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: July 14, 2014
Last verified: March 2014
  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: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective, Non-randomized, Multicenter Study of the Oxford® Meniscal Unicompartmental Knee System

Resource links provided by NLM:


Further study details as provided by Biomet, Inc.:

Primary Outcome Measures:
  • Survivorship [ Time Frame: Annually for 9 years post-op ] [ Designated as safety issue: Yes ]
    Assessment of frequency of Revisions


Secondary Outcome Measures:
  • Complications [ Time Frame: 2 Years ] [ Designated as safety issue: Yes ]
    Patients will be followed for at least 2 years to record all complications that may occur


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)
Groups/Cohorts Assigned Interventions
Oxford® Meniscal Unicompartmental Knee
Patients with PKA using the Oxford® Meniscal Unicompartmental Knee System
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.

Detailed Description:

Study Objective

To provide a prospective 2-year post-operative evaluation of complications and 9-year long-term survivorship analysis of patients implanted with the Oxford™ Meniscal Unicompartmental Knee System at multiple sites in the United States.

Study Design

The study is designed as a prospective, multi-center, non-randomized post approval study. There are two phases to this study:

  1. A complications study where patients will be followed for at least 2 years to record all complications that may occur, and
  2. A survival study that will record at yearly intervals out to 9 years whether or not the device is still in place or if it has been removed for any reason.

Phase 1 requires clinical follow-up (0-2 year) and patients will be evaluated at pre-defined intervals up to 2 years post-operative. Information gathered in phase 1 includes all adverse events and survival data.

Phase 2 (3-9 year) only gathers survival data through patient directed mailing and/or phone call.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

A Multi-center study conducted in the United States of patients who meet the FDA approved indications for use. The Oxford Meniscal Unicompartmental Knee System is intended for use in individuals with osteoarthritis or avascular necrosis limited to the medial compartment of the knee and is intended to be implanted with bone cement.

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Investigators
Study Director: Russell Schenck, Ph.D. Biomet, Inc.
  More Information

No publications provided

Responsible Party: Biomet, Inc. ( Biomet Orthopedics, LLC )
ClinicalTrials.gov Identifier: NCT00578994     History of Changes
Other Study ID Numbers: ORTHO.CR.K016, P010014
Study First Received: December 19, 2007
Last Updated: July 14, 2014
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 August 28, 2014