NCT04822259

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

A Prospective Multi-Centre Study in Patients Undergoing Total Knee Replacement With JOURNEY II BCS and CR Total Knee System

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Smith & Nephew, Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2022-08-28
• Primary completion: 2022-12-31
• Completion: 2025-12-31
• First posted: 2021-03-30
• Last updated: 2022-06-07

Locations

5 sites across 3 countries: China, India, Singapore

Regulatory

• FDA-regulated device study