Multi-Center Comparative Trial of the ASR™-XL Acetabular Cup System vs. the Pinnacle™ Metal- on- Metal Total Hip System
NCT ID: NCT00561600
Last Updated: 2017-08-09
Study Results
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View full resultsBasic Information
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COMPLETED
NA
265 participants
INTERVENTIONAL
2006-11-01
2012-01-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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A
ASR™-XL Modular Acetabular Cup System stem
ASR™-XL Modular Acetabular Cup System
The ASR™-XL Modular Acetabular Cup System treatment device is comprised of a metal acetabular cup, a unipolar femoral head and a taper sleeve adapter.
B
Pinnacle™ acetabular shell, with a 28mm or 36mm ULTAMET® metal liner, and a 28mm or 36mm Articul/eze M head.
Pinnacle™ acetabular shell
The Pinnacle™ shells are cementless, titanium alloy cups with Porocoat® porous coating and HA DuoFix™ coating. There are various different liners available for use with the Pinnacle™ Acetabular Cup System. For the purpose of this investigation, the CoCrMo ULTAMET® 28mm or 36 mm metal liners will be used.
Interventions
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ASR™-XL Modular Acetabular Cup System
The ASR™-XL Modular Acetabular Cup System treatment device is comprised of a metal acetabular cup, a unipolar femoral head and a taper sleeve adapter.
Pinnacle™ acetabular shell
The Pinnacle™ shells are cementless, titanium alloy cups with Porocoat® porous coating and HA DuoFix™ coating. There are various different liners available for use with the Pinnacle™ Acetabular Cup System. For the purpose of this investigation, the CoCrMo ULTAMET® 28mm or 36 mm metal liners will be used.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
20 Years
75 Years
ALL
No
Sponsors
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DePuy Orthopaedics
INDUSTRY
Responsible Party
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Principal Investigators
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Dave Whalen, BS, DC
Role: STUDY_DIRECTOR
DePuy Orthopaedics
Locations
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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
Countries
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Other Identifiers
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04062
Identifier Type: -
Identifier Source: org_study_id
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