Randomized Fixed Bearing vs Mobile Bearing Cruciate Substituting TKA

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

The study will evaluate the clinical performance of the rotating platform and fixed bearing implants through patient questionnaires, outcomes scoring and radiographic assessment.

The study will evaluate the clinical performance of rotating platform and fixed bearing cruciate ligament substituting implants by obtaining a series of primary TKAS. Patients will receive either the P.F.C.® Sigma™ Rotating Platform Cruciate Substituting Knee System or P.F.C.® Sigma™ Fixed Cruciate Substituting Knee System and assignment is randomized.

Inclusion Criteria:

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

Exclusion Criteria:

• 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.
• Prior ipsilateral knee arthroplasty.
• Metabolic disorders of calcified tissues, such as Paget's disease.
• Severe diabetes mellitus.
• Joint replacement due to autoimmune disorders.
• Skeletal immaturity