Evaluate the Performance of JOURNEY II CR in TKA Populations

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.

Time frame: 2 years

Population: 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 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).

Time frame: 6 months, 1 year, 2 years, 3 years

Population: 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.

Time frame: Pre-Operative, 6 months, 1 year, 2 years, 3 years

Population: 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.

Time frame: Pre-Operative, 6 months, 1 year, 2 years, 3 years

Population: 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.

Time frame: Pre-Operative, 6 months, 1 year, 2 years, 3 years

Population: 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.

Time frame: Pre-Operative, 6 months, 1 year, 2 years, 3 years

Population: 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.

Time frame: Pre-Operative, 6 months, 1 year, 3 years

Population: 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 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

Time frame: Pre-Operative

Population: Participants that received the study device with data collected for the outcome and time frame indicated.

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

Time frame: 6 months, 1 year, 2 years, 3 years

Population: 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 radiographic finding type by the presence of aseptic loosening as one of the following: * Yes * No * Missing

Time frame: Immediate Post-op to 6 weeks, 6 months, 1 year, 2 years

Population: 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 bone fracture as one of the following: * Yes * No * Missing

Time frame: Immediate Post-op to 6 weeks, 6 months, 1 year, 2 years

Population: 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 cement fracture as one of the following: * Yes * No * Missing

Time frame: Immediate Post-op to 6 weeks, 6 months, 1 year, 2 years

Population: 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 implant-cement debonding as one of the following: * Yes * No * Missing

Time frame: Immediate Post-op to 6 weeks, 6 months, 1 year, 2 years

Population: 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 migration as one of the following: * Yes * No * Missing

Time frame: Immediate Post-op to 6 weeks, 6 months, 1 year, 2 years

Population: 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 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).

Time frame: Pre-Operative, 6 months, 1 year, 2 years

Population: 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 identify the radiographic finding type by the presence of osteolysis as one of the following: * Yes * No * Missing

Time frame: Immediate Post-op to 6 weeks, 6 months, 1 year, 2 years

Population: 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 number of participants with the presence of radiographic findings categorized as: * Yes * No * Missing

Time frame: Immediate Post-op to 6 weeks, 6 months, 1 year, 2 years

Population: 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 radiographic finding type by the presence of septic loosening as one of the following: * Yes * No * Missing

Time frame: Immediate Post-op to 6 weeks, 6 months, 1 year, 2 years

Population: 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 stress shielding as one of the following: * Yes * No * Missing

Time frame: Immediate Post-op to 6 weeks, 6 months, 1 year, 2 years

Population: 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 subsidence as one of the following: * Yes * No * Missing

Time frame: Immediate Post-op to 6 weeks, 6 months, 1 year, 2 years

Population: 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.