Zimmer POLAR Persona - TKA (EMEA Study)

Prior treatment

• Patient is currently participating in any other surgical intervention studies or pain management studies.
• Previous history of infection in the affected joint and/or other local/systemic infection that may affect the prosthetic joint.
• Patient has previously received partial or total knee arthroplasty for the ipsilateral knee.

Other illness

• Osteoporosis or any loss of musculature or neuromuscular disease that compromises the affected limb.
• Rheumatoid arthritis accompanied by an ulcer of the skin or a history of recurrent breakdown of the skin.
• Patient has a known or suspected sensitivity or allergy to one or more of the implant materials.

Other

• Insufficient bone stock on femoral or tibial surfaces.
• Skeletal immaturity.
• Neuropathic arthropathy.
• Stable, painless arthrodesis in a satisfactory functional position.
• Severe instability secondary to the absence of collateral ligament integrity.
• Patient is pregnant or considered a member of a protected population (e.g., prisoner, mentally incompetent, etc.).

• Patient 18-75 years of age, inclusive.
• Patient qualifies for primary 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 is willing and able to complete scheduled study procedures and follow-up evaluations.
• Independent of study participation, patient is a candidate for commercially available Zimmer Persona knee implants implanted in accordance with product labeling.