Trial Outcomes & Findings for Evaluate the Performance of JOURNEY II CR in TKA Populations (NCT NCT04818840)
NCT ID: NCT04818840
Last Updated: 2025-08-20
Results Overview
The Oxford Knee Score (OKS) is a Patient Reported Outcome questionnaire that was developed to specifically assess the patient's perspective of outcome following Total Knee Arthroplasty (TKA). The OKS is a patient self-completion PRO containing 12 equally weighted questions on activities of daily living. The OKS has been developed and validated specifically to assess perceived function and pain answered on a Likert scale after TKA. Responses to each question ranges from 0-4 with a range of a possible overall score from 0-48. A score of 0 is the worst possible outcome while a score of 48 is the best possible outcome.
TERMINATED
62 participants
2 years
2025-08-20
Participant Flow
There were 62 participants in total enrolled into the study across 5 study sites. The 60 participants that received the study device were included in the analysis. Two participants were excluded before assignment to groups because they did not receive the study device.
Participant milestones
| Measure |
Resurfaced/Non Patella
Undergoing Total Knee Replacement with JOURNEY II CR Total Knee System
Resurfaced Patella: JOURNEY II CR Total Knee System was used for Total Knee replacement
|
Un-resurfaced Patella
Undergoing Total Knee Replacement with JOURNEY II CR Total Knee System
Un-resurfaced Patella: JOURNEY II CR Total Knee System was used for Total Knee replacement
|
|---|---|---|
|
Overall Study
STARTED
|
44
|
16
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
44
|
16
|
Reasons for withdrawal
| Measure |
Resurfaced/Non Patella
Undergoing Total Knee Replacement with JOURNEY II CR Total Knee System
Resurfaced Patella: JOURNEY II CR Total Knee System was used for Total Knee replacement
|
Un-resurfaced Patella
Undergoing Total Knee Replacement with JOURNEY II CR Total Knee System
Un-resurfaced Patella: JOURNEY II CR Total Knee System was used for Total Knee replacement
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
5
|
|
Overall Study
Physician Decision
|
1
|
0
|
|
Overall Study
Site Terminated by Sponsor
|
0
|
3
|
|
Overall Study
Study Terminated by Sponsor
|
43
|
7
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Evaluate the Performance of JOURNEY II CR in TKA Populations
Baseline characteristics by cohort
| Measure |
Resurfaced/Non Patella
n=44 Participants
Undergoing Total Knee Replacement with JOURNEY II CR Total Knee System
Resurfaced Patella: JOURNEY II CR Total Knee System was used for Total Knee replacement
|
Un-resurfaced Patella
n=16 Participants
Undergoing Total Knee Replacement with JOURNEY II CR Total Knee System
Un-resurfaced Patella: JOURNEY II CR Total Knee System was used for Total Knee replacement
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
34 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
46 Participants
n=206 Participants
|
|
Age, Continuous
|
69.8 years
STANDARD_DEVIATION 8.0 • n=99 Participants
|
68.0 years
STANDARD_DEVIATION 6.8 • n=107 Participants
|
69.4 years
STANDARD_DEVIATION 7.7 • n=206 Participants
|
|
Sex: Female, Male
Female
|
34 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
45 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
44 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
60 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
Singapore
|
0 participants
n=99 Participants
|
3 participants
n=107 Participants
|
3 participants
n=206 Participants
|
|
Region of Enrollment
Japan
|
43 participants
n=99 Participants
|
0 participants
n=107 Participants
|
43 participants
n=206 Participants
|
|
Region of Enrollment
China
|
0 participants
n=99 Participants
|
10 participants
n=107 Participants
|
10 participants
n=206 Participants
|
|
Region of Enrollment
Hong Kong
|
1 participants
n=99 Participants
|
3 participants
n=107 Participants
|
4 participants
n=206 Participants
|
|
Height
|
155.7 centimeters (cm)
STANDARD_DEVIATION 7.6 • n=99 Participants
|
157.6 centimeters (cm)
STANDARD_DEVIATION 9.5 • n=107 Participants
|
156.2 centimeters (cm)
STANDARD_DEVIATION 8.1 • n=206 Participants
|
|
Weight
|
67.5 kilograms (kg)
STANDARD_DEVIATION 15.5 • n=99 Participants
|
67.4 kilograms (kg)
STANDARD_DEVIATION 8.7 • n=107 Participants
|
67.5 kilograms (kg)
STANDARD_DEVIATION 13.9 • n=206 Participants
|
|
Body Mass Index (BMI)
|
27.6 kg/m^2
STANDARD_DEVIATION 4.6 • n=99 Participants
|
27.2 kg/m^2
STANDARD_DEVIATION 2.8 • n=107 Participants
|
27.5 kg/m^2
STANDARD_DEVIATION 4.2 • n=206 Participants
|
|
Operative Diagnosis
Osteoarthritis
|
43 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
59 Participants
n=206 Participants
|
|
Operative Diagnosis
Avascular necrosis
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Operative Diagnosis
Functional deformity
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Operative Diagnosis
Fractures that were unmanageable using other techniques
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Operative Diagnosis
Missing
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 2 yearsPopulation: Data not collected for outcome because no participant reached the 2 year time frame due to early termination of the study. While the general study duration does cover 2 years, there were multiple sites. No participant at any site reached the 2 year time point because the study was terminated before any of the data was collected for this visit.
The Oxford Knee Score (OKS) is a Patient Reported Outcome questionnaire that was developed to specifically assess the patient's perspective of outcome following Total Knee Arthroplasty (TKA). The OKS is a patient self-completion PRO containing 12 equally weighted questions on activities of daily living. The OKS has been developed and validated specifically to assess perceived function and pain answered on a Likert scale after TKA. Responses to each question ranges from 0-4 with a range of a possible overall score from 0-48. A score of 0 is the worst possible outcome while a score of 48 is the best possible outcome.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 months, 1 year, 2 years, 3 yearsPopulation: Participants that received the study device with data collected for the outcome and time frame indicated. Data not collected for all time points due to early termination of the study. While the general study duration does cover 2 years, there were multiple sites. No participant at any site reached the 2 year time point because the study was terminated before any of the data was collected for any visit on or after the 2 year visit.
The Forgotten Joint Score (FJS) comprises measures for the assessment of joint-specific patient reported outcomes. This questionnaire focuses on the study participant's awareness of the partially or fully replaced knee joint in everyday life. Joint awareness can be simply defined as any unintended perception of a joint. Participants are asked to rate their awareness of their knee arthroplasty in 12 questions with a five-point Likert response format: "Never", "almost never", "seldom", "sometimes" and "mostly". The item scores are summed and linearly transformed in a 0 to 100 scale with a high value reflecting the ability of the subject to forget about the replaced knee joint during the activities of daily living (i.e., a higher score is a better outcome).
