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

Completed · Not applicable

Conditions studied: Non-inflammatory Degenerative Joint Disease

In brief

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.

Key facts

Study ID

NCT00561600

Run by

DePuy Orthopaedics

People needed

265

Starts

2006-11-01

Expected to finish

2012-01-01

Last updated by the study team

2017-08-09

Who can join

Age: 20 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Desert Orthopaedics — Rancho Mirage, California, United States
• Resurgens Orthopaedics — Cumming, Georgia, United States
• Illinois Bone and Joint Institute — Morton Grove, Illinois, United States
• Spectrum Health Hospital Research — Grand Rapids, Michigan, United States
• Dartmouth-Hitchcock Medical Center — Lebanon, New Hampshire, United States
• Eastern Oklahoma Orthopedic Center — Tulsa, Oklahoma, United States
• Orthopaedic Specialists of Austin — Austin, Texas, United States
• Valley Orthopaedic Associates — Renton, Washington, United States

Full record on ClinicalTrials.gov

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