Evaluate the Performance of JOURNEY II CR in TKA Populations

NCT04818840 | Terminated Results

• 1 other identifier: Journey II CR.2020.11
• Study Type: observational
• Target: 62
• Locations: 5 countries
• Sites: 8

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.

Conditions

Arthroplasty; Replacement; Knee

Keywords

Osteoarthritis; Total knee arthroplasty (TKA)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (19)

• Forgotten Joint Score (FJS)

  6 months, 1 year, 2 years, 3 years

• Oxford Knee Score (OKS)

  Pre-Operative, 6 months, 1 year, 3 years

• Knee Society Score (KSS): "Objective" Knee Score

  Pre-Operative, 6 months, 1 year, 2 years, 3 years

• Knee Society Score (KSS): Patient Satisfaction Score

  Pre-Operative, 6 months, 1 year, 2 years, 3 years

• Knee Society Score (KSS): Patient Expectation Score

  Pre-Operative, 6 months, 1 year, 2 years, 3 years

Study Arms (2)

Resurfaced/non patella

Undergoing Total Knee Replacement with JOURNEY II CR Total Knee System

Device: Resurfaced Patella

un-resurfaced patella

Undergoing Total Knee Replacement with JOURNEY II CR Total Knee System

Procedure: Un-resurfaced Patella

Interventions

Resurfaced Patella DEVICE

JOURNEY II CR Total Knee System was used for Total Knee replacement

Resurfaced/non patella

Un-resurfaced Patella PROCEDURE

JOURNEY II CR Total Knee System was used for Total Knee replacement

un-resurfaced patella

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Smith & Nephew, Inc.: lead

Study Sites (8)

Peking University Third Hospital

Beijing, 100083, China

Location

Prince of Wales Hospital

Hong Kong, China

Location

Aster RV Hospital, Bangalore

Bengaluru, Karnataka, 560078, India

Location

Arcus Hospital

Pune, Maharashtra, 411040, India

Location

Toho University Omori Medical Center

Tokyo, 1438540, Japan

Location

Tokyo Women's Medical University

Tokyo, 1628666, Japan

Location

Singapore General Hospital

Singapore, 169608, Singapore

Location

Chulalongkorn Hospital

Bangkok, 10330, Thailand

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Results Point of Contact

• Title: Senior Manager Clinical Compliance
• Organization: Smith+Nephew, Inc

datasharing.gcs@smith-nephew.com

+44 7811 407089

Study Officials

• Julian Yang

  Smith & Nephew, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2021
• First Posted: March 26, 2021
• Study Start: March 3, 2022
• Primary Completion: March 15, 2024
• Study Completion: March 15, 2024
• Last Updated: August 20, 2025
• Results First Posted: August 20, 2025

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1); IN (2); JP (2); SG (1); CN (2)