A Clinical Investigation of the Oxford® Meniscal Unicompartmental Knee System

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

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.

Study Overview

• Status: Completed
• Conditions: Osteoarthritis; Avascular Necrosis
• Intervention / Treatment: Device: Oxford® Meniscal Unicompartmental Knee System

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 Type: Observational
• Enrollment (Actual): 388

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Schaumburg, Illinois, United States, 60195
      • Barrington Orthopedic Specialissts
  • Ohio
    • New Albany, Ohio, United States, 43054
      • Joint Implant Surgeons
  • Tennessee
    • Cordova, Tennessee, United States, 38018
      • Mid-South Orthopedic Associates
  • Texas
    • Bedford, Texas, United States, 76021
      • Texas Orthopedic Specialist
    • Plano, Texas, United States, 75093
      • Texas Center for Joint Replacement
  • Virginia
    • Richmond, Virginia, United States, 23294
      • Advanced Orthopaedic Centers

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

A Multi-center study conducted in the United States of patients who meet the FDA approved indications for use. The Oxford Meniscal Unicompartmental Knee System is intended for use in individuals with osteoarthritis or avascular necrosis limited to the medial compartment of the knee and is intended to be implanted with bone cement.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Oxford® Meniscal Unicompartmental Knee; Patients with PKA using the Oxford® Meniscal Unicompartmental Knee System	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survivorship	Assessment of frequency of Revisions	Annually for 9 years post-op

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complications	Patients will be followed for at least 2 years to record all complications that may occur	2 Years

Collaborators and Investigators

• Sponsor: Biomet Orthopedics, LLC
• Investigators: Study Director: Kacy Arnold, kacy.arnold@zimmerbiomet.com

Study record dates

Study Major Dates

• Study Start: March 1, 2006
• Primary Completion (Actual): December 31, 2019
• Study Completion (Actual): March 31, 2021

Study Registration Dates

• First Submitted: December 19, 2007
• First Submitted That Met QC Criteria: December 19, 2007
• First Posted (Estimate): December 21, 2007

Study Record Updates

• Last Update Posted (Actual): April 21, 2021
• Last Update Submitted That Met QC Criteria: April 19, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Knee arthroplasty; Unicompartmental Knee; Partial Knee
• Additional Relevant MeSH Terms: Pathologic Processes; Necrosis
• Other Study ID Numbers: ORTHO.CR.K016; P010014 (Other Identifier: FDA PMA)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes