 cases excluded intraoperatively.
|
|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer Diagnosis
|
0.64%
1/156 • Number of events 1 • From study start up to 2 years post-operatively
Adverse events have been documented continuously by checking with the study patients at every follow-up visit.
|
0.65%
1/155 • Number of events 1 • From study start up to 2 years 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
|
0.00%
0/156 • From study start up to 2 years post-operatively
Adverse events have been documented continuously by checking with the study patients at every follow-up visit.
|
2.6%
4/155 • Number of events 4 • From study start up to 2 years post-operatively
Adverse events have been documented continuously by checking with the study patients at every follow-up visit.
|
|
Skin and subcutaneous tissue disorders
Delayed Wound Healing
|
0.64%
1/156 • Number of events 1 • From study start up to 2 years post-operatively
Adverse events have been documented continuously by checking with the study patients at every follow-up visit.
|
1.3%
2/155 • Number of events 2 • From study start up to 2 years 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
|
0.64%
1/156 • Number of events 1 • From study start up to 2 years post-operatively
Adverse events have been documented continuously by checking with the study patients at every follow-up visit.
|
1.3%
2/155 • Number of events 2 • From study start up to 2 years post-operatively
Adverse events have been documented continuously by checking with the study patients at every follow-up visit.
|
|
Musculoskeletal and connective tissue disorders
Flexion Contracture
|
0.64%
1/156 • Number of events 1 • From study start up to 2 years post-operatively
Adverse events have been documented continuously by checking with the study patients at every follow-up visit.
|
0.65%
1/155 • Number of events 1 • From study start up to 2 years 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
|
3.8%
6/156 • Number of events 6 • From study start up to 2 years post-operatively
Adverse events have been documented continuously by checking with the study patients at every follow-up visit.
|
5.8%
9/155 • Number of events 9 • From study start up to 2 years 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 Due to Fall
|
1.3%
2/156 • Number of events 2 • From study start up to 2 years post-operatively
Adverse events have been documented continuously by checking with the study patients at every follow-up visit.
|
0.00%
0/155 • From study start up to 2 years 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 Swelling
|
1.3%
2/156 • Number of events 2 • From study start up to 2 years post-operatively
Adverse events have been documented continuously by checking with the study patients at every follow-up visit.
|
1.3%
2/155 • Number of events 2 • From study start up to 2 years 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 Stiffness
|
1.3%
2/156 • Number of events 2 • From study start up to 2 years post-operatively
Adverse events have been documented continuously by checking with the study patients at every follow-up visit.
|
0.65%
1/155 • Number of events 1 • From study start up to 2 years 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