Outcome measures
| Measure |
Resurfaced/Non Patella
n=27 Participants
Undergoing Total Knee Replacement with JOURNEY II CR Total Knee System
Resurfaced Patella: JOURNEY II CR Total Knee System was used for Total Knee replacement
|
Un-resurfaced Patella
n=9 Participants
Undergoing Total Knee Replacement with JOURNEY II CR Total Knee System
Un-resurfaced Patella: JOURNEY II CR Total Knee System was used for Total Knee replacement
|
|---|---|---|
|
Forgotten Joint Score (FJS)
6 months
|
40.8 score on a scale
Standard Deviation 22.2
|
72.2 score on a scale
Standard Deviation 30.4
|
|
Forgotten Joint Score (FJS)
1 year
|
49.0 score on a scale
Standard Deviation 28.6
|
89.6 score on a scale
Standard Deviation 20.8
|
SECONDARY outcome
Timeframe: Pre-Operative, 6 months, 1 year, 3 yearsPopulation: Participants that received the study device with data collected for the outcome and time frame indicated. Data not collected for all time points due to early termination of the study. While the general study duration does cover 2 years, there were multiple sites. No participant at any site reached the 2 year time point because the study was terminated before any of the data was collected for any visit on or after the 2 year visit.
The Oxford Knee Score (OKS) is a Patient Reported Outcome (PRO) questionnaire that was developed to specifically assess the patient's perspective of outcome following Total Knee Arthroplasty (TKA). The OKS is a patient self-completion PRO containing 12 equally weighted questions on activities of daily living. The OKS has been developed and validated specifically to assess perceived function and pain answered on a Likert scale after TKA. Overall scores range from 0 to 48, where a score of 0 is the worst possible outcome and a score of 48 is the best possible outcome.
Outcome measures
| Measure |
Resurfaced/Non Patella
n=42 Participants
Undergoing Total Knee Replacement with JOURNEY II CR Total Knee System
Resurfaced Patella: JOURNEY II CR Total Knee System was used for Total Knee replacement
|
Un-resurfaced Patella
n=16 Participants
Undergoing Total Knee Replacement with JOURNEY II CR Total Knee System
Un-resurfaced Patella: JOURNEY II CR Total Knee System was used for Total Knee replacement
|
|---|---|---|
|
Oxford Knee Score (OKS)
6 months
|
35.2 score on a scale
Standard Deviation 8.2
|
37.3 score on a scale
Standard Deviation 10.0
|
|
Oxford Knee Score (OKS)
Pre-Operative
|
21.0 score on a scale
Standard Deviation 9.1
|
22.9 score on a scale
Standard Deviation 7.8
|
|
Oxford Knee Score (OKS)
1 year
|
38.0 score on a scale
Standard Deviation 7.6
|
44.5 score on a scale
Standard Deviation 4.4
|
SECONDARY outcome
Timeframe: Pre-Operative, 6 months, 1 year, 2 years, 3 yearsPopulation: Participants that received the study device with data collected for the outcome and time frame indicated. Data not collected for all time points due to early termination of the study. While the general study duration does cover 2 years, there were multiple sites. No participant at any site reached the 2 year time point because the study was terminated before any of the data was collected for any visit on or after the 2 year visit.
The KSS is a validated tool that combines an objective physician-derived component with a subjective subject-derived component and consists of 4 separate sub-scales: The "Objective" Knee Score sub-scale is assessed by the surgeon, focusing on clinical measures such as pain, range of motion, and stability. The score is 7 items on a scale of 0 to 100 where a higher score indicates a better outcome.
Outcome measures
| Measure |
Resurfaced/Non Patella
n=42 Participants
Undergoing Total Knee Replacement with JOURNEY II CR Total Knee System
Resurfaced Patella: JOURNEY II CR Total Knee System was used for Total Knee replacement
|
Un-resurfaced Patella
n=5 Participants
Undergoing Total Knee Replacement with JOURNEY II CR Total Knee System
Un-resurfaced Patella: JOURNEY II CR Total Knee System was used for Total Knee replacement
|
|---|---|---|
|
Knee Society Score (KSS): "Objective" Knee Score
Pre-Operative
|
23.6 score on a scale
Standard Deviation 20.6
|
28.6 score on a scale
Standard Deviation 12.3
|
|
Knee Society Score (KSS): "Objective" Knee Score
6 months
|
70.0 score on a scale
Standard Deviation 7.4
|
68.7 score on a scale
Standard Deviation 8.0
|
|
Knee Society Score (KSS): "Objective" Knee Score
1 year
|
72.5 score on a scale
Standard Deviation 7.3
|
—
|
SECONDARY outcome
Timeframe: Pre-Operative, 6 months, 1 year, 2 years, 3 yearsPopulation: Participants that received the study device with data collected for the outcome and time frame indicated. Data not collected for all time points due to early termination of the study. While the general study duration does cover 2 years, there were multiple sites. No participant at any site reached the 2 year time point because the study was terminated before any of the data was collected for any visit on or after the 2 year visit.
The KSS is a validated tool that combines an objective physician-derived component with a subjective subject-derived component and consists of 4 separate sub-scales. The Patient Satisfaction sub-scale score evaluates the participant's satisfaction with their knee function and pain relief. The score is five items on a scale of 0 to 40 where a higher score indicates a better outcome.
Outcome measures
| Measure |
Resurfaced/Non Patella
n=42 Participants
Undergoing Total Knee Replacement with JOURNEY II CR Total Knee System
Resurfaced Patella: JOURNEY II CR Total Knee System was used for Total Knee replacement
|
Un-resurfaced Patella
n=16 Participants
Undergoing Total Knee Replacement with JOURNEY II CR Total Knee System
Un-resurfaced Patella: JOURNEY II CR Total Knee System was used for Total Knee replacement
|
|---|---|---|
|
Knee Society Score (KSS): Patient Satisfaction Score
Pre-Operative
|
11.7 score on a scale
Standard Deviation 7.5
|
11.4 score on a scale
Standard Deviation 9.2
|
|
Knee Society Score (KSS): Patient Satisfaction Score
6 months
|
22.7 score on a scale
Standard Deviation 8.1
|
28.9 score on a scale
Standard Deviation 4.9
|
|
Knee Society Score (KSS): Patient Satisfaction Score
1 year
|
28.0 score on a scale
Standard Deviation 8.5
|
31.0 score on a scale
Standard Deviation 6.6
|
SECONDARY outcome
Timeframe: Pre-Operative, 6 months, 1 year, 2 years, 3 yearsPopulation: Participants that received the study device with data collected for the outcome and time frame indicated. Data not collected for all time points due to early termination of the study. While the general study duration does cover 2 years, there were multiple sites. No participant at any site reached the 2 year time point because the study was terminated before any of the data was collected for any visit on or after the 2 year visit.
The KSS is a validated tool that combines an objective physician-derived component with a subjective subject-derived component and consists of 4 separate sub-scales. The Patient Expectation sub-scale score assesses the participant's expectations regarding their knee function and outcomes. The score is three items on a scale of 3 to 15 where a higher score indicates a better outcome.
