Prospective Functional Outcome Study of the Knee

This study aims to use up to 75 patients at 3 centers to determine a baseline short-term
postoperative physical function status of patients undergoing a total knee arthroplasty
through patient and clinically based assessments. The KOOS score will collect data on the
patient's physical function, stiffness, and pain. The BERG balance, TUG, and TUDS tests will
be used quantitatively to assess the patient's ability to conduct activities of daily living
like walking for an extended period of time, standing from a seated position, and maintaining
balance while performing a series of actions.

Inclusion Criteria:

- Patient is a male or non-pregnant female age 55 years or older at time of study

- Patient is a candidate for a total knee arthroplasty

- Patient is willing and able to comply with postoperative scheduled clinical and
radiographic evaluations and rehabilitation.

Exclusion Criteria:

- Patients younger than 55 years of age

- Patients with a primary diagnosis other than osteoarthritis of the knee as determined
by an orthopaedic surgeon

- Patients who have had any previous lower extremity procedure

- Patients with a BMI greater than or equal to 40

- Patients with an active infection within the affected knee joint Patients with a
neuromuscular or neurosensory deficiency that may limit the ability of the patient to
evaluate the safety and efficacy of the device

- Patient is diagnosed with systemic disease or metabolic disorder leading to
progressive bone deterioration (e.g. Lupus Erythematosus, Paget's Disease)

- Patient is immunologically suppressed or receiving chronic steroids in excess of
normal physiological requirements (e.g. greater than 30 days)

- Patient has a known sensitivity to device materials

- Non-English speaking patients

- Patient is a prisoner