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

NCT04822259 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2022-06-07

No results posted yet for this study

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. 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.

Conditions

  • Arthroplasty
  • Replacement
  • Knee

Interventions

DEVICE

JOURNEY II BCS Total Knee System

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

DEVICE

JOURNEY II CR Total Knee System

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

Sponsors & Collaborators

  • Smith & Nephew, Inc.

    lead INDUSTRY

Principal Investigators

  • Astrid Yung · Smith & Nephew, Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-28
Primary Completion
2022-12-31
Completion
2025-12-31
FDA Device
Yes

Countries

  • China
  • India
  • Singapore

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04822259 on ClinicalTrials.gov