Outcome measures
| Measure |
Resurfaced/Non Patella
n=42 Participants
Undergoing Total Knee Replacement with JOURNEY II CR Total Knee System
Resurfaced Patella: JOURNEY II CR Total Knee System was used for Total Knee replacement
|
Un-resurfaced Patella
n=16 Participants
Undergoing Total Knee Replacement with JOURNEY II CR Total Knee System
Un-resurfaced Patella: JOURNEY II CR Total Knee System was used for Total Knee replacement
|
|---|---|---|
|
Knee Society Score (KSS): Patient Expectation Score
Pre-Operative
|
13.8 score on a scale
Standard Deviation 1.5
|
14.4 score on a scale
Standard Deviation 2.0
|
|
Knee Society Score (KSS): Patient Expectation Score
6 months
|
9.0 score on a scale
Standard Deviation 3.0
|
11.0 score on a scale
Standard Deviation 3.1
|
|
Knee Society Score (KSS): Patient Expectation Score
1 year
|
9.7 score on a scale
Standard Deviation 2.9
|
10.3 score on a scale
Standard Deviation 2.5
|
SECONDARY outcome
Timeframe: Pre-Operative, 6 months, 1 year, 2 years, 3 yearsPopulation: Participants that received the study device with data collected for the outcome and time frame indicated. Data not collected for all time points due to early termination of the study. While the general study duration does cover 2 years, there were multiple sites. No participant at any site reached the 2 year time point because the study was terminated before any of the data was collected for any visit on or after the 2 year visit.
The KSS is a validated tool that combines an objective physician-derived component with a subjective subject-derived component and consists of 4 separate sub-scales. The Functional Knee Score is derived from assessments of walking and standing, standard activities, advanced activities, and discretionary activities to evaluate the participant's ability to perform daily activities and their overall functional capabilities. The score is 19 items on a scale of 0 to 100 where a higher score indicates a better outcome.
Outcome measures
| Measure |
Resurfaced/Non Patella
n=17 Participants
Undergoing Total Knee Replacement with JOURNEY II CR Total Knee System
Resurfaced Patella: JOURNEY II CR Total Knee System was used for Total Knee replacement
|
Un-resurfaced Patella
n=6 Participants
Undergoing Total Knee Replacement with JOURNEY II CR Total Knee System
Un-resurfaced Patella: JOURNEY II CR Total Knee System was used for Total Knee replacement
|
|---|---|---|
|
Knee Society Score (KSS): Functional Knee Score
Pre-Operative
|
47.8 score on a scale
Standard Deviation 20.0
|
47.2 score on a scale
Standard Deviation 15.1
|
|
Knee Society Score (KSS): Functional Knee Score
6 months
|
80.4 score on a scale
Standard Deviation 7.2
|
86.2 score on a scale
Standard Deviation 14.5
|
|
Knee Society Score (KSS): Functional Knee Score
1 year
|
83.8 score on a scale
Standard Deviation 21.0
|
89.8 score on a scale
Standard Deviation 11.5
|
SECONDARY outcome
Timeframe: Pre-OperativePopulation: Participants that received the study device with data collected for the outcome and time frame indicated.
Patient expectation measured by asking participants to select "ONE activity that matters to you most and you expect to participate after the surgery?" Responses were categorized as: 1. Regularly participate in impact sports (e.g., jogging, tennis, skiing, acrobatics, ballet, heavy labor, backpacking, basketball, mountain climbing or badminton with running \& jumping) 2. Sometime participate in impact sports 3. Regularly participate in very active events (e.g., bowling, golf, table tennis, badminton without running \& jumping or fitness walking) 4. Regularly participate in active events (e.g., bicycling or square dancing) 5. Regularly participate in moderate activities (e.g., swimming \& unlimited housework, shopping or Tai Chi) 6. Sometimes participate in moderate activities 7. Regularly participate in mild activities (e.g., walking, limited housework, \& limited shopping) 8. Sometimes participate in mild activities 9. Restricted to minimal activities of daily living 10. Missing
Outcome measures
| Measure |
Resurfaced/Non Patella
n=44 Participants
Undergoing Total Knee Replacement with JOURNEY II CR Total Knee System
Resurfaced Patella: JOURNEY II CR Total Knee System was used for Total Knee replacement
|
Un-resurfaced Patella
n=16 Participants
Undergoing Total Knee Replacement with JOURNEY II CR Total Knee System
Un-resurfaced Patella: JOURNEY II CR Total Knee System was used for Total Knee replacement
|
|---|---|---|
|
Patient Expectation
Regularly participate in impact sports
|
5 Participants
|
1 Participants
|
|
Patient Expectation
Sometime participate in impact sports
|
0 Participants
|
1 Participants
|
|
Patient Expectation
Regularly participate in very active events
|
4 Participants
|
0 Participants
|
|
Patient Expectation
Regularly participate in active events
|
0 Participants
|
4 Participants
|
|
Patient Expectation
Regularly participate in moderate activities
|
14 Participants
|
5 Participants
|
|
Patient Expectation
Sometimes participate in moderate activities
|
2 Participants
|
0 Participants
|
|
Patient Expectation
Regularly participate in mild activities
|
8 Participants
|
5 Participants
|
|
Patient Expectation
Sometimes participate in mild activities
|
1 Participants
|
0 Participants
|
|
Patient Expectation
Restricted to minimal activities of daily living
|
1 Participants
|
0 Participants
|
|
Patient Expectation
Missing
|
9 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 6 months, 1 year, 2 years, 3 yearsPopulation: Participants that received the study device with data collected for the outcome and time frame indicated. Data not collected for all time points due to early termination of the study. While the general study duration does cover 2 years, there were multiple sites. No participant at any site reached the 2 year time point because the study was terminated before any of the data was collected for any visit on or after the 2 year visit.
Patient satisfaction is measured by a corresponding question based on their expectation asking, "How satisfied are you with the surgery meeting your expectation?" Responses were categorized as: * Very Satisfied * Satisfied * Neutral * Dissatisfied * Very Dissatisfied * Missing
Outcome measures
| Measure |
Resurfaced/Non Patella
n=34 Participants
Undergoing Total Knee Replacement with JOURNEY II CR Total Knee System
Resurfaced Patella: JOURNEY II CR Total Knee System was used for Total Knee replacement
|
Un-resurfaced Patella
n=9 Participants
Undergoing Total Knee Replacement with JOURNEY II CR Total Knee System
Un-resurfaced Patella: JOURNEY II CR Total Knee System was used for Total Knee replacement
|
|---|---|---|
|
Patient Satisfaction
6 months · Very Satisfied
|
4 Participants
|
3 Participants
|
|
Patient Satisfaction
6 months · Satisfied
|
12 Participants
|
3 Participants
|
|
Patient Satisfaction
6 months · Neutral
|
5 Participants
|
3 Participants
|
|
Patient Satisfaction
6 months · Dissatisfied
|
1 Participants
|
0 Participants
|
|
Patient Satisfaction
6 months · Very Dissatisfied
|
0 Participants
|
0 Participants
|
|
Patient Satisfaction
6 months · Missing
|
12 Participants
|
0 Participants
|
|
Patient Satisfaction
1 year · Very Satisfied
|
5 Participants
|
1 Participants
|
|
Patient Satisfaction
1 year · Satisfied
|
10 Participants
|
3 Participants
|
|
Patient Satisfaction
1 year · Neutral
|
4 Participants
|
0 Participants
|
|
Patient Satisfaction
1 year · Dissatisfied
|
1 Participants
|
0 Participants
|
|
Patient Satisfaction
1 year · Very Dissatisfied
|
1 Participants
|
0 Participants
|
|
Patient Satisfaction
1 year · Missing
|
6 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Immediate Post-op to 6 weeks, 6 months, 1 year, 2 yearsPopulation: Participants that received the study device with data collected for the outcome and time frame indicated. Data not collected for all time points due to early termination of the study. While the general study duration does cover 2 years, there were multiple sites. No participant at any site reached the 2 year time point because the study was terminated before any of the data was collected for any visit on or after the 2 year visit.
