Primary TKA Cruciate Retaining vs Cruciate Substituting With Rotating Platform Knee Prostheses

Multi-center Prospective Clinical Evaluation of the P.F.C.® Sigma™ Rotating Platform Knee Primary Cases Cruciate Retaining Versus Cruciate Substituting

The purpose of the study is to evaluate the clinical performance of the cruciate ligament retaining or cruciate ligament substituting implants by obtaining a series of primary TKAs. Outcome scoring and radiographic assessment will be the methods used to evaluate performance.

The study will evaluate the clinical performance of cruciate ligament retaining or cruciate ligament substituting implants through a series of primary TKAs. Patients will receive either the P.F.C.® Sigma™ Rotating Platform Cruciate Retaining Knee implant or the P.F.C.® Sigma™ Rotating Platform Cruciate Substituting Knee implant and assignment will be randomized.

Inclusion Criteria:

• Osteoarthritis
• Rheumatoid arthritis
• Avascular necrosis (AVN) of bone
• Other inflammatory arthritis
• Post-traumatic arthritis
• Juvenile rheumatoid arthritis

Exclusion Criteria:

• Prior ipsilateral TKA
• Metabolic disorders
• Joint replacement due to autoimmune disorders
• History of recent/active joint sepsis
• Charcot neuropathy
• Psycho-social disorders that would limit rehabilitation
• Greater than 75 years of age at the time of surgery
• Severe diabetes mellitus
• Skeletal immaturity