LEGION Hinge Safety and Efficacy Study

The objective of this study is to demonstrate statistically significant improvements in the original Knee Society Clinical Score (KSCS) from baseline to 1 and 2 years in subjects using the LEGION™ Hinge Knee System. The focus of the 1 and 2 year analyses will be on safety and efficacy. The 5 year analysis will focus on survivorship and safety.

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

Exclusion criteria

• Subject is receiving the study device as a primary knee replacement
• Subject has presence of malignant tumor, metastatic, or neoplastic disease
• Subject is not expected to return to normal ambulatory function (i.e., morbid obesity or other limiting co-morbidities)
• Subject is pregnant or plans to become pregnant during the course of the study
• Subject has conditions that may interfere with the revision arthroplasty survival or outcome (i.e., Paget's or Charcot-Marie-Tooth disease, vascular insufficiency, muscular atrophy, uncontrolled diabetes, moderate to severe renal insufficiency or neuromuscular disease)
• Subject has known (Subject reported) metal hypersensitivity
• Subject has an emotional or neurological condition that would pre-empt their ability or willingness to participate in this study
• Subject has BMI>45
• Subject is participating in any other pharmaceutical, biologic, or medical device clinical investigation or has been treated with an investigational product in the past 30 days
• Subject is facing current or impending incarceration
• Subject is not a good candidate for the study based on Investigator opinion