Evaluate the Performance of JOURNEY II CR in TKA Populations

Arthroplasty Clinical Trial

— JIICRTKA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04818840
• Other study ID #: Journey II CR.2020.11
• Status: Recruiting
• Start date: March 3, 2022
• Est. completion date: May 31, 2028

Study information

• Verified date: October 2023
• Source: Smith & Nephew, Inc.
• Contact: Cathy Xiao
• Phone: +86 18221637315
• Email: Cathy.xiao[@]smith-nephew.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 480
• Est. completion date: May 31, 2028
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Arthroplasty
• Knee
• Replacement

Intervention

Device:
• Resurfaced Patella
JOURNEY II CR Total Knee System was used for Total Knee replacement

Procedure:
• Un-resurfaced Patella
JOURNEY II CR Total Knee System was used for Total Knee replacement

Locations

Country	Name	City	State
China	Peking University Third Hospital	Beijing
China	Prince of Wales Hospital	Hong Kong
India	Aster RV Hospital, Bangalore	Bengaluru	Karnataka
India	Arcus Hospital	Pune	Maharashtra
Japan	Toho University Omori Medical Center	Tokyo
Japan	Tokyo Women's Medical University	Tokyo
Singapore	Singapore General Hospital	Singapore
Thailand	Chulalongkorn Hospital	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Smith & Nephew, Inc.

Countries where clinical trial is conducted

China,  India,  Japan,  Singapore,  Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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