A Clinical Investigation of the Oxford® Meniscal Unicompartmental Knee System

Osteoarthritis Clinical Trial

Official title: A Prospective, Non-randomized, Multicenter Study of the Oxford® Meniscal Unicompartmental Knee System

Status Completed

Clinical Trial Summary

The purpose of this study is to collect information on complications and survivorship of patients implanted with the Oxford™ Meniscal Unicompartmental Knee System at multiple sites in the United States.

Clinical Trial Description

Study Objective

To provide a prospective 2-year post-operative evaluation of complications and 9-year long-term survivorship analysis of patients implanted with the Oxford™ Meniscal Unicompartmental Knee System at multiple sites in the United States.

Study Design

The study is designed as a prospective, multi-center, non-randomized post approval study. There are two phases to this study:

1. A complications study where patients will be followed for at least 2 years to record all complications that may occur, and

2. A survival study that will record at yearly intervals out to 9 years whether or not the device is still in place or if it has been removed for any reason.

Phase 1 requires clinical follow-up (0-2 year) and patients will be evaluated at pre-defined intervals up to 2 years post-operative. Information gathered in phase 1 includes all adverse events and survival data.

Phase 2 (3-9 year) only gathers survival data through patient directed mailing and/or phone call. ;

Related Conditions & MeSH terms

• Avascular Necrosis
• Necrosis
• Osteoarthritis

• NCT number: NCT00578994
• Study type: Observational
• Source: Zimmer Biomet
• Status: Completed
• Start date: March 2006
• Completion date: March 31, 2021