Alignment Comparison Between TruMatch™ Personalized Solutions and Conventional Total Knee Replacement Instrumentation

Exclusion Criteria

• •Subjects will be excluded from participation in the trial if they meet any of the following criteria:
• •The Subject has, in the opinion of the Investigator, an existing condition that would compromise their participation and follow-up in this study.
• •The Subject is a woman who is pregnant or lactating.
• •The Subject is a known drug or alcohol abuser or has a psychological disorder that could affect follow-up care or treatment outcomes.
• •The Subject has participated in a clinical investigation with an investigational product in the last 3 months.
• •The Subject is currently involved in any personal injury litigation, medical-legal or worker's compensations claims.
• •The Subject has previously had a prosthetic knee replacement device (any type including unicompartmental, total knee arthroplasty, patellofemoral arthroplasty) of the affected knee or a previous patellectomy.
• •The Subject presents ankylosis of the hip joint on the side to be treated or previous ipsilateral UTO/HTO.
• •The Subject requires simultaneous bilateral total knee replacements.
• •The Subject had a contralateral TKA and that knee was previously entered in the study.
• •Subject in whom the surgeon intends to implant a knee prosthesis that is not the cruciate retaining or posterior substituting PFC Sigma total knee arthroplasty.
• •Subjects who have inflammatory arthritis