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Clinical Trials/NCT00699257
NCT00699257
Terminated
N/A

A Prospective, Non-controlled, Clinical Investigation of the Oxford® Partial Knee System

Biomet Orthopedics, LLC0 sites85 target enrollmentJuly 2004
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ConditionsOsteoarthritis

Overview

Phase
N/A
Intervention
Not specified
Conditions
Osteoarthritis
Sponsor
Biomet Orthopedics, LLC
Enrollment
85
Primary Endpoint
Knee Society Score
Status
Terminated
Last Updated
8 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

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

Registry
clinicaltrials.gov
Start Date
July 2004
End Date
December 2008
Last Updated
8 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility 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

Outcomes

Primary Outcomes

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 Outcomes

  • Incidence of revisions and removals(Any time)

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