Standard radiographic evaluation on antero-posterior (A/P) and lateral views performed to identify the number of participants with the presence of radiographic findings categorized as: * Yes * No * Missing
Outcome measures
| Measure |
Resurfaced/Non Patella
n=43 Participants
Undergoing Total Knee Replacement with JOURNEY II CR Total Knee System
Resurfaced Patella: JOURNEY II CR Total Knee System was used for Total Knee replacement
|
Un-resurfaced Patella
n=16 Participants
Undergoing Total Knee Replacement with JOURNEY II CR Total Knee System
Un-resurfaced Patella: JOURNEY II CR Total Knee System was used for Total Knee replacement
|
|---|---|---|
|
Radiographic Assessment: Presence of Radiographic Findings
Immediate Post-Op to 6 weeks · Yes
|
0 Participants
|
10 Participants
|
|
Radiographic Assessment: Presence of Radiographic Findings
Immediate Post-Op to 6 weeks · No
|
43 Participants
|
6 Participants
|
|
Radiographic Assessment: Presence of Radiographic Findings
Immediate Post-Op to 6 weeks · Missing
|
0 Participants
|
0 Participants
|
|
Radiographic Assessment: Presence of Radiographic Findings
6 months · Yes
|
1 Participants
|
6 Participants
|
|
Radiographic Assessment: Presence of Radiographic Findings
6 months · No
|
33 Participants
|
3 Participants
|
|
Radiographic Assessment: Presence of Radiographic Findings
6 months · Missing
|
3 Participants
|
0 Participants
|
|
Radiographic Assessment: Presence of Radiographic Findings
1 year · Yes
|
0 Participants
|
3 Participants
|
|
Radiographic Assessment: Presence of Radiographic Findings
1 year · No
|
25 Participants
|
1 Participants
|
|
Radiographic Assessment: Presence of Radiographic Findings
1 year · Missing
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Immediate Post-op to 6 weeks, 6 months, 1 year, 2 yearsPopulation: Participants that received the study device with data collected for the outcome and time frame indicated. While general study duration covers 2 years, there were multiple sites with no participant reaching the 2 year visit for data collection due to study termination. Responses from a site indicated radiographic findings for participants in the un-resurfaced patella group (i.e., "Yes" to presence of radiographic findings), but 'No' indicated for Aseptic Loosening radiographic finding option.
Standard radiographic evaluation on antero-posterior (A/P) and lateral views performed to identify the radiographic finding type by the presence of aseptic loosening as one of the following: * Yes * No * Missing
Outcome measures
| Measure |
Resurfaced/Non Patella
n=43 Participants
Undergoing Total Knee Replacement with JOURNEY II CR Total Knee System
Resurfaced Patella: JOURNEY II CR Total Knee System was used for Total Knee replacement
|
Un-resurfaced Patella
n=16 Participants
Undergoing Total Knee Replacement with JOURNEY II CR Total Knee System
Un-resurfaced Patella: JOURNEY II CR Total Knee System was used for Total Knee replacement
|
|---|---|---|
|
Radiographic Assessment: Aseptic Loosening
Immediate Post-Op to 6 weeks · Yes
|
0 Participants
|
0 Participants
|
|
Radiographic Assessment: Aseptic Loosening
Immediate Post-Op to 6 weeks · No
|
0 Participants
|
10 Participants
|
|
Radiographic Assessment: Aseptic Loosening
Immediate Post-Op to 6 weeks · Missing
|
43 Participants
|
6 Participants
|
|
Radiographic Assessment: Aseptic Loosening
6 months · Yes
|
0 Participants
|
0 Participants
|
|
Radiographic Assessment: Aseptic Loosening
6 months · No
|
1 Participants
|
6 Participants
|
|
Radiographic Assessment: Aseptic Loosening
6 months · Missing
|
36 Participants
|
3 Participants
|
|
Radiographic Assessment: Aseptic Loosening
1 year · Yes
|
0 Participants
|
0 Participants
|
|
Radiographic Assessment: Aseptic Loosening
1 year · No
|
0 Participants
|
3 Participants
|
|
Radiographic Assessment: Aseptic Loosening
1 year · Missing
|
27 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Immediate Post-op to 6 weeks, 6 months, 1 year, 2 yearsPopulation: Participants that received the study device with data collected for the outcome and time frame indicated. While general study duration covers 2 years, there were multiple sites with no participant reaching the 2 year visit for data collection due to study termination. Responses from a site indicated radiographic findings for participants in the un-resurfaced patella group (i.e., "Yes" to presence of radiographic findings), but 'No' indicated for the Septic Loosening radiographic finding option.
Standard radiographic evaluation on antero-posterior (A/P) and lateral views performed to identify the radiographic finding type by the presence of septic loosening as one of the following: * Yes * No * Missing
Outcome measures
| Measure |
Resurfaced/Non Patella
n=43 Participants
Undergoing Total Knee Replacement with JOURNEY II CR Total Knee System
Resurfaced Patella: JOURNEY II CR Total Knee System was used for Total Knee replacement
|
Un-resurfaced Patella
n=16 Participants
Undergoing Total Knee Replacement with JOURNEY II CR Total Knee System
Un-resurfaced Patella: JOURNEY II CR Total Knee System was used for Total Knee replacement
|
|---|---|---|
|
Radiographic Assessment: Septic Loosening
1 year · No
|
0 Participants
|
3 Participants
|
|
Radiographic Assessment: Septic Loosening
Immediate Post-Op to 6 weeks · Yes
|
0 Participants
|
0 Participants
|
|
Radiographic Assessment: Septic Loosening
Immediate Post-Op to 6 weeks · No
|
0 Participants
|
10 Participants
|
|
Radiographic Assessment: Septic Loosening
Immediate Post-Op to 6 weeks · Missing
|
43 Participants
|
6 Participants
|
|
Radiographic Assessment: Septic Loosening
6 months · Yes
|
0 Participants
|
0 Participants
|
|
Radiographic Assessment: Septic Loosening
6 months · No
|
1 Participants
|
6 Participants
|
|
Radiographic Assessment: Septic Loosening
6 months · Missing
|
36 Participants
|
3 Participants
|
|
Radiographic Assessment: Septic Loosening
1 year · Yes
|
0 Participants
|
0 Participants
|
|
Radiographic Assessment: Septic Loosening
1 year · Missing
|
27 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Immediate Post-op to 6 weeks, 6 months, 1 year, 2 yearsPopulation: Participants that received the study device with data collected for the outcome and time frame indicated. While general study duration covers 2 years, there were multiple sites with no participant reaching the 2 year visit for data collection due to study termination. Responses from one site indicated radiographic findings for participants in the un-resurfaced patella group (i.e., "Yes" to presence of radiographic findings), but 'No' indicated for the Bone Fracture radiographic finding option.
