Evaluate the Performance of JOURNEY II CR and JOURNEY II BCS in TKA Populations

The FJS comprises measures for the assessment of joint-specific patient reported outcomes. This questionnaire focuses on the study subject'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. Subjects 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.

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. 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.

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:

1. An "Objective" Knee Score (seven items: 100 points)
2. A Patient Satisfaction Score (five items: 40 points)
3. A Patient Expectation Score (three items: 15 points)
4. A Functional Knee Score (19 items: 100 points)

The Functional Knee Score is derived from assessments of walking and standing, standard activities, advanced activities, and discretionary activities. A higher number is a better outcome.

The patient expectation will be one single question which have 9 options to choose.

Patients need to choose at which level of activity he/she expect to recover after surgery.

The option will be from the most intensive activity to least intensive activity.

The patient satisfaction will be a corresponding question based on the expectation. It's a five -Likert options (from very satisfied to very dissatisfied) for patients to choose how satisfied he/she is with the surgery to meet the expectation.

Standard radiographic evaluation on antero-posterior (A/P) and lateral views shall be performed at the determined time point before and after surgery in order to identify any radiographic observations such as radiolucent lines around the implant components. The presence of radiolucent lines, osteolysis \& implant migration shall be recorded in the electronic Case Report Form (eCRF).

The Timed Up and Go Test assesses mobility, balance, walking ability, and fall risk in adults by measuring time, in seconds, that it takes the individual to stand from a chair, walk a distance of 10 feet (around 3 meters), walk back to the chair, and sit down. The subject will perform the test in their everyday footwear with their walking aid (cane, walker), if applicable [39]. The site will follow the guidelines provided by the Centers for Disease Control and Prevention recording the results on the form provided by the Sponsor

The SEBT has been introduced as a simple, reliable, and cost-effective alternative for instrumental devices to assess semi-dynamic balance. The SEBT is a functional test that incorporates a single-leg stance on 1 leg while trying to reach as far as possible with the opposite leg. Each patient performed 3 reaches (trials) in each of the 8 directions. The average of the maximum reach distance in each of the 8 directions was considered for analysis.