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

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

Background:

The JOURNEY II BCS Total Knee System (JOURNEY II Bi-cruciate Stabilized Total Knee System) consists of femoral component made from oxidized zirconium (OXINIUM)

The JOURNEY II CR Total Knee System (JOURNEY II Cruciate Retaining Total Knee System ) consists of femoral component made from oxidized zirconium (OXINIUM)

Purpose:

Post-market evidence generation for JOURNEY II BCS and JOURNEY II CR Total Knee System

Objectives:

1. Evaluate the performance of JOURNEY II TKA in Asia-Pacific (APAC) patient populations
2. Establish the equivalent performance between JOURNEY II BCS and JOURNEY II CR to support adoption of JOURNEY II CR

Research participants / locations:

A total of at least 176 knees' information will be collected in up to 10 sites. There will be at least eighty-eight (88) knees for JOURNEY II CR TKA group and at least 88 knees for JOURNEY II BCS TKA group.

Study Overview

• Status: Withdrawn
• Conditions: Arthroplasty; Knee; Replacement
• Intervention / Treatment: Device: JOURNEY II BCS Total Knee System; Device: JOURNEY II CR Total Knee System

• Study Type: Interventional
• Phase: Not Applicable

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, 411001
      • Noble Hospital & Ruby Hall Clinic
• Singapore
  • Singapore, Singapore, 169608
    • Singapore General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subjects with degenerative osteoarthritis.
• Subject is planning to have bilateral Total Knee Arthroplasty (TKA) using JOURNEY II BCS & CR or have unilateral TKA using JOURNEY II BCS or JOURNEY II CR.*
• Subject is able and willing to provide voluntary consent to study participation.
• Subject is 18-80 years old (inclusive).

[* Bilateral cases can be simultaneous bilateral or staged bilateral (which an interval of 6-8 weeks apart between both knees)]

Exclusion Criteria:

• Subjects with rheumatoid arthritis/inflammatory arthritis, posttraumatic arthritis.
• Previous surgeries including High Tibial Osteotomy (HTO), Unicondylar Knee Arthroplasty (UKA) or Total Knee Arthroplasty (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 BCS & JOURNEY II CR's Instructions For Use (IFU).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: JOURNEY II BCS TKA; Undergoing Total Knee Replacement(resurfaced patella) with JOURNEY II BCS Total Knee System	Device: JOURNEY II BCS Total Knee System; Undergoing Total Knee Replacement(resurfaced patella) with JOURNEY II BCS Total Knee System
EXPERIMENTAL: JOURNEY II CR TKA; Undergoing Total Knee Replacement(resurfaced patella) with JOURNEY II CR Total Knee System	Device: JOURNEY II CR Total Knee System; Undergoing Total Knee Replacement(resurfaced patella) with JOURNEY II CR Total Knee System

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 (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.	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 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
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 (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.	Pre-Operative, 6 months, 1 year, 3 years
Patient Expectation	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.	Pre-Operative
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 electronic Case Report Form (eCRF).	Pre-Operative, 6 months, 1 year, 2 years, 3 years
Timed Up and Go Test (TUG)	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	Pre-Operative, Immediate Post -op to 6 weeks, 6 months, 1 year
Star Excursion Balance Test (SEBT)	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.	Pre-Operative, Immediate Post -op to 6 weeks, 6 months, 1 year

Collaborators and Investigators

• Sponsor: Smith & Nephew, Inc.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): August 28, 2022
• Primary Completion (ANTICIPATED): December 31, 2022
• Study Completion (ANTICIPATED): December 31, 2025

Study Registration Dates

• First Submitted: March 26, 2021
• First Submitted That Met QC Criteria: March 26, 2021
• First Posted (ACTUAL): March 30, 2021

Study Record Updates

• Last Update Posted (ACTUAL): June 7, 2022
• Last Update Submitted That Met QC Criteria: June 2, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: Osteoarthritis; Total knee arthroplasty (TKA); Cruciate Retaining (CR); Bi-cruciate Stabilized (BCS)
• Other Study ID Numbers: Journey II CR + BCS.2020.12

Plan for Individual participant data (IPD)

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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes