Evaluate the Performance of JOURNEY II CR in TKA Populations (JIICRTKA)

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

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.

Study Overview

• Status: Terminated
• Conditions: Arthroplasty; Knee; Replacement
• Intervention / Treatment: Device: Resurfaced Patella; Procedure: Un-resurfaced Patella

• Study Type: Observational
• Enrollment (Actual): 62

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100083
    • Peking University Third Hospital
  • Hong Kong, China
    • Prince of Wales Hospital
• India
  • Karnataka
    • Bengaluru, Karnataka, India, 560078
      • Aster RV Hospital, Bangalore
  • Maharashtra
    • Pune, Maharashtra, India, 411040
      • Arcus Hospital
• Japan
  • Tokyo, Japan, 1628666
    • Tokyo Women's Medical University
  • Tokyo, Japan, 1438540
    • Toho University Omori Medical Center
• Singapore
  • Singapore, Singapore, 169608
    • Singapore General Hospital
• Thailand
  • Bangkok, Thailand, 10330
    • Chulalongkorn Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Resurfaced/non patella; Undergoing Total Knee Replacement with JOURNEY II CR Total Knee System	Device: 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	Procedure: Un-resurfaced Patella; JOURNEY II CR Total Knee System was used for Total Knee replacement

What is the study measuring?

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 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).	6 months, 1 year, 2 years, 3 years
Oxford Knee Score (OKS)	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.	Pre-Operative, 6 months, 1 year, 3 years
Knee Society Score (KSS): "Objective" Knee Score	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.	Pre-Operative, 6 months, 1 year, 2 years, 3 years
Knee Society Score (KSS): Patient Satisfaction Score	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.	Pre-Operative, 6 months, 1 year, 2 years, 3 years
Knee Society Score (KSS): Patient Expectation Score	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.	Pre-Operative, 6 months, 1 year, 2 years, 3 years
Knee Society Score (KSS): Functional Knee Score	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.	Pre-Operative, 6 months, 1 year, 2 years, 3 years
Patient Expectation	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: Regularly participate in impact sports (e.g., 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 (e.g., bowling, golf, table tennis, badminton without running & jumping or fitness walking); Regularly participate in active events (e.g., bicycling or square dancing); Regularly participate in moderate activities (e.g., swimming & unlimited housework, shopping or Tai Chi); Sometimes participate in moderate activities; Regularly participate in mild activities (e.g., walking, limited housework, & limited shopping); Sometimes participate in mild activities; Restricted to minimal activities of daily living; Missing	Pre-Operative
Patient Satisfaction	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	6 months, 1 year, 2 years, 3 years
Radiographic Assessment: Presence of Radiographic Findings	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	Immediate Post-op to 6 weeks, 6 months, 1 year, 2 years
Radiographic Assessment: Aseptic Loosening	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	Immediate Post-op to 6 weeks, 6 months, 1 year, 2 years
Radiographic Assessment: Septic Loosening	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	Immediate Post-op to 6 weeks, 6 months, 1 year, 2 years
Radiographic Assessment: Bone Fracture	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	Immediate Post-op to 6 weeks, 6 months, 1 year, 2 years
Radiographic Assessment: Cement Fracture	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	Immediate Post-op to 6 weeks, 6 months, 1 year, 2 years
Radiographic Assessment: Osteolysis	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	Immediate Post-op to 6 weeks, 6 months, 1 year, 2 years
Radiographic Assessment: Subsidence	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	Immediate Post-op to 6 weeks, 6 months, 1 year, 2 years
Radiographic Assessment: Implant Migration	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	Immediate Post-op to 6 weeks, 6 months, 1 year, 2 years
Radiographic Assessment: Stress Shielding	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	Immediate Post-op to 6 weeks, 6 months, 1 year, 2 years
Radiographic Assessment: Implant-Cement Debonding	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	Immediate Post-op to 6 weeks, 6 months, 1 year, 2 years
Radiographic Assessment: Mechanical Axis Alignment of the Knee Joint	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).	Pre-Operative, 6 months, 1 year, 2 years

Collaborators and Investigators

• Sponsor: Smith & Nephew, Inc.
• Investigators: Study Director: Julian Yang, Smith & Nephew, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): March 3, 2022
• Primary Completion (Actual): March 15, 2024
• Study Completion (Actual): March 15, 2024

Study Registration Dates

• First Submitted: March 24, 2021
• First Submitted That Met QC Criteria: March 24, 2021
• First Posted (Actual): March 26, 2021

Study Record Updates

• Last Update Posted (Actual): August 20, 2025
• Last Update Submitted That Met QC Criteria: August 1, 2025
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Osteoarthritis; Total knee arthroplasty (TKA)
• Other Study ID Numbers: Journey II CR.2020.11

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO