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

Resource links provided by NLM:


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
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 April 22, 2014