A Prospective Multi-center Study on Total Hip Arthroplasty With E1

A Prospective Multi-center Randomized Study on Total Hip Replacement With E1

The primary objectives of this clinical study include:

• Evaluate E1 Wear including early bedding-in process, clinical outcomes on patients who received Total Hip Arthroplasty with E1
• Compare E1 wear used with CoCr and Biolox Delta heads

This study is designed as PROSPECTIVE, RANDOMIZED, MULTI-CENTER Study to compare two different materials (CoCr and Delta ceramic) articulating against E1 Highly Crosslinked polyethylene in Hip Replacement.

Patient population is 160 (80 each). Follow-up period is 10 year postoperatively. E1 liners with thickness of 4.8mm at 45 degrees position (load bearing direction) will be used in all cases.

Randomization will occur via random number generator by 4 blocks randomization.

Inclusion Criteria:

• Osteoarthritis
• Age between 20 - 75 at the time of operation
• Patients with limited co-morbidity -ASA I-III
• Patients must be able to understand instructions and be willing to return for follow up

Exclusion Criteria:

• In accordance with approved Absolute and Relative Contraindications for use in participating countries for E1 liner and Delta Ceramic and CoCr femoral head hip system System.

Absolute contraindications include: infection, sepsis, and osteomyelitis.

Relative contraindications include:

1. uncooperative patient or patient with neurologic disorders who are incapable of following directions,
2. osteoporosis,
3. metabolic disorders which may impair bone formation,
4. osteomalacia,
5. distant foci of infections which may spread to the implant site,
6. rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram, and
7. vascular insufficiency, muscular atrophy, or neuromuscular disease.
8. pregnancy