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A Clinical Investigation of the Oxford® Partial Knee System

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.
ClinicalTrials.gov Identifier: NCT00699257
Recruitment Status : Terminated
First Posted : June 17, 2008
Last Update Posted : June 21, 2017
Sponsor:
Information provided by (Responsible Party):

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

Condition or disease
Osteoarthritis

Study Design

Study Type : Observational
Actual Enrollment : 85 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective, Non-controlled, Clinical Investigation of the Oxford® Partial Knee System
Study Start Date : July 2004
Primary Completion Date : August 2008
Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort
Oxford® Partial Knee System


Outcome Measures

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

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

Eligibility Criteria

Information from the National Library of Medicine

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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 Posted: June 17, 2008    Key Record Dates
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