Standard radiographic evaluation on antero-posterior (A/P) and lateral views performed to identify the radiographic finding type by the presence of bone fracture as one of the following: * Yes * No * Missing
Outcome measures
| Measure |
Resurfaced/Non Patella
n=43 Participants
Undergoing Total Knee Replacement with JOURNEY II CR Total Knee System
Resurfaced Patella: JOURNEY II CR Total Knee System was used for Total Knee replacement
|
Un-resurfaced Patella
n=16 Participants
Undergoing Total Knee Replacement with JOURNEY II CR Total Knee System
Un-resurfaced Patella: JOURNEY II CR Total Knee System was used for Total Knee replacement
|
|---|---|---|
|
Radiographic Assessment: Bone Fracture
Immediate Post-Op to 6 weeks · Yes
|
0 Participants
|
0 Participants
|
|
Radiographic Assessment: Bone Fracture
Immediate Post-Op to 6 weeks · No
|
0 Participants
|
10 Participants
|
|
Radiographic Assessment: Bone Fracture
Immediate Post-Op to 6 weeks · Missing
|
43 Participants
|
6 Participants
|
|
Radiographic Assessment: Bone Fracture
6 months · Yes
|
0 Participants
|
0 Participants
|
|
Radiographic Assessment: Bone Fracture
6 months · No
|
1 Participants
|
6 Participants
|
|
Radiographic Assessment: Bone Fracture
6 months · Missing
|
36 Participants
|
3 Participants
|
|
Radiographic Assessment: Bone Fracture
1 year · Yes
|
0 Participants
|
0 Participants
|
|
Radiographic Assessment: Bone Fracture
1 year · No
|
0 Participants
|
3 Participants
|
|
Radiographic Assessment: Bone Fracture
1 year · Missing
|
27 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Immediate Post-op to 6 weeks, 6 months, 1 year, 2 yearsPopulation: Participants that received the study device with data collected for the outcome and time frame indicated. While general study duration covers 2 years, there were multiple sites with no participant reaching the 2 year visit for data collection due to study termination. Responses from one site indicated radiographic findings for participants in the un-resurfaced patella group (i.e., "Yes" to presence of radiographic findings), but 'No' indicated for the Cement Fracture radiographic finding option.
Standard radiographic evaluation on antero-posterior (A/P) and lateral views performed to identify the radiographic finding type by the presence of cement fracture as one of the following: * Yes * No * Missing
Outcome measures
| Measure |
Resurfaced/Non Patella
n=43 Participants
Undergoing Total Knee Replacement with JOURNEY II CR Total Knee System
Resurfaced Patella: JOURNEY II CR Total Knee System was used for Total Knee replacement
|
Un-resurfaced Patella
n=16 Participants
Undergoing Total Knee Replacement with JOURNEY II CR Total Knee System
Un-resurfaced Patella: JOURNEY II CR Total Knee System was used for Total Knee replacement
|
|---|---|---|
|
Radiographic Assessment: Cement Fracture
1 year · Missing
|
27 Participants
|
1 Participants
|
|
Radiographic Assessment: Cement Fracture
Immediate Post-Op to 6 weeks · Yes
|
0 Participants
|
0 Participants
|
|
Radiographic Assessment: Cement Fracture
Immediate Post-Op to 6 weeks · No
|
0 Participants
|
10 Participants
|
|
Radiographic Assessment: Cement Fracture
Immediate Post-Op to 6 weeks · Missing
|
43 Participants
|
6 Participants
|
|
Radiographic Assessment: Cement Fracture
6 months · Yes
|
0 Participants
|
0 Participants
|
|
Radiographic Assessment: Cement Fracture
6 months · No
|
1 Participants
|
6 Participants
|
|
Radiographic Assessment: Cement Fracture
6 months · Missing
|
36 Participants
|
3 Participants
|
|
Radiographic Assessment: Cement Fracture
1 year · Yes
|
0 Participants
|
0 Participants
|
|
Radiographic Assessment: Cement Fracture
1 year · No
|
0 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Immediate Post-op to 6 weeks, 6 months, 1 year, 2 yearsPopulation: Participants that received the study device with data collected for the outcome and time frame indicated. While general study duration covers 2 years, there were multiple sites with no participant reaching the 2 year visit for data collection due to study termination. Responses from one site indicated radiographic findings for participants in the un-resurfaced patella group (i.e., "Yes" to presence of radiographic findings), but 'No' indicated for the Osteolysis radiographic finding option.
Standard radiographic evaluation on antero-posterior (A/P) and lateral views performed to identify the radiographic finding type by the presence of osteolysis as one of the following: * Yes * No * Missing
Outcome measures
| Measure |
Resurfaced/Non Patella
n=43 Participants
Undergoing Total Knee Replacement with JOURNEY II CR Total Knee System
Resurfaced Patella: JOURNEY II CR Total Knee System was used for Total Knee replacement
|
Un-resurfaced Patella
n=16 Participants
Undergoing Total Knee Replacement with JOURNEY II CR Total Knee System
Un-resurfaced Patella: JOURNEY II CR Total Knee System was used for Total Knee replacement
|
|---|---|---|
|
Radiographic Assessment: Osteolysis
Immediate Post-Op to 6 weeks · Yes
|
0 Participants
|
0 Participants
|
|
Radiographic Assessment: Osteolysis
Immediate Post-Op to 6 weeks · No
|
0 Participants
|
10 Participants
|
|
Radiographic Assessment: Osteolysis
Immediate Post-Op to 6 weeks · Missing
|
43 Participants
|
6 Participants
|
|
Radiographic Assessment: Osteolysis
6 months · Yes
|
0 Participants
|
0 Participants
|
|
Radiographic Assessment: Osteolysis
6 months · No
|
1 Participants
|
6 Participants
|
|
Radiographic Assessment: Osteolysis
6 months · Missing
|
36 Participants
|
3 Participants
|
|
Radiographic Assessment: Osteolysis
1 year · Yes
|
0 Participants
|
0 Participants
|
|
Radiographic Assessment: Osteolysis
1 year · No
|
0 Participants
|
3 Participants
|
|
Radiographic Assessment: Osteolysis
1 year · Missing
|
27 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Immediate Post-op to 6 weeks, 6 months, 1 year, 2 yearsPopulation: Participants that received the study device with data collected for the outcome and time frame indicated. While general study duration covers 2 years, there were multiple sites with no participant reaching the 2 year visit for data collection due to study termination. Responses from one site indicated radiographic findings for participants in the un-resurfaced patella group (i.e., "Yes" to presence of radiographic findings), but 'No' indicated for the Subsidence radiographic finding option.
