NCT00578994

A Clinical Investigation of the Oxford® Meniscal Unicompartmental Knee System

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 388 (actual)
• Sponsor: Biomet Orthopedics, LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Osteoarthritis
• Avascular Necrosis

Interventions

Type	Name	Description
DEVICE	Oxford® Meniscal Unicompartmental Knee System	Oxford® Meniscal Unicompartmental Knee System is a medial, unicompartmental knee prosthesis containing three components: a femoral component, a tibial component, and a tibial meniscal bearing.

Timeline

• Start date: 2006-03-01
• Primary completion: 2019-12-31
• Completion: 2021-03-31
• First posted: 2007-12-21
• Last updated: 2021-04-21

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated device study