A Clinical Investigation of the Oxford® Partial Knee System

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Biomet, Inc. ( Biomet Orthopedics, LLC )
ClinicalTrials.gov Identifier:
NCT00699257
First received: June 13, 2008
Last updated: June 27, 2012
Last verified: June 2012
  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

Further study details as provided by Biomet, Inc.:

Primary Outcome Measures:
  • Knee Society Score [ Time Frame: 6 weeks, 3 months, 1 year, 3 years, 5 years ] [ Designated as safety issue: No ]
  • Oxford-12 Self Assessment Form [ Time Frame: 6 weeks, 3 months, 1 year, 3 years, 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence of revisions and removals [ Time Frame: Any time ] [ Designated as safety issue: Yes ]

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

Genders Eligible for Study:   Both
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
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: NCT00699257

Sponsors and Collaborators
Biomet Orthopedics, LLC
Investigators
Study Director: Kenneth J Beres, MD Clinical Research, Biomet Orthopedics, LLC
  More Information

No publications provided

Responsible Party: Biomet, Inc. ( Biomet Orthopedics, LLC )
ClinicalTrials.gov Identifier: NCT00699257     History of Changes
Other Study ID Numbers: Biomet 12380-63
Study First Received: June 13, 2008
Last Updated: June 27, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Biomet, Inc.:
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

ClinicalTrials.gov processed this record on October 20, 2014