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

Purpose

The purpose of this prospective data collection is to document the performance and clinical outcomes of the Oxford® Partial Knee System.

Condition

Osteoarthritis

MedlinePlus related topics:

Osteoarthritis

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective

Official Title:	A Prospective, Non-Controlled, Clinical Investigation of the Oxford® Partial Knee System

Further study details as provided by Biomet, Inc.:

Primary Outcome Measures:

Knee Society Score [ Time Frame: 6 weeks, 3 months, 1 year, 3 years, 5 years ] [ Designated as safety issue: No ]
Oxford-12 Self Assessment Form [ Time Frame: 6 weeks, 3 months, 1 year, 3 years, 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Incidence of revisions and removals [ Time Frame: Any time ] [ Designated as safety issue: Yes ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	500
Study Start Date:	July 2004
Estimated Study Completion Date:	June 2014
Estimated Primary Completion Date:	June 2014 (Final data collection date for primary outcome measure)

Oxford® Partial Knee System

Eligibility

Study Population

Patients that have already made the decision to undergo knee surgery and will receive the Oxford® Partial Knee System.

Criteria

Inclusion Criteria:

For use in individuals with osteoarthritis or avascular necrosis limited to the medial compartment of the knee. The implant is intended to be implanted with bone cement.

Exclusion Criteria:

Infection
Use in the lateral compartment of the knee
Rheumatoid arthritis or other forms of inflammatory joint disease
Revision of a failed prosthesis, failed upper tibial osteotomy or post-traumatic arthritis after tibial plateau fracture
Insufficiency of the collateral, anterior, or posterior cruciate ligaments which would preclude stability of the device
Disease or damage to the lateral compartment of the knee
Uncooperative patient or patient with neurologic disorders who is incapable of following directions
Osteoporosis
Metabolic disorders which may impair bone formation
Osteomalacia
Distant foci of infections which may spread to the implant site
Rapid joint destruction, marked bone loss, or bone resorption apparent on roentgenogram
Vascular insufficiency, muscular atrophy, neuromuscular disease
Incomplete or deficient soft tissue surrounding the knee
Charcot's disease
A fixed varus deformity (not passively correctable) of greater than 15 degrees
A flexion deformity greater than 15 degrees

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00699257

Sponsors and Collaborators

Biomet Orthopedics, LLC

Investigators


Study Director:	Kenneth J Beres, MD	Clinical Research, Biomet Orthopedics, LLC

More Information

Responsible Party:	Biomet Orthopedics, LLC ( Kenneth Beres, MD Director Clinical Research )
Study ID Numbers:	Biomet 12380-63
First Received:	June 13, 2008
Last Updated:	July 21, 2008
ClinicalTrials.gov Identifier:	NCT00699257
Health Authority:	United States: Institutional Review Board

Keywords provided by Biomet, Inc.:

Partial Knee Arthroplasty

Partial Knee Replacement

Arthritis of Medial Compartment of the Knee

Oxford Knee

Study placed in the following topic categories:

Musculoskeletal Diseases

Osteoarthritis

Joint Diseases

Arthritis

Rheumatic Diseases

ClinicalTrials.gov processed this record on October 10, 2008

Sponsored by:	Biomet Orthopedics, LLC
Information provided by:	Biomet, Inc.
ClinicalTrials.gov Identifier:	NCT00699257