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

Smith & Nephew

Status: Withdrawn

Conditions: Arthroplasty; Knee; Replacement

Treatments: Device: JOURNEY II BCS Total Knee System; Device: JOURNEY II CR Total Knee System

Study type: Interventional

Funder types: Industry

Identifiers

NCT04822259

Journey II CR + BCS.2020.12

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

JOURNEY II BCS TKA

Experimental group

Description:

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

Treatment:

Device: JOURNEY II BCS Total Knee System

JOURNEY II CR TKA

Experimental group

Description:

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

Treatment:

Device: JOURNEY II CR Total Knee System