A Clinical Investigation of the Oxford® Meniscal Unicompartmental Knee System

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

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.

Intervention(s) in this Clinical Trial

• 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.

Arms, Groups and Cohorts in this Clinical Trial

• Other: Oxford® Meniscal Unicompartmental Knee Recipients

Primary Measures

• Complications, Survival
  • Time Frame: 10 years
    Safety Issue?: Yes

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 Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Biomet Orthopedics, LLC Industry

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00578994

Study ID Number: 201-U-008

ClinicalTrials.gov Identifier: NCT00578994

Health Authority: United States: Food and Drug Administration