NexGen TM Tibia Clinical Outcomes Study

Inclusion Criteria

• Patient is at least 18 years of age.
• Patient qualifies for a primary cementless tibia total knee arthroplasty based on physical exam and medical history, including diagnosis of severe knee pain and disability due to at least one of the following:
• Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.
• Collagen disorders and/or avascular necrosis of the femoral condyle.
• Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy.
• Moderate valgus, varus, or flexion deformities.
• The salvage of previously failed surgical attempts that did not include partial or total knee arthroplasty of the ipsilateral knee.
• Patient has participated in the study-related Informed Consent process.
• Patient is willing and able to provide written Informed Consent by signing and dating the IRB approved Informed Consent Form.
• Patient is willing and able to complete scheduled study procedures and follow-up evaluations as described in the Informed Consent Form.
• Independent of study participation, patient is a candidate for commercially available cementless NexGen TM tibial knee component, implanted in accordance with product labeling.

Exclusion Criteria

• Previous history of infection in the affected joint.
• Active local or systemic infection that may 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.
• A stable, painless arthrodesis in a satisfactory functional position.
• Severe instability secondary to the absence of collateral ligament integrity.
• Rheumatoid arthritis accompanied by an ulcer of the skin or a history of recurrent breakdown of the skin.
• Patient has previously received partial or total knee arthroplasty for the ipsilateral knee.
• Patient is currently participating in any other surgical intervention studies or pain management studies.
• Patient is known to be pregnant or considered a member of a protected population (e.g., prisoner, mentally incompetent, etc.).
• Patient has a known or suspected sensitivity or allergy to one or more of the implant materials.