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

2018-12-13 02:49:11 | BioPortfolio

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.

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.

Study Design

Conditions

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

Intervention

Journey™ II UNI Unicompartmental Knee System

Location

Midwest Ortho at Rush
Chicago
Illinois
United States
60612

Status

Recruiting

Source

Smith & Nephew, Inc.

Results (where available)

View Results

Links

Published on BioPortfolio: 2018-12-13T02:49:11-0500

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Medical and Biotech [MESH] Definitions

Noninflammatory degenerative disease of the knee joint consisting of three large categories: conditions that block normal synchronous movement, conditions that produce abnormal pathways of motion, and conditions that cause stress concentration resulting in changes to articular cartilage. (Crenshaw, Campbell's Operative Orthopaedics, 8th ed, p2019)

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A region of the lower extremity immediately surrounding and including the KNEE JOINT.

Replacement for a knee joint.

Injuries to the knee or the knee joint.

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