Evaluate the Performance of JOURNEY II CR in TKA Populations

Study Overview
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Brief Summary
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Background: The JOURNEY II CR Total Knee System consists of femoral component made from oxidized zirconium (OXINIUM) Purpose: Post-market evidence generation for JOURNEY II CR Total Knee System Objectives: Evaluate the performance of JOURNEY II CR TKA in APAC populations Evaluate the impact of patella resurfacing on the outcomes of JOURNEY II CR TKA Research participants / locations: A total of up to 480 knees' information will be collected in up to 15 sites in India, China mainland, Hong Kong, Singapore, Thailand and Japan There will be up to 240 knees for resurfaced patella group and up to 240 knees for un-resurfaced patella group.

Official Title
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A Prospective Multi-Centre Study in Patients Undergoing Total Knee Replacement With JOURNEY II CR Total Knee System

Conditions
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Arthroplasty, Replacement, Knee

Intervention / Treatment
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* Device: Resurfaced Patella
* Procedure: Un-resurfaced Patella


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects with degenerative osteoarthritis. Subject is planning to have TKA using JOURNEY II CR. Subject is able and willing to provide voluntary consent to study participation. Subject is 18-80 years old (inclusive) * (* For Japan, the minimum inclusion age is 20 years old.) Exclusion Criteria: Subjects with rheumatoid arthritis/inflammatory arthritis, posttraumatic arthritis. Previous surgeries including HTO, UKA or TKA on the subject knee. Subject is pregnant or breast feeding or those at a child-bearing age planning to become pregnant during the follow up. Subject does not meet the indication or is contraindicated for JOURNEY II CR's IFU.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Resurfaced/non patella<br>Undergoing Total Knee Replacement with JOURNEY II CR Total Knee System | Device: Resurfaced Patella<br>* JOURNEY II CR Total Knee System was used for Total Knee replacement<br>|
| un-resurfaced patella<br>Undergoing Total Knee Replacement with JOURNEY II CR Total Knee System | Procedure: Un-resurfaced Patella<br>* JOURNEY II CR Total Knee System was used for Total Knee replacement<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oxford Knee Score (OKS) at 2 years | 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. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Forgotten Joint Score (FJS) | 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. | 6 months, 1 year , 2 years , 3 years | 
| Oxford Knee Score (OKS) | 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. | Pre-Operative, 6 months, 1 year, 3 years | 
| Knee Society Score (KSS) | 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: An Objective Knee Score (seven items: 100 points) A Patient Satisfaction Score (five items: 40 points) A Patient Expectation Score (three items: 15 points) 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. | Pre-Operative, 6 months, 1 year, 2 years, 3 years | 
| Patient Expectation | Patient expectation is 1 question with 9 choices ranging from most to least intensive activity asking which level of activity they expect to recover. 1 activity is selected from 9 options: Regularly participate in impact sports such as jogging,tennis,skiing,acrobatics,ballet,heavy labor,backpacking,basketball,mountain climbing or badminton(with running & jumping) Sometime participate in impact sports Regularly participate in very active events, such as bowling, golf, table tennis, badminton (without running & jumping) or fitness walking Regularly participate in active events, such as bicycling or square dancing Regularly participate in moderate activities, such as swimming & unlimited housework, shopping or Tai Chi Sometimes participate in moderate activities Regularly participate in mild activities, such as walking, limited housework, & limited shopping Sometimes participate in mild activities Restricted to minimal activities of daily living | Pre-Operative | 
| Patient Satisfaction | 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. | 6 months, 1 year, 2 years, 3 years | 
| Radiographic Assessment | 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 eCRF. | Pre-Operative, Immediate Post-op to 6 weeks, 6 months, 1 year, 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Osteoarthritis, Total knee arthroplasty (TKA)