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A Clinical Investigation of the Oxford® Partial Knee System

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00699257
First Posted: June 17, 2008
Last Update Posted: June 21, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Zimmer Biomet ( Biomet Orthopedics, LLC )
  Purpose
The purpose of this prospective data collection is to document the performance and clinical outcomes of the Oxford® Partial Knee System.

Condition
Osteoarthritis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective, Non-controlled, Clinical Investigation of the Oxford® Partial Knee System

Resource links provided by NLM:


Further study details as provided by Zimmer Biomet ( Biomet Orthopedics, LLC ):

Primary Outcome Measures:
  • Knee Society Score [ Time Frame: 6 weeks, 3 months, 1 year, 3 years, 5 years ]
  • Oxford-12 Self Assessment Form [ Time Frame: 6 weeks, 3 months, 1 year, 3 years, 5 years ]

Secondary Outcome Measures:
  • Incidence of revisions and removals [ Time Frame: Any time ]

Enrollment: 85
Study Start Date: July 2004
Study Completion Date: December 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
Oxford® Partial Knee System

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
ClinicalTrials.gov Identifier: NCT00699257     History of Changes
Other Study ID Numbers: Biomet 12380-63
First Submitted: June 13, 2008
First Posted: June 17, 2008
Last Update Posted: June 21, 2017
Last Verified: June 2017

Keywords provided by Zimmer Biomet ( Biomet Orthopedics, LLC ):
Partial Knee Arthroplasty
Partial Knee Replacement
Arthritis of Medial Compartment of the Knee
Oxford Knee

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases