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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00578994
• Other study ID #: ORTHO.CR.K016
• Secondary ID: P010014
• Status: Completed
• Start date: March 2006
• Est. completion date: March 31, 2021

Study information

• Verified date: April 2021
• Source: Zimmer Biomet
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 388
• Est. completion date: March 31, 2021
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Avascular Necrosis
• Necrosis
• Osteoarthritis

Intervention

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.

Locations

Country	Name	City	State
United States	Texas Orthopedic Specialist	Bedford	Texas
United States	Mid-South Orthopedic Associates	Cordova	Tennessee
United States	Joint Implant Surgeons	New Albany	Ohio
United States	Texas Center for Joint Replacement	Plano	Texas
United States	Advanced Orthopaedic Centers	Richmond	Virginia
United States	Barrington Orthopedic Specialissts	Schaumburg	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Biomet Orthopedics, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survivorship	Assessment of frequency of Revisions	Annually for 9 years post-op
Secondary	Complications	Patients will be followed for at least 2 years to record all complications that may occur	2 Years