Standard radiographic evaluation on antero-posterior (A/P) and lateral views performed to identify the radiographic finding type by the presence of subsidence as one of the following: * Yes * No * Missing
Outcome measures
| Measure |
Resurfaced/Non Patella
n=43 Participants
Undergoing Total Knee Replacement with JOURNEY II CR Total Knee System
Resurfaced Patella: JOURNEY II CR Total Knee System was used for Total Knee replacement
|
Un-resurfaced Patella
n=16 Participants
Undergoing Total Knee Replacement with JOURNEY II CR Total Knee System
Un-resurfaced Patella: JOURNEY II CR Total Knee System was used for Total Knee replacement
|
|---|---|---|
|
Radiographic Assessment: Subsidence
Immediate Post-Op to 6 weeks · No
|
0 Participants
|
10 Participants
|
|
Radiographic Assessment: Subsidence
6 months · Missing
|
36 Participants
|
3 Participants
|
|
Radiographic Assessment: Subsidence
Immediate Post-Op to 6 weeks · Yes
|
0 Participants
|
0 Participants
|
|
Radiographic Assessment: Subsidence
Immediate Post-Op to 6 weeks · Missing
|
43 Participants
|
6 Participants
|
|
Radiographic Assessment: Subsidence
6 months · Yes
|
0 Participants
|
0 Participants
|
|
Radiographic Assessment: Subsidence
6 months · No
|
1 Participants
|
6 Participants
|
|
Radiographic Assessment: Subsidence
1 year · Yes
|
0 Participants
|
0 Participants
|
|
Radiographic Assessment: Subsidence
1 year · No
|
0 Participants
|
3 Participants
|
|
Radiographic Assessment: Subsidence
1 year · Missing
|
27 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Immediate Post-op to 6 weeks, 6 months, 1 year, 2 yearsPopulation: Participants that received the study device with data collected for the outcome and time frame indicated. While general study duration covers 2 years, there were multiple sites with no participant reaching the 2 year visit for data collection due to study termination. Responses from a site indicated radiographic findings for participants in the un-resurfaced patella group (i.e., "Yes" to presence of radiographic findings), but 'No' indicated for the Implant Migration radiographic finding option.
Standard radiographic evaluation on antero-posterior (A/P) and lateral views performed to identify the radiographic finding type by the presence of implant migration as one of the following: * Yes * No * Missing
Outcome measures
| Measure |
Resurfaced/Non Patella
n=43 Participants
Undergoing Total Knee Replacement with JOURNEY II CR Total Knee System
Resurfaced Patella: JOURNEY II CR Total Knee System was used for Total Knee replacement
|
Un-resurfaced Patella
n=16 Participants
Undergoing Total Knee Replacement with JOURNEY II CR Total Knee System
Un-resurfaced Patella: JOURNEY II CR Total Knee System was used for Total Knee replacement
|
|---|---|---|
|
Radiographic Assessment: Implant Migration
1 year · Missing
|
27 Participants
|
1 Participants
|
|
Radiographic Assessment: Implant Migration
Immediate Post-Op to 6 weeks · Yes
|
0 Participants
|
0 Participants
|
|
Radiographic Assessment: Implant Migration
Immediate Post-Op to 6 weeks · No
|
0 Participants
|
10 Participants
|
|
Radiographic Assessment: Implant Migration
Immediate Post-Op to 6 weeks · Missing
|
43 Participants
|
6 Participants
|
|
Radiographic Assessment: Implant Migration
6 months · Yes
|
0 Participants
|
0 Participants
|
|
Radiographic Assessment: Implant Migration
6 months · No
|
1 Participants
|
6 Participants
|
|
Radiographic Assessment: Implant Migration
6 months · Missing
|
36 Participants
|
3 Participants
|
|
Radiographic Assessment: Implant Migration
1 year · Yes
|
0 Participants
|
0 Participants
|
|
Radiographic Assessment: Implant Migration
1 year · No
|
0 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Immediate Post-op to 6 weeks, 6 months, 1 year, 2 yearsPopulation: Participants that received the study device with data collected for the outcome and time frame indicated. While general study duration covers 2 years, there were multiple sites with no participant reaching the 2 year visit for data collection due to study termination. Responses from a site indicated radiographic findings for participants in the un-resurfaced patella group (i.e., "Yes" to presence of radiographic findings), but 'No' indicated for the Stress Shielding radiographic finding option.
Standard radiographic evaluation on antero-posterior (A/P) and lateral views performed to identify the radiographic finding type by the presence of stress shielding as one of the following: * Yes * No * Missing
Outcome measures
| Measure |
Resurfaced/Non Patella
n=43 Participants
Undergoing Total Knee Replacement with JOURNEY II CR Total Knee System
Resurfaced Patella: JOURNEY II CR Total Knee System was used for Total Knee replacement
|
Un-resurfaced Patella
n=16 Participants
Undergoing Total Knee Replacement with JOURNEY II CR Total Knee System
Un-resurfaced Patella: JOURNEY II CR Total Knee System was used for Total Knee replacement
|
|---|---|---|
|
Radiographic Assessment: Stress Shielding
Immediate Post-Op to 6 weeks · Yes
|
0 Participants
|
0 Participants
|
|
Radiographic Assessment: Stress Shielding
Immediate Post-Op to 6 weeks · No
|
0 Participants
|
10 Participants
|
|
Radiographic Assessment: Stress Shielding
Immediate Post-Op to 6 weeks · Missing
|
43 Participants
|
6 Participants
|
|
Radiographic Assessment: Stress Shielding
6 months · Yes
|
1 Participants
|
0 Participants
|
|
Radiographic Assessment: Stress Shielding
6 months · No
|
0 Participants
|
6 Participants
|
|
Radiographic Assessment: Stress Shielding
6 months · Missing
|
36 Participants
|
3 Participants
|
|
Radiographic Assessment: Stress Shielding
1 year · Yes
|
0 Participants
|
0 Participants
|
|
Radiographic Assessment: Stress Shielding
1 year · No
|
0 Participants
|
3 Participants
|
|
Radiographic Assessment: Stress Shielding
1 year · Missing
|
27 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Immediate Post-op to 6 weeks, 6 months, 1 year, 2 yearsPopulation: Participants that received the study device with data collected for the outcome and time frame indicated. While general study duration covers 2 years, there were multiple sites with no participant reaching the 2 year visit for data collection due to study termination. Responses from a site indicated findings for participants in the un-resurfaced patella group (i.e., "Yes" to presence of radiographic findings), but 'No' indicated for the Implant-Cement Debonding radiographic finding option.
