Comparison of Surgical Time and Efficiency of Total Knee Arthroplasty

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.

Inclusion Criteria:

- 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, in the opinion of the Clinical Investigator, is able to understand this
clinical investigation, and co-operate with investigational procedures.

- Subject, who, in the opinion of the Clinical Investigator, are suitable for
implantation using TruMatch™ instrumentation. For example, no femoral nails/bone
plates that extend into the knee, ie. 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 are consistent with TruMatch™ instrumentation.

Exclusion Criteria:

- The Subject is a woman who is pregnant or lactating.

- 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) of the
affected knee.

- 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 in the
PFC Sigma primary knee system.

- Subject who has inflammatory arthritis.

- Subject who has a Body Mass Index (BMI) of ≥ 40. (Please see Table 2-1: Definition of
Terms, for BMI definition and calculation formulas).