NCT04822259

Brief Summary

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

Trial Health

33
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Aug 2022

Longer than P75 for not_applicable

Geographic Reach
3 countries

5 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 26, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 30, 2021

Completed
1.4 years until next milestone

Study Start

First participant enrolled

August 28, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

June 7, 2022

Status Verified

June 1, 2022

Enrollment Period

4 months

First QC Date

March 26, 2021

Last Update Submit

June 2, 2022

Conditions

ArthroplastyReplacementKnee

Keywords

OsteoarthritisTotal knee arthroplasty (TKA)Cruciate Retaining (CR)Bi-cruciate Stabilized (BCS)

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (8)

  • 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)

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

  • Patient Expectation

    Pre-Operative

  • Patient Satisfaction

    6 months, 1 year, 2 years, 3 years

  • +3 more secondary outcomes

Study Arms (2)

JOURNEY II BCS TKA

EXPERIMENTAL

Undergoing Total Knee Replacement(resurfaced patella) with JOURNEY II BCS Total Knee System

Device: JOURNEY II BCS Total Knee System

JOURNEY II CR TKA

EXPERIMENTAL

Undergoing Total Knee Replacement(resurfaced patella) with JOURNEY II CR Total Knee System

Device: JOURNEY II CR Total Knee System

Interventions

JOURNEY II BCS Total Knee SystemDEVICE

Undergoing Total Knee Replacement(resurfaced patella) with JOURNEY II BCS Total Knee System

JOURNEY II BCS TKA
JOURNEY II CR Total Knee SystemDEVICE

Undergoing Total Knee Replacement(resurfaced patella) with JOURNEY II CR Total Knee System

JOURNEY II CR TKA

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

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

Noble Hospital & Ruby Hall Clinic

Pune, Maharashtra, 411001, India

Location

Singapore General Hospital

Singapore, 169608, Singapore

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Astrid Yung

    Smith & Nephew, Inc.

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 26, 2021

First Posted

March 30, 2021

Study Start

August 28, 2022

Primary Completion

December 31, 2022

Study Completion

December 31, 2025

Last Updated

June 7, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations

SG(1)CN(2)IN(2)