Standard radiographic evaluation on antero-posterior (A/P) and lateral views performed to identify the radiographic finding type by the presence of implant-cement debonding as one of the following: * Yes * No * Missing
Outcome measures
| Measure |
Resurfaced/Non Patella
n=43 Participants
Undergoing Total Knee Replacement with JOURNEY II CR Total Knee System
Resurfaced Patella: JOURNEY II CR Total Knee System was used for Total Knee replacement
|
Un-resurfaced Patella
n=16 Participants
Undergoing Total Knee Replacement with JOURNEY II CR Total Knee System
Un-resurfaced Patella: JOURNEY II CR Total Knee System was used for Total Knee replacement
|
|---|---|---|
|
Radiographic Assessment: Implant-Cement Debonding
Immediate Post-Op to 6 weeks · Yes
|
0 Participants
|
0 Participants
|
|
Radiographic Assessment: Implant-Cement Debonding
Immediate Post-Op to 6 weeks · No
|
0 Participants
|
10 Participants
|
|
Radiographic Assessment: Implant-Cement Debonding
6 months · No
|
1 Participants
|
6 Participants
|
|
Radiographic Assessment: Implant-Cement Debonding
Immediate Post-Op to 6 weeks · Missing
|
43 Participants
|
6 Participants
|
|
Radiographic Assessment: Implant-Cement Debonding
6 months · Yes
|
0 Participants
|
0 Participants
|
|
Radiographic Assessment: Implant-Cement Debonding
6 months · Missing
|
36 Participants
|
3 Participants
|
|
Radiographic Assessment: Implant-Cement Debonding
1 year · Yes
|
0 Participants
|
0 Participants
|
|
Radiographic Assessment: Implant-Cement Debonding
1 year · No
|
0 Participants
|
3 Participants
|
|
Radiographic Assessment: Implant-Cement Debonding
1 year · Missing
|
27 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Pre-Operative, 6 months, 1 year, 2 yearsPopulation: While general study duration does cover 2 years, there were multiple sites. No participant at any site reached the 2 year time point because the study was terminated before any of the data was collected for any visit on or after the 2 year visit. Additionally, 0 participants were analyzed at 1 year for mechanical axis alignment because data was not provided by the third party central imaging lab due to contract suspension and later study termination, so data after 6 months cannot be reported.
Standard radiographic evaluation on antero-posterior (A/P) and lateral views performed to determine mechanical axis alignment of the knee joint in degrees measured through the centre of the hip (centre of the spherical femoral head), centre of the knee (centre of the tibial plateau) and centre of the ankle (centre of the talus).
Outcome measures
| Measure |
Resurfaced/Non Patella
n=44 Participants
Undergoing Total Knee Replacement with JOURNEY II CR Total Knee System
Resurfaced Patella: JOURNEY II CR Total Knee System was used for Total Knee replacement
|
Un-resurfaced Patella
n=16 Participants
Undergoing Total Knee Replacement with JOURNEY II CR Total Knee System
Un-resurfaced Patella: JOURNEY II CR Total Knee System was used for Total Knee replacement
|
|---|---|---|
|
Radiographic Assessment: Mechanical Axis Alignment of the Knee Joint
Pre-Operative
|
7.1 degrees
Standard Deviation 5.1
|
9.6 degrees
Standard Deviation 6.4
|
|
Radiographic Assessment: Mechanical Axis Alignment of the Knee Joint
6 months
|
1.5 degrees
Standard Deviation 1.7
|
1.5 degrees
Standard Deviation 1.4
|
Adverse Events
Resurfaced/Non Patella
Un-resurfaced Patella
Serious adverse events
| Measure |
Resurfaced/Non Patella
n=44 participants at risk
Undergoing Total Knee Replacement with JOURNEY II CR Total Knee System
Resurfaced Patella: JOURNEY II CR Total Knee System was used for Total Knee replacement
|
Un-resurfaced Patella
n=16 participants at risk
Undergoing Total Knee Replacement with JOURNEY II CR Total Knee System
Un-resurfaced Patella: JOURNEY II CR Total Knee System was used for Total Knee replacement
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
OSTEOARTHRITIS IN THE CARPOMETACARPAL JOINT OF THE RIGHT THUMB
|
2.3%
1/44 • Adverse events were collected from surgery to study termination, approximately 1 year.
|
0.00%
0/16 • Adverse events were collected from surgery to study termination, approximately 1 year.
|
|
Hepatobiliary disorders
ACUTE GALLBLADDER INFLAMMATION
|
2.3%
1/44 • Adverse events were collected from surgery to study termination, approximately 1 year.
|
0.00%
0/16 • Adverse events were collected from surgery to study termination, approximately 1 year.
|
|
Reproductive system and breast disorders
LOCALIZED PROSTATE CANCER
|
2.3%
1/44 • Adverse events were collected from surgery to study termination, approximately 1 year.
|
0.00%
0/16 • Adverse events were collected from surgery to study termination, approximately 1 year.
|
|
Musculoskeletal and connective tissue disorders
STERNUM FRACTURE
|
2.3%
1/44 • Adverse events were collected from surgery to study termination, approximately 1 year.
|
0.00%
0/16 • Adverse events were collected from surgery to study termination, approximately 1 year.
|
|
Reproductive system and breast disorders
LEFT BREAST CANCER
|
2.3%
1/44 • Adverse events were collected from surgery to study termination, approximately 1 year.
|
0.00%
0/16 • Adverse events were collected from surgery to study termination, approximately 1 year.
|
|
Musculoskeletal and connective tissue disorders
LEFT KNEE OSTEOARTHRITIS
|
2.3%
1/44 • Adverse events were collected from surgery to study termination, approximately 1 year.
|
0.00%
0/16 • Adverse events were collected from surgery to study termination, approximately 1 year.
|
|
Musculoskeletal and connective tissue disorders
PAIN AND SWELLING DYSFUNCTION AFTER RIGHT KNEE REPLACEMENT
|
0.00%
0/44 • Adverse events were collected from surgery to study termination, approximately 1 year.
|
6.2%
1/16 • Adverse events were collected from surgery to study termination, approximately 1 year.
|
|
Musculoskeletal and connective tissue disorders
PAIN AFTER RIGHT KNEE REPLACEMENT
|
0.00%
0/44 • Adverse events were collected from surgery to study termination, approximately 1 year.
|
6.2%
1/16 • Adverse events were collected from surgery to study termination, approximately 1 year.
|
Other adverse events
| Measure |
Resurfaced/Non Patella
n=44 participants at risk
Undergoing Total Knee Replacement with JOURNEY II CR Total Knee System
Resurfaced Patella: JOURNEY II CR Total Knee System was used for Total Knee replacement
|
Un-resurfaced Patella
n=16 participants at risk
Undergoing Total Knee Replacement with JOURNEY II CR Total Knee System
Un-resurfaced Patella: JOURNEY II CR Total Knee System was used for Total Knee replacement
|
|---|---|---|
|
General disorders
FEVER
|
6.8%
3/44 • Adverse events were collected from surgery to study termination, approximately 1 year.
|
0.00%
0/16 • Adverse events were collected from surgery to study termination, approximately 1 year.
|
|
Reproductive system and breast disorders
UTERINE MYOMA
|
2.3%
1/44 • Adverse events were collected from surgery to study termination, approximately 1 year.
|
0.00%
0/16 • Adverse events were collected from surgery to study termination, approximately 1 year.
|
|
Musculoskeletal and connective tissue disorders
ILIOTIBIAL BAND SYNDROME OF RIGHT LEG
|
2.3%
1/44 • Adverse events were collected from surgery to study termination, approximately 1 year.
|
0.00%
0/16 • Adverse events were collected from surgery to study termination, approximately 1 year.
|
|
Musculoskeletal and connective tissue disorders
NUMBNESS IN RIGHT TOES
|
2.3%
1/44 • Adverse events were collected from surgery to study termination, approximately 1 year.
