Total Knee Arthroplasty Functional Outcomes Study Research Design

This study aims to use up to 75 patients at 3 centers to determine a baseline short-term
post-operative 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 male or non-pregnant female age 18 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 with a primary diagnosis other than osteoarthritis of the knee as determined
by an orthopedic 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

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

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

- Patients with a known sensitivity to device materials

- Non-English speaking patients

- Patient is a prisoner