A Clinical Investigation of the Oxford® Partial Knee System

Zimmer Biomet

Status: Terminated

Conditions: Osteoarthritis

Study type: Observational

Funder types: Industry

Identifiers

NCT00699257

Biomet 12380-63

Details and patient eligibility

About

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

Enrollment: 85 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

85 participants in 1 patient group

Oxford® Partial Knee System