Multi-Center Comparative Trial of the ASR™-XL Acetabular Cup System vs. the Pinnacle™ Metal- on- Metal Total Hip System

A Randomized, Prospective, Comparative, Multi-Center Clinical Evaluation of the DePuy ASR™-XL Acetabular Cup System vs. the Pinnacle™ Metal- on- Metal Total Hip System Study

The primary objective of this investigation is to evaluate the clinical and radiographic outcomes of the ASR™-XL Acetabular Cup System compared to the Pinnacle™ Acetabular Cup with a 28mm or 36mm ULTAMET™ metal insert.

The purpose of this clinical investigation is to gather sufficient clinical and radiographic data to permit valid scientific comparisons between treatment and control group outcomes. The treatment group/device for this study is the ASR™-XL Acetabular Cup System, and the control group/device is the Pinnacle™ Cup System w/ the 28mm or 36mm ULTAMET™ metal liner. The study objective will be achieved by way of treatment group selection, treatment administration, and management of participating study Subjects.

Inclusion Criteria:

• Subject is able to or capable of providing consent to participate in the clinical investigation.
• Subject is between the ages of 20-75 years, inclusive.
• Subject requires a cementless, primary total hip arthroplasty for non-inflammatory degenerative joint disease (NIDJD).
• Subject has sufficient bone stock for the hip replacement device.
• Subject is a suitable candidate for the devices specified in the clinical investigation plan and is willing to be randomized to either cup system device.

Exclusion Criteria:

• Subject, in the opinion of the Investigator, has an existing condition that would compromise his/her participation and follow-up in this investigation.
• Subject with a known allergy to metal (e.g. jewelry).
• Subject has inflammatory arthritis (e.g. rheumatoid arthritis).
• Subject has active or recent joint sepsis.
• Subject with marked atrophy or deformity in the upper femur.
• Subject with a neuromuscular disease where the loss of musculature would affect functional outcome.
• Subject, in the opinion of the Clinical Investigator, has a history of chronic renal insufficiency (e.g. dialysis).
• Subject is receiving systemic steroid therapy, excluding inhalers or intra-capsular injections, within 3 months prior to surgery.
• Subject with known, active metastatic or neoplastic disease.
• Subject is known to be pregnant, a prisoner, mentally incompetent, and or alcohol or drug abuser.
• Subject is currently involved in any personal injury litigation, medical legal or worker's compensation claims.