A Clinical Investigation of the Oxford® Meniscal Unicompartmental Knee System

This study is ongoing, but not recruiting participants.

First Received: December 19, 2007 Last Updated: January 14, 2010 History of Changes

Sponsor:	Biomet Orthopedics, LLC
Information provided by:	Biomet, Inc.
ClinicalTrials.gov Identifier:	NCT00578994

Purpose

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.

Condition	Intervention
Osteoarthritis Avascular Necrosis	Device: Oxford® Meniscal Unicompartmental Knee System

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Prospective, Non-randomized, Multicenter Study of the Oxford® Meniscal Unicompartmental Knee System

Resource links provided by NLM:

MedlinePlus related topics: Osteoarthritis Osteonecrosis

U.S. FDA Resources

Further study details as provided by Biomet, Inc.:

Primary Outcome Measures:

Complications, Survival [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]

Enrollment:	388
Study Start Date:	March 2006
Estimated Study Completion Date:	December 2017
Estimated Primary Completion Date:	December 2016 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Oxford® Meniscal Unicompartmental Knee Recipients	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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00578994

Locations

United States, Indiana
Biomet Orthopedics, LLC
Warsaw, Indiana, United States, 46581

Sponsors and Collaborators

Biomet Orthopedics, LLC

More Information

No publications provided

Responsible Party:	Biomet Orthopedics, LLC ( Tracy Johnson )
Study ID Numbers:	201-U-008
Study First Received:	December 19, 2007
Last Updated:	January 14, 2010
ClinicalTrials.gov Identifier:	NCT00578994 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Biomet, Inc.:

Unicompartmental Knee
Partial Knee
Knee arthroplasty

Additional relevant MeSH terms:

Necrosis
Pathologic Processes
Musculoskeletal Diseases
Osteonecrosis
Osteoarthritis

Joint Diseases
Arthritis
Rheumatic Diseases
Bone Diseases

ClinicalTrials.gov processed this record on March 18, 2010