Triathlon® Cruciate Retaining (CR) Total Knee System Outcomes Study

The Triathlon® Cruciate Retaining (CR) Total Knee System components are for use in cemented
total knee arthroplasty for painful, disabling joint disease of the knee resulting from
non-inflammatory degenerative joint disease (including osteoarthritis, traumatic arthritis or
avascular necrosis) or rheumatoid arthritis (excluded from this study according to protocol).
The components are designed to improve range of motion (ROM) and stability. This study serves
to demonstrate that subjects have reduced pain, increased ROM and improved stability
following implantation with the Triathlon Cruciate Retaining (CR) Total Knee System as
compared to the historical control.

Inclusion Criteria:

1. The subject is a male or non-pregnant female between the ages of 21 and 80.

2. The subject requires a primary cemented total knee replacement.

3. The subject has a diagnosis of osteoarthritis (OA), traumatic arthritis (TA), or
avascular necrosis (AVN).

4. The subject has intact collateral ligaments.

5. The subject has signed the IRB-approved, study specific Informed Patient Consent Form.

6. The subject is willing and able to comply with postoperative scheduled clinical and
radiographic evaluations and rehabilitation.

Exclusion Criteria:

1. Patient has inflammatory arthritis.

2. The subject is morbidly obese, BMI > 40.

3. The subject has a history of total or unicompartmental reconstruction of the affected
joint.

4. Patient has had a high tibial osteotomy or femoral osteotomy.

5. The subject has no obvious charcot (i.e. a neuromuscular or neurosensory deficiency,
which would limit the ability to assess the performance of the device).

6. The patient has a systemic or metabolic disorder leading to progressive bone
deterioration.

7. The subject is immunologically suppressed, or receiving chronic steroids (> 30 days
duration).

8. The subject's bone stock is compromised by disease or infection, which cannot provide
adequate support and/or fixation to the prothesis.

9. The subject has had a knee fusion to the affected joint.

10. The subject has an active or suspected latent infection in or about the knee joint.

11. The subject is a prisoner.