Multi-Center Comparative Trial of the ASR™-XL Acetabular Cup System vs. the Pinnacle™ Metal- on- … (NCT00561600) | Clinical Trial Compass
CompletedNot Applicable
Multi-Center Comparative Trial of the ASR™-XL Acetabular Cup System vs. the Pinnacle™ Metal- on- Metal Total Hip System
United States265 participantsStarted 2006-11-01
Plain-language summary
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.
Who can participate
Age range20 Years – 75 Years
SexALL
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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 li…
What they're measuring
1
Composite Success Based Upon Harris Hip Score, Radiographic and Survivorship Outcomes