|
0.00%
0/16 • Adverse events were collected from surgery to study termination, approximately 1 year.
|
|
Ear and labyrinth disorders
RIGHT OTITIS MEDIA WITH EFFUSION
|
2.3%
1/44 • Adverse events were collected from surgery to study termination, approximately 1 year.
|
0.00%
0/16 • Adverse events were collected from surgery to study termination, approximately 1 year.
|
|
Infections and infestations
ORAL CANDIDIASIS
|
2.3%
1/44 • Adverse events were collected from surgery to study termination, approximately 1 year.
|
0.00%
0/16 • Adverse events were collected from surgery to study termination, approximately 1 year.
|
|
General disorders
DIZZINESS
|
0.00%
0/44 • Adverse events were collected from surgery to study termination, approximately 1 year.
|
6.2%
1/16 • Adverse events were collected from surgery to study termination, approximately 1 year.
|
|
Musculoskeletal and connective tissue disorders
LEFT COXODYNIA
|
2.3%
1/44 • Adverse events were collected from surgery to study termination, approximately 1 year.
|
0.00%
0/16 • Adverse events were collected from surgery to study termination, approximately 1 year.
|
|
Musculoskeletal and connective tissue disorders
PRIMARY HAND ARTHROPATHY OF RIGHT HAND
|
2.3%
1/44 • Adverse events were collected from surgery to study termination, approximately 1 year.
|
0.00%
0/16 • Adverse events were collected from surgery to study termination, approximately 1 year.
|
|
Nervous system disorders
PERIPHERAL NEUROPATHY
|
2.3%
1/44 • Adverse events were collected from surgery to study termination, approximately 1 year.
|
0.00%
0/16 • Adverse events were collected from surgery to study termination, approximately 1 year.
|
|
Ear and labyrinth disorders
MENIERE'S DISEASE
|
2.3%
1/44 • Adverse events were collected from surgery to study termination, approximately 1 year.
|
0.00%
0/16 • Adverse events were collected from surgery to study termination, approximately 1 year.
|
|
General disorders
LEFT LUMBALGIA
|
2.3%
1/44 • Adverse events were collected from surgery to study termination, approximately 1 year.
|
0.00%
0/16 • Adverse events were collected from surgery to study termination, approximately 1 year.
|
|
General disorders
TRANSIENT LOSS OF CONSCIOUSNESS
|
2.3%
1/44 • Adverse events were collected from surgery to study termination, approximately 1 year.
|
0.00%
0/16 • Adverse events were collected from surgery to study termination, approximately 1 year.
|
|
Skin and subcutaneous tissue disorders
SEBORRHEIC DERMATITIS
|
2.3%
1/44 • Adverse events were collected from surgery to study termination, approximately 1 year.
|
0.00%
0/16 • Adverse events were collected from surgery to study termination, approximately 1 year.
|
|
Musculoskeletal and connective tissue disorders
LUMBAR SPINAL STENOSIS
|
2.3%
1/44 • Adverse events were collected from surgery to study termination, approximately 1 year.
|
0.00%
0/16 • Adverse events were collected from surgery to study termination, approximately 1 year.
|
|
Skin and subcutaneous tissue disorders
UPPER AND LOWER EXTREMITY ERUPTION
|
2.3%
1/44 • Adverse events were collected from surgery to study termination, approximately 1 year.
|
0.00%
0/16 • Adverse events were collected from surgery to study termination, approximately 1 year.
|
|
Gastrointestinal disorders
CONSTIPATION
|
2.3%
1/44 • Adverse events were collected from surgery to study termination, approximately 1 year.
|
0.00%
0/16 • Adverse events were collected from surgery to study termination, approximately 1 year.
|
|
Renal and urinary disorders
CYSTITIS
|
2.3%
1/44 • Adverse events were collected from surgery to study termination, approximately 1 year.
|
0.00%
0/16 • Adverse events were collected from surgery to study termination, approximately 1 year.
|
|
Musculoskeletal and connective tissue disorders
RIGHT ANKLE SPRAIN
|
2.3%
1/44 • Adverse events were collected from surgery to study termination, approximately 1 year.
|
0.00%
0/16 • Adverse events were collected from surgery to study termination, approximately 1 year.
|
|
Gastrointestinal disorders
REFLUX ESOPHAGITIS
|
2.3%
1/44 • Adverse events were collected from surgery to study termination, approximately 1 year.
|
0.00%
0/16 • Adverse events were collected from surgery to study termination, approximately 1 year.
|
|
Skin and subcutaneous tissue disorders
ECZEMA
|
2.3%
1/44 • Adverse events were collected from surgery to study termination, approximately 1 year.
|
0.00%
0/16 • Adverse events were collected from surgery to study termination, approximately 1 year.
|
|
Renal and urinary disorders
URINARY TRACT INFECTION
|
4.5%
2/44 • Adverse events were collected from surgery to study termination, approximately 1 year.
|
0.00%
0/16 • Adverse events were collected from surgery to study termination, approximately 1 year.
|
|
Skin and subcutaneous tissue disorders
BOTH LOWER EXTREMITY ERUPTION
|
2.3%
1/44 • Adverse events were collected from surgery to study termination, approximately 1 year.
|
0.00%
0/16 • Adverse events were collected from surgery to study termination, approximately 1 year.
|
|
Ear and labyrinth disorders
TINNITUS
|
2.3%
1/44 • Adverse events were collected from surgery to study termination, approximately 1 year.
|
0.00%
0/16 • Adverse events were collected from surgery to study termination, approximately 1 year.
|
|
Musculoskeletal and connective tissue disorders
LEFT LOWER LEG CRAMPS IN THE CALVES
|
2.3%
1/44 • Adverse events were collected from surgery to study termination, approximately 1 year.
|
0.00%
0/16 • Adverse events were collected from surgery to study termination, approximately 1 year.
|
|
Musculoskeletal and connective tissue disorders
LUMBAR PAIN
|
2.3%
1/44 • Adverse events were collected from surgery to study termination, approximately 1 year.
|
0.00%
0/16 • Adverse events were collected from surgery to study termination, approximately 1 year.
|
|
Psychiatric disorders
MALAISE
|
2.3%
1/44 • Adverse events were collected from surgery to study termination, approximately 1 year.
|
0.00%
0/16 • Adverse events were collected from surgery to study termination, approximately 1 year.
|
|
Musculoskeletal and connective tissue disorders
SCIATICA
|
4.5%
2/44 • Adverse events were collected from surgery to study termination, approximately 1 year.
|
0.00%
0/16 • Adverse events were collected from surgery to study termination, approximately 1 year.
|
|
Gastrointestinal disorders
GASTRALGIA
|
2.3%
1/44 • Adverse events were collected from surgery to study termination, approximately 1 year.
|
0.00%
0/16 • Adverse events were collected from surgery to study termination, approximately 1 year.
|
|
Nervous system disorders
TREMORS
|
0.00%
0/44 • Adverse events were collected from surgery to study termination, approximately 1 year.
|
6.2%
1/16 • Adverse events were collected from surgery to study termination, approximately 1 year.
|
Additional Information
Senior Manager Clinical Compliance
Smith+Nephew, Inc
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place