Gender Solutions Natural Knee Post-Market Study

Each investigator will screen from his patient population patients suffering from severe knee pain and disability who meet the inclusion/exclusion criteria for study participation.

Inclusion Criteria:

• Patient 18-75 years of age, inclusive;
• Patient qualifies for a total knee arthroplasty based on physical exam and medical history including at least one of the following: osteoarthritis, inflammatory arthritis, post-traumatic arthritis, rheumatoid arthritis, or valgus, varus, or flexion deformities;
• Patient has undergone a study related informed consent process;
• Patient is willing and able to provide written consent;
• Patient is willing and able to cooperate in the required post-operative therapy;
• Patient is willing and able to complete scheduled follow-up evaluations.

Exclusion Criteria:

• Patient has previous history of infection in the affected joint and/or a local or systemic infection that could affect the prosthetic joint;
• Insufficient bone stock on femoral or tibial surfaces;
• Skeletal immaturity
• Neuropathic arthropathy
• Osteoporosis or any loss of musculature or neuromuscular disease that compromises the affected limb;
• Stable, painless arthrodesis in a satisfactory functional position;
• Severe instability secondary to the absence of collateral ligament integrity;
• Patient has rheumatoid arthritis and an ulcer of the skin or a history of recurrent breakdown of the skin because of their risk of postoperative infection is greater;
• Patient has known sensitivity or allergy to one or more of the implanted materials;
• Patients pregnant or considered a member of a protected population (e.g., prisoner, mental incompetence, unable to understand what clinical trial participation entails, etc.)