Accolade® TMZF® Hip Stem Outcomes Study

A prospective, post-market, multi-centered clinical evaluation of the Accolade® TMZF® hip
stem device. All patients enrolled will receive the study device. All study patients will
undergo a preoperative central Dual energy X-ray absorptiometry (DXA) scan to determine bone
mineral density (BMD) values.

Inclusion Criteria:

1. Patient is a candidate for a primary total hip replacement.

2. Patient has primary diagnosis of osteoarthritis (OA).

3. Male and non-pregnant female patients ages 18 to 90.

4. Patient has signed an Institutional Review Board (IRB) approved, study specific
Informed Patient Consent Form.

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

6. Patient capable of undergoing a pre-op central DXA (dual-energy x-ray absorptiometry)
scan for a bone mineral density (BMD) reading.

Exclusion Criteria:

1. Patient has an active infection within the affected hip joint.

2. Patient requires a revision surgery of a previously implanted total hip arthroplasty
or hip fusion to the affected joint.

3. Patient who is morbidly obese, Body Mass Index (BMI) > 40.

4. Patient has a neuromuscular or neurosensory deficiency, which limits ability to
evaluate the safety and efficacy of the device.

5. Patient has the following diagnosed systemic diseases: Paget's disease, renal
osteodystrophy, lupus erythematosus, rheumatoid arthritis, metabolic bone disease and
sickle cell anemia.

6. Patient is immunologically suppressed or receiving chronic steroids more than 30
days. Patients receiving oral or IV steroids within one month of surgery.

7. Patient is a prisoner.