A Clinical Investigation of the Oxford® Meniscal Unicompartmental Knee System

Completed

• Conditions: Avascular Necrosis; Osteoarthritis
• Interventions: Device: Oxford® Meniscal Unicompartmental Knee System

• Registration Number: NCT00578994
• Lead Sponsor: Biomet Orthopedics, LLC

Brief 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.

Study Timeline

• Study Start: 2006-03
• Study First Submitted: 2007-12-19
• Study First Submitted QC: 2007-12-19
• Study First Posted: 2007-12-21
• Primary Completion: 2019-12-31
• Study Completion: 2021-03-31
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-19
• Last Update Posted: 2021-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 388

Inclusion Criteria

• Patients with one of the following diagnoses in the medial compartment of the knee: Osteoarthritis, Avascular Necrosis

Exclusion Criteria

• Patients with Rheumatoid arthritis or other forms of inflammatory joint disease
• Patients with infection, sepsis, and osteomyelitis
• Patients with Osteoporosis, Paget's Disease, Charcot's disease, Osteomalacia, and Severe Osteoporosis

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Oxford® Meniscal Unicompartmental Knee	Oxford® Meniscal Unicompartmental Knee System	Patients with PKA using the Oxford® Meniscal Unicompartmental Knee System

Primary Outcome Measures

Name	Time	Method
Survivorship	Annually for 9 years post-op	Assessment of frequency of Revisions

Secondary Outcome Measures

Name	Time	Method
Complications	2 Years	Patients will be followed for at least 2 years to record all complications that may occur

Trial Locations

Locations (6)

Mid-South Orthopedic Associates; 🇺🇸 Cordova, Tennessee, United States

Barrington Orthopedic Specialissts; 🇺🇸 Schaumburg, Illinois, United States

Joint Implant Surgeons; 🇺🇸 New Albany, Ohio, United States

Texas Orthopedic Specialist; 🇺🇸 Bedford, Texas, United States

Texas Center for Joint Replacement; 🇺🇸 Plano, Texas, United States

Advanced Orthopaedic Centers; 🇺🇸 Richmond, Virginia, United States