NCT02440672

JOURNEY™ II CR Total Knee System

A Prospective, Non-randomized, Single Cohort, Multicenter Study to Evaluate the Clinical Outcomes of Total Knee Arthroplasty (TKA) Using the JOURNEY™ II CR Total Knee System

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 170 (actual)
• Sponsor: Smith & Nephew, Inc. · Industry
• Sex: All
• Age: 22 Years – 75 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the safety and effectiveness of the JOURNEY™ II CR Total Knee System in subjects with degenerative joint disease (DJD) requiring primary total knee replacement.

Detailed description

This is a prospective, non-randomized, single cohort, multicenter study to evaluate the clinical outcomes of TKA using the JOURNEY™ II CR Total Knee System in subjects with degenerative joint disease (DJD) requiring primary total knee replacement. One hundred and seventy (170) subjects will be enrolled at up to 18 clinical sites globally. Follow-up clinical assessments will be performed at 3 months, 1 year, 2 years, 5 years, and 10 years post-operatively.

Conditions

• Osteoarthritis, Knee

Interventions

Type	Name	Description
DEVICE	JOURNEY™ II CR Total Knee System (J II CR TKS)	TKA with Journey II CR Total Knee System

Timeline

• Start date: 2015-09-01
• Primary completion: 2028-06-01
• Completion: 2028-06-01
• First posted: 2015-05-12
• Last updated: 2025-12-17

Locations

9 sites across 3 countries: United States, Spain, United Kingdom

Regulatory

• FDA-regulated device study