Evaluate the Performance of JOURNEY II CR in TKA Populations (JIICRTKA)

Smith & Nephew

Status

Terminated

Conditions

Arthroplasty

Knee

Replacement

Treatments

Device: Resurfaced Patella

Procedure: Un-resurfaced Patella

Study type

Observational

Funder types

Industry

Identifiers

NCT04818840

Journey II CR.2020.11

Details and patient eligibility

About

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.

Enrollment

62 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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.