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

The study is designed as a prospective, multi-center, non-randomized, clinical investigation to determine whether TruMatch™ alignment is non-inferior to alignment achieved in a recently completed study (historical control) with conventional instrumentation.

Each enrolled Subject will undergo a total knee replacement using the TruMatch™ surgical technique. This investigation will require the Subject to be followed once postoperatively to collect radiographs. Follow-up will occur typically 2 to 12 weeks after surgery and when the Subject can achieve full leg extension (+/-5 degrees) and can tolerate weight-bearing.

Inclusion criteria

• Subjects meeting all of the following specific criteria will be considered for participation in the study:
• Subject is male or female and between the ages of 18 and 80 years old, inclusive.
• Subject requires a primary total knee replacement and is considered by the Investigator to be suitable for the specific knee prosthesis identified in the protocol.
• Subject has given voluntary, written informed consent to participate in this clinical investigation and has authorized the transfer of his/her information to DePuy.
• Subject has given consent to the transfer of his/her information to DePuy.
• Subject, who, in the opinion of the Clinical Investigator at the time of preoperative planning, are suitable for implantation using TruMatch™ instrumentation and whose surgical plan (patient proposal) is approved. For example, no femoral nails/bone plates that extend into the knee, i.e. within 8cm of joint line; no metal device that could cause CT scatter about the knee and no deformities greater than 15 degrees of fixed varus, valgus, or flexion

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