A Clinical Investigation of the Oxford® Meniscal Unicompartmental Knee System

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Biomet, Inc. ( Biomet Orthopedics, LLC )

ClinicalTrials.gov Identifier:

NCT00578994

First received: December 19, 2007

Last updated: February 11, 2012

Last verified: February 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	December 19, 2007
Last Updated Date	February 11, 2012
Start Date ^ICMJE	March 2006
Estimated Primary Completion Date	December 2016 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: December 19, 2007)	Complications, Survival [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00578994 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	A Clinical Investigation of the Oxford® Meniscal Unicompartmental Knee System
Official Title ^ICMJE	A Prospective, Non-randomized, Multicenter Study of the Oxford® Meniscal Unicompartmental Knee System
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	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Osteoarthritis Avascular Necrosis
Intervention ^ICMJE	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.
Study Arm (s)	Oxford® Meniscal Unicompartmental Knee Recipients Intervention: Device: Oxford® Meniscal Unicompartmental Knee System
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Enrollment ^ICMJE	388
Estimated Completion Date	December 2017
Estimated Primary Completion Date	December 2016 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00578994
Other Study ID Numbers ^ICMJE	201-U-008
Has Data Monitoring Committee	Yes
Responsible Party	Biomet, Inc. ( Biomet Orthopedics, LLC )
Study Sponsor ^ICMJE	Biomet Orthopedics, LLC
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Biomet, Inc.
Verification Date	February 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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