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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
  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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective, Non-randomized, Multicenter Study of the Oxford® Meniscal Unicompartmental Knee System

Resource links provided by NLM:

MedlinePlus related topics: Osteoarthritis
U.S. FDA Resources

Further study details as provided by Biomet, Inc.:

Primary Outcome Measures:
  • Complications, Survival [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]

Enrollment: 388
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
Oxford® Meniscal Unicompartmental Knee Recipients 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

Locations
United States, Indiana
Biomet Orthopedics, LLC
Warsaw, Indiana, United States, 46581
Sponsors and Collaborators
Biomet Orthopedics, LLC
  More Information

No publications provided

Responsible Party: Biomet, Inc. ( Biomet Orthopedics, LLC )
ClinicalTrials.gov Identifier: NCT00578994     History of Changes
Other Study ID Numbers: 201-U-008
Study First Received: December 19, 2007
Last Updated: February 11, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Biomet, Inc.:
Unicompartmental Knee
Partial Knee
Knee arthroplasty

Additional relevant MeSH terms:
Necrosis
Osteonecrosis
Osteoarthritis
Pathologic Processes
Bone Diseases
 Musculoskeletal Diseases
Arthritis
Joint Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on May 16, 2013