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

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

Study Type: Observational

Study Design: Cohort, Prospective

Study Primary Completion Date: August 2008

Arms, Groups and Cohorts in this Clinical Trial

• : Oxford® Partial Knee System

Primary Measures

• Knee Society Score
  • Time Frame: 6 weeks, 3 months, 1 year, 3 years, 5 years
    Safety Issue?: No
• Oxford-12 Self Assessment Form
  • Time Frame: 6 weeks, 3 months, 1 year, 3 years, 5 years
    Safety Issue?: No

Secondary Measures

• Incidence of revisions and removals
  • Time Frame: Any time
    Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: N/A

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Biomet Orthopedics, LLC

Overall Clinical Trial Officials and Contacts

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

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00699257

Study ID Number: Biomet 12380-63

ClinicalTrials.gov Identifier: NCT00699257

Health Authority: United States: Institutional Review Board