A Clinical Investigation of the Oxford® Meniscal Unicompartmental Knee System - Full Text View

A Clinical Investigation of the Oxford® Meniscal Unicompartmental Knee System

This study is currently recruiting participants.
Verified by Biomet, Inc., July 2008

Sponsored by:	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

MedlinePlus related topics:

Osteoarthritis Osteonecrosis

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment

Official Title:	A Prospective, Non-Randomized, Multicenter Study of the Oxford® Meniscal Unicompartmental Knee System

Further study details as provided by Biomet, Inc.:

Primary Outcome Measures:

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

Estimated Enrollment:	389
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
I	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

Contacts


Contact: Tracy Johnson	1-800-348-9500	tracy.johnson@biometmail.com

Contact: Jarsie Weeks	1-800-348-9500	jarsie.weeks@biomet.com

Locations


United States, Indiana
	Biomet Orthopedics, LLC	Recruiting
	Warsaw, Indiana, United States, 46581
	Contact: Jarsie Weeks 800-348-9500 jarsie.weeks@biomet.com

Sponsors and Collaborators

Biomet Orthopedics, LLC

More Information

Responsible Party:	Biomet Orthopedics, LLC ( Tracy Johnson )
Study ID Numbers:	201-U-008
First Received:	December 19, 2007
Last Updated:	July 3, 2008
ClinicalTrials.gov Identifier:	NCT00578994
Health Authority:	United States: Food and Drug Administration

Keywords provided by Biomet, Inc.:

Unicompartmental Knee

Partial Knee

Knee arthroplasty

Study placed in the following topic categories:

Necrosis

Musculoskeletal Diseases

Osteonecrosis

Osteoarthritis

Joint Diseases

Arthritis

Rheumatic Diseases

Bone Diseases

Additional relevant MeSH terms:

Pathologic Processes

ClinicalTrials.gov processed this record on October 10, 2008