Evaluate the Performance of JOURNEY II CR in TKA Populations

Terminated

Conditions: Knee
Arthroplasty
Replacement

Registration Number: NCT04818840

Lead Sponsor: Smith & Nephew, Inc.

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 62

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 & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Oxford Knee Score (OKS) at 2 Years	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.

Secondary Outcome Measures

Name	Time	Method
Forgotten Joint Score (FJS)	6 months, 1 year, 2 years, 3 years	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).
Oxford Knee Score (OKS)	Pre-Operative, 6 months, 1 year, 3 years	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.
Knee Society Score (KSS): "Objective" Knee Score	Pre-Operative, 6 months, 1 year, 2 years, 3 years	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.
Knee Society Score (KSS): Patient Satisfaction Score	Pre-Operative, 6 months, 1 year, 2 years, 3 years	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.
Knee Society Score (KSS): Patient Expectation Score	Pre-Operative, 6 months, 1 year, 2 years, 3 years	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.
Knee Society Score (KSS): Functional Knee Score	Pre-Operative, 6 months, 1 year, 2 years, 3 years	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.
Patient Expectation	Pre-Operative	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
Patient Satisfaction	6 months, 1 year, 2 years, 3 years	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
Radiographic Assessment: Presence of Radiographic Findings	Immediate Post-op to 6 weeks, 6 months, 1 year, 2 years	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
Radiographic Assessment: Aseptic Loosening	Immediate Post-op to 6 weeks, 6 months, 1 year, 2 years	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
Radiographic Assessment: Septic Loosening	Immediate Post-op to 6 weeks, 6 months, 1 year, 2 years	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
Radiographic Assessment: Bone Fracture	Immediate Post-op to 6 weeks, 6 months, 1 year, 2 years	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
Radiographic Assessment: Implant-Cement Debonding	Immediate Post-op to 6 weeks, 6 months, 1 year, 2 years	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
Radiographic Assessment: Cement Fracture	Immediate Post-op to 6 weeks, 6 months, 1 year, 2 years	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
Radiographic Assessment: Osteolysis	Immediate Post-op to 6 weeks, 6 months, 1 year, 2 years	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
Radiographic Assessment: Subsidence	Immediate Post-op to 6 weeks, 6 months, 1 year, 2 years	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
Radiographic Assessment: Implant Migration	Immediate Post-op to 6 weeks, 6 months, 1 year, 2 years	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
Radiographic Assessment: Stress Shielding	Immediate Post-op to 6 weeks, 6 months, 1 year, 2 years	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
Radiographic Assessment: Mechanical Axis Alignment of the Knee Joint	Pre-Operative, 6 months, 1 year, 2 years	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).

Trial Locations

Locations (8): Peking University Third Hospital
🇨🇳
Beijing, China
Prince of Wales Hospital
🇨🇳
Hong Kong, China
Aster RV Hospital, Bangalore
🇮🇳
Bengaluru, Karnataka, India
Arcus Hospital
🇮🇳
Pune, Maharashtra, India
Toho University Omori Medical Center
🇯🇵
Tokyo, Japan
Tokyo Women's Medical University
🇯🇵
Tokyo, Japan
Singapore General Hospital
🇸🇬
Singapore, Singapore
Chulalongkorn Hospital
🇹🇭
Bangkok, Thailand
Peking University Third Hospital
🇨🇳Beijing, China