LEGION Hinge Safety and Efficacy Study

Inclusion Criteria

• •Subject has gross knee instability resulting from loss of collateral ligament function, gross bone loss, comminuted fractures of the proximal tibia or distal femur, rheumatoid arthritis, post-traumatic arthritis, osteoarthritis, degenerative arthritis, failed osteotomies, unicompartmental replacement or total knee replacement, or absent or incompetent posterior cruciate ligament and one or both of the collateral ligaments
• •Subject has a failed primary or revision knee replacement
• •Subject is 18-80 years of age
• •Subject is skeletally mature in Investigator's judgment i.e., subject is not actively growing or does not have immature bones for any reason
• •Subject has met an acceptable preoperative medical clearance and is free of or treated for cardiac, pulmonary, hematological, infection or other conditions that would pose excessive operative risk
• •Subject is willing to sign and date an IRB/EC-approved consent form
• •Subject plans to be available through the five (5) year postoperative follow-up
• •If of child bearing potential, Subject reports she is not pregnant nor plans to become pregnant during the study
• •Subject agrees to follow the study protocol