Status:
TERMINATED
A Clinical Investigation of the Oxford® Partial Knee System
Lead Sponsor:
Biomet Orthopedics, LLC
Conditions:
Osteoarthritis
Eligibility:
All Genders
Brief Summary
The purpose of this prospective data collection is to document the performance and clinical outcomes of the Oxford® Partial Knee System.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2004
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
85 Patients enrolled
Trial Details
Trial ID
NCT00699257
Start Date
July 1 2004
End Date
December 1 2008
Last Update
June 21 2017
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