NCT03768128

Safety and Performance of the Journey™ II UNI Unicompartmental Knee System

A Prospective, Multicenter Post-Market Clinical Follow-up Study to Evaluate the Safety and Performance of the Journey™ II UNI Unicompartmental Knee System

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 154 (actual)
• Sponsor: Smith & Nephew, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This clinical study will evaluate the early to midterm safety and performance of the JOURNEY™ II UNI UKS in patients with non-inflammatory degenerative joint disease of the knee requiring lateral or medial knee compartment replacement. Clinical, radiographic, health economic and safety outcomes will be evaluated.

Detailed description

To assess the safety and performance of the JOURNEY™ II UNI UKS in patients with unicompartmental degeneration of the knee by demonstrating non-inferiority of the cumulative percent implant survival in subjects with the JOURNEY™ II UNI UKS implanted, compared to a literature reference rate of 91.7% (AOA annual report 2015)12 at 5 years.

Conditions

• Non-inflammatory Degenerative Joint Disease (NIDJD) of the Knee

Interventions

Type	Name	Description
DEVICE	Journey™ II UNI Unicompartmental Knee System	Journey™ II UNI UKS is a CE Marked medical device. The device has been designed to treat both medial and lateral unicompartmental disease. It is a comprehensive system designed to allow surgeons to perform UKA. It is comprised of the following anatomic components: Oxidized zirconium femoral components Titanium tibial components with a grit-blasted surface Polyethylene tibial insert components The device is asymmetric and is available in oxidized zirconium to reduce wear and increase implant longevity.

Timeline

• Start date: 2018-08-10
• Primary completion: 2025-05-19
• Completion: 2025-05-19
• First posted: 2018-12-07
• Last updated: 2026-02-27

Locations

6 sites across 3 countries: United States, Italy, Poland