Trident® X3 Polyethylene Insert Study

The study is a prospective, multi-center, historical-controlled clinical evaluation of the
Trident® X3 Polyethylene insert. The device is commercially available in the United States
where the study is being conducted. The study device, the Stryker Orthopaedics Trident® X3
polyethylene insert, is used for the replacement of the bearing surface of the acetabulum to
relieve pain, instability, and the restriction of motion due to degenerative bone disease,
including osteoarthritis, rheumatoid arthritis, trauma, or failure of other devices. The
control device, the Stryker Orthopaedics N2VAC polyethylene insert, is also used for the
replacement of the bearing surface of the acetabulum to relieve pain, instability, and the
restriction of motion due to degenerative bone disease, including osteoarthritis, rheumatoid
arthritis, trauma, or failure of other devices.

Inclusion Criteria:

1. The patient has signed an IRB-approved, study specific Patient Informed Consent Form.

2. The patient is a candidate for a primary total hip replacement with cementless
acetabular and femoral components.

3. The patient has a primary diagnosis of Non-Inflammatory Degenerative Joint Disease
(NIDJD). Patient must have diagnosis of osteoarthritis (OA), traumatic arthritis (TA),
avascular necrosis (AVN), slipped capital epiphysis, pelvic fracture, femoral
fracture, failed fracture fixation, or diastrophic variant.

4. The patient is a male or non-pregnant female patient ages 21 to 75.

5. The patient is willing and able to comply with postoperative scheduled clinical and
radiographic evaluations and rehabilitation.

Exclusion Criteria:

1. The patient has an active infection with the affected hip joint.

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

3. The patient has a BMI >45.

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

5. The patient has diagnosed systemic disease (i.e. Paget's disease, renal
osteodystrophy).

6. The patient is immunologically suppressed or receiving chronic steroids in excess of
5mg per day.

7. The patient has a recent history of substance dependency that may result in deviations
from the evaluation schedule.

8. The patient is a prisoner.