Prospective, multi-center clinical study to evaluate the clinical outcomes of the posterior stabilized design of the LCS® Complete Mobile-bearing Total Knee System

Prospective, multi-center study to evaluate the clinical outcome of posterior stabilized design of LCS® Complete Mobile-Bearing Total Knee System. No comparison group. 12 month enrollment, 12 month post-operative evaluation. Follow-up intervals: Pre-op, 3 month, 6 month, and 12 month.

Inclusion Criteria:

• M/F
• 18-80
• Diagnosis of osteoarthritis, rheumatoid , post-traumatic, inflammatory, juvenile arthritis.
• Skeletally mature, sufficient bone stock to seat and support prosthesis
• Willing/able return for follow-up.
• Subject is willing and able to provide informed patient consent for participation in the study

Exclusion Criteria:

• History of recent/active joint sepsis, charcot neuropathy, psycho-social disorders, prior knee arthroplasty on affected site, metabolic disorders of calcified tissue
• Communicable diseases that may limit follow-up
• Medical-legal or workers compensation claims.

In this study adverse events were reporting for the length of the study which was one year.

There were 30 total occurrences of which 14 were unique serious adverse events that affected 28 subjects (2 subjects experienced more than 1 serious adverse event). There were 13 total occurrences of other adverse events, of which 1 unique event (above the 5% threshold) affected 11 subjects (2 subjects experienced more than 1 other adverse event).