A Clinical Investigation of the Oxford® Partial Knee System

Terminated

• Conditions: Osteoarthritis

• Registration Number: NCT00699257
• Lead Sponsor: Biomet Orthopedics, LLC

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2004-07
• Study First Submitted: 2008-06-13
• Study First Submitted QC: 2008-06-13
• Study First Posted: 2008-06-17
• Primary Completion: 2008-08
• Study Completion: 2008-12
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-19
• Last Update Posted: 2017-06-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 85

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Knee Society Score	6 weeks, 3 months, 1 year, 3 years, 5 years
Oxford-12 Self Assessment Form	6 weeks, 3 months, 1 year, 3 years, 5 years

Secondary Outcome Measures

Name	Time	Method
Incidence of revisions